AnnexG_NewFormatTerms.

csv_Final
Annex Name: Annex G
Annex Title: Medical Device Component
Release Number: 2024
Annex Description:
Terms/codes for describing the parts and components
which were involved in, or affected by, the medical
device adverse event/incident.
Annex Instructions:
These terms allow capturing of the specific part or
component of the medical device which was involved in
the incident. In the case that a component is also a
stand-alone device, the Annex G term should not be
used. IMDRF Terms and Definitions use American
spelling.

Annex Approval Date: 18 January 2024

Level 1 Term Level 2 Term

Biological and Chemical

Absorber
Cautery Tip
Device Ingredient or Reagent
Gas Scavenging
Monomer Liquid
Test Strip
Polymer Powder
Electrical and Magnetic

Antenna
Battery
Battery Charger
Cable, Electrical

Circuit Board
Circuit Breaker
Computer Hardware

Computer Software

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Cooling Module
Device Programmer
Device Reader
Discrete Electrical Component

IC (Integrated Circuit) Chip

Display

Electrical Lead/Wire

Electrical Mixer
Electrical Port
Emitter
Headphone/Headset

Heater
Hub
Inverter
Magnet
Oscillator
Patient Lead

Power Cord
Power Supply
Pressure Transducer Probe
Printer
Receiver
Receiver Stimulator Unit

Scanner

Speaker/Sounder
Switch/Relay

Telemetry

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Temperature Compensator

Thermostat
Transformer

Transmitter
User Input Device

Measurement
Analyzer

Aperture
Calibrator
Clock
Counter
Cuvette
Gauges/Meters

Marker
Pipette
Pointer
Scale
Sensor

Timer
Control Material

Swab

Tray

Mechanical
Access Port
Actuator
Adapter (Adaptor)
Air Eliminator
Anchor

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Applicator
Automatic Injection System
Bag
Ball
Balloon
Bearings
Bellows
Belt
Bottle
Breathing Circuit

Brush
Bushing
Cable, Mechanical/Structural
Cannula

Cap
Carrier
Caster
Catheter

Cell
Chain
Chamber
Chassis/Frame
Clutch
Coating Material
Coil

Collimator

Concentrator
Cone
Connector/Coupler

Controller
Compressor
Cover
Cuff
Cup
Cusp/Leaflet
Cutter/Blade
Cylinder
Device Collapser
Device Deployer
Diaphragm

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Dome
Ejector
Equipment Pole
Extender
Fabric
Fan/Blower
Fastener

Fiber
Filter
Flange
Foil
Gas Exchanger
Gasket
Gears
Generator
Guide
Guidewire
Handpiece
Header
Sewing Ring
Heat Exchanger
Hinge
Holder
Hose
Housing
Humidifier
Hydraulic System
Impeller
Inserter
Insulation
Isolator
Jaw

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Joint
Knob
Label
Leaflet

Lever

Liner
Magazine/Cassette
Manifold
Mask
Mechanical Mixer
Membrane
Mesh
Motor(s)
Mount
Needle
Nozzle
Packaging
Pad

Panel
Plate

Plug
Plunger
Post
Potting
Probe
Processor
Pulley
Pump
Pusher
Rachet
Rail

Regulator
Reservoir
Ring
Rod/Shaft
Seal
Shock Absorber
Sleeve
Slide
Socket
Spacer
Spring

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Stand
Steering Wire
Stent
Stopcock
Stopper
Strain Relief
Stylet
Syringe
Table
Tip
Tool

Translational Motion Component

Trap
Trocar
Tube

Valve(s)

Vaporiser
Vibrator
Washer
Weld
Wheel
Window
Shutter
Optical
Camera

Film
Imager
Laser
LED (Light Emitting Diode)
Lenses
Light Source

Mirror
Optical Fiber
Safety
Alarm

Emergency Button Or Switch

Fail-Safe System
Locking Mechanism
Protector/Shield
Safety Interlock

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Safety Valve
Others

Part/Component/Sub-assembly Term not Applicable

Appropriate Term/Code Not Available

Insufficient information

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Level 3 Term Code

G01

G01001
G01002
G01003
G01004
G01005
G01006
G01007
G02

G02001
G02002
G02003
G02004
Cable Grip/Tie G0200401

Cable Sleeve G0200402

G02005
G02006
G02007
Computer Processor G0200701

Memory/Storage G0200702
Network Interface G0200703
G02008
Driver G0200801
Software Interface G0200802
User Interface G0200803

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Firmware G0200804

G02009
G02010
G02011
G02012
Capacitor G0201201
Fuse G0201202
Inductor G0201203
Resistor G0201204
Solenoid G0201205
Transducer G0201206
Semiconductor G0201207
G02013
G02014
Indicator G0201401
Screen G0201402
G02015
Electrode G0201501

Ground Strap/Wire G0201502

Wiring Harness G0201503
G02016
G02017
G02018
G02019

G02020
G02021
G02022
G02023
G02024
G02025
Lead Conductor G0202501
Patient Electrode G0202502
G02026
G02027
G02028
G02029
G02030
G02031

G02032

G02033
G02034
Power Switch G0203401
Relay G0203402
G02035

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G02036

G02037
G02038

G02039
G02040
Joystick G0204001
Keyboard/Keypad G0204002
Microphone G0204003
Touchscreen G0204004
G03
G03001
Oxygen Analyzer G0300101
G03002
G03003
G03004
G03005
G03006
G03007
Flowmeter G0300701
Manometer G0300702
Thermometer G0300703
G03008
G03009
G03010
G03011
G03012
Bubble Sensor G0301201
O2 Sensor G0301202
Photodetector G0301203
Pressure Sensor G0301204
Sensor Probe G0301205
Temperature Sensor G0301206
G03013
G03014

G03015

G03016

G04
G04001
G04002
G04003
G04004
G04005

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Fixation Tines G0400501

G04006
G04007
G04008
G04009
G04010
G04011
G04012
G04013
G04014
G04015

G04016
G04017
G04018
G04019
Cannula Hub G0401901
G04020
G04021
G04022
G04023
Catheter Hub G0402301
G04024
G04025
G04026
G04027
G04028
G04029
G04030
Fixation Helix G0403001

G04031

G04032
G04033
G04034
Connector Pin G0403401
G04035
G04036
G04037
G04038
G04039
G04040
G04041
G04042
G04043
G04044
G04045

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G04046
G04047
G04048
G04049
G04050
G04051
G04052
Adhesive G0405201
Bolt G0405202
Clamp G0405203
Clip G0405204
Fixation Wire G0405205
Latch G0405206
Nail G0405207
Nut G0405208
Pin G0405209
Prong G0405210
Retainer G0405211
Rivet G0405212

Screw G0405213
Staple G0405214
Suture Thread G0405215

Tape for Fixation G0405216

G04053
G04054
G04055
G04056
G04057
G04058
G04059
G04060
G04061
G04062
G04063
G04064
G04065
G04066
G04067
G04068
G04069
G04070
G04071
G04072
G04073
G04074
G04075
G04076
G04077

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G04078
G04079
G04080
G04081

G04082
Foot Pedal G0408201
G04083
G04084
G04085
G04086
G04087
G04088
G04089
G04090
G04091
G04092
G04093
G04094
G04095

G04096
G04097

G04098
G04099
G04100
G04101
G04102
G04103
G04104
G04105
G04106
G04107
G04108
Side Rail G0410801
G04109
G04110
G04111
G04112
G04113
G04114
G04115
G04116
G04117
G04118
G04119

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G04120
G04121
G04122
G04123
G04124
G04125
G04126
G04127
G04128
G04129
G04130

G04131
G04132
G04133
G04134
Capillary Tube G0413401
G04135
Control Valve G0413501
Luer Valve G0413502
One-Way Valve G0413503
G04136
G04137
G04138
G04139
G04140
G04141
G04142
G05
G05001

G05002
G05003
G05004
G05005
G05006
G05007
Bulb G0500701
G05008
G05009
G06
G06001
Alarm, Audible G0600101
Alarm, Visual G0600102
G06002
G06003
G06004
G06005
G06006

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Needle Stick Prevention Mechanism G0600601
G06007
G07

G07001

G07002

G07003

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Definition
Component whose mode of action involves a biological process (ex. test strip which acts on antibodies) and chemical reaction
activated charcoal absorber).
A component or material designed to take in or attenuate a substance.
A component designed to coagulate and seal blood vessels or to destroy tissue with heat or electric current.
A consumable material that is added to a device and is used to make a finished product or becomes part of a finished product
A component designed to remove certain gases from a gas stream or environment.
The liquid that reacts with the polymer powder to form adhesive, resin, or cement.
A piece of chemically treated medium designed to react in the presence of specific amounts of a trigger substance.
The powder that reacts with the monomer liquid to form adhesive, resin, or cement.
Components which relates to the force of magnetism or such as microchips and transistors which control and direct electric cu
components involved in the representation, storage, or transmission of information by electronic systems.
A component designed to transmit or receive electromagnetic signals.
A component designed to produce an electric current through chemical reaction.
A device designed to restore the capacity of a battery.
A long, thin, multistranded electrical wire designed to carry signals or power over a distance.
Component used for tensioning, pulling, holding or stringing of wires and cables.

Component used to protect cables and wires from abrasion, moisture and the elements.
A non-conducting board with conductive tracks and electronic components forming a circuit.
A component designed to open an electrical circuit when it becomes overloaded.
The physical components from which a computer is constructed (electronic circuits and input/output devices).
Component that carries out the instructions of a computer program by performing the basic arithmetic, logic, controlling, and in
specified by the instructions.
Any component that can hold data in machine-readable format.
Point of interconnection between a computer and other computer that are linked each other.
A collection of data or computer instructions that tell the computer how to work.
A computer interface designed to control the interaction between a CPU and a peripheral device.
Languages, codes and messages that programs use to communicate with each other and to the hardware.
A computer program that controls the interaction between a user and a system.

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Computer instructions and data that reside as read-only software on that device. The computer cannot modify such software d

A component designed to lower the temperature of a device or system.

A piece of hardware for transferring data onto programmable integrated circuits.
A piece of hardware used to read the memory and the properties of a device.
An electrical component which is just one circuit, either passive or active, that is not an integrated circuit.
An electrical component designed to store an electric charge.
An electrical component designed to stop the flow of current when an overload condition exists.
A component designed to introduce electromotive force to a circuit, usually a coil surrounding a wire.
An electronic component that opposes the flow of current.
An electronic component consisting of a coil surrounding a movable iron core that is designed to act as a switch or relay.
An electrical component that converts one form of energy into another.
A type of electronic component, including transistors and diodes, that make use of the variable conductivity of certain material
A microelectronic circuit that incorporates many interconnected transistors and other components.
A component designed to present information visually. In the case of Touchscreen, use G0204004.
A component designed to show an operating condition of a system or to attract attention.
A panel or area on an electronic device where images and data are displayed.
A coated or uncoated wire used to connect two locations electronically. Not to be used for patient connection.
A small piece of metal or other conductive substance this is used to take an electric current to or from a source of power, a pie
be used for patient connection.
A wire cable or strap designed to carry current safely away from an electronic device under fault condition
A collection of grouped wires or cables designed to connect to a specific device.
An electronic component designed to blend signals.
An electronic circuit that acts as a connection to another device or component.
The electron source electrode in a transistor or any source in a system.
A component that covers the ear through which you can listen to without other people hearing. Some headphones come with
used to communicate with other people or the device.
A piece of equipment used to raise the temperature of air, gas or water or an object.
An electronic component designed as a central connection for other devices or components.
An electrical component that converts direct current to alternating current.
A component that attracts iron and produces a magnetic field.
An electronic component designed to produce a wave signal.
An insulated electrical cable designed to connect to an electrical device to a patient.
A cable designed to conduct electricity from the device to the lead.
An electrical conductor that is designed to make contact with a patient including defibrillator paddles.
A flexible cable designed to connect an electrical device to a power outlet.
Component designed to supply electrical power to devices.
A probe component designed to convert a change in pressure into a varying electrical signal.
An electronic component that is designed to transfer text or images to paper or other substrate.
An electronic component designed to capture an incoming electromagnetic signal and convert it to an audible or visual signal.
As part of a cochlear implant, an implanted component designed to receive signal from the external component and then deco
transmit it to the brain.
An electronic component that generates a digital representation of an image for data input to a computer; or a receiver design
within a specified frequency range.
A component designed to convert electrical signals to sounds that can be heard.
A mechanical or electronic component designed to break or change the connections in a circuit (e.g. button).
A switch designed to regulate the power to a device.
A electronic component designed to break or change the connections in a circuit.
Component designed to transmit and receive data from a remote source using telecommunications methods.

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A component designed to compensate the temperature of one system in response to temperature changes in another system

A component designed to regulate temperature by controlling the starting and stopping of a heating/cooling system.
A component that either steps up or steps down an alternating electrical current to an output that is suitable for another electri
component.
A component to propagate electromagnetic waves.
A component that uses a movable handle to create two-axis input to a computer.
A control component that uses a movable handle to create two-axis input to a computer.
A component consisting of mechanical keys that are pressed to create input to a computer.
A component designed to convert sound to an electrical signal.
A control component that operates the device following pressing the display on the screen.
Component capable of measuring something in order to obtain a result.
Any component designed to perform an analysis.
A component designed to measure the concentration of oxygen in a gas mixture.
An instrument designed to measure the size of an opening or one used to increase the diameter of an opening
A standard or reference material used to set the operating parameters of an instrument.
A component designed to indicate the time of day.
A component designed to keep track of the number of times something happens.
A clear container designed to interface with an optical sensor in order to obtain an optical measurement of a contained substa
A component designed to give a visual indication of the condition of a system.
A component designed to measure the flow rate of a fluid.
A component designed to measure pressure.
A component designed to measure temperature.
A visual indicator of position, place or route, including radiopaque markers.
A measuring component, traditionally including a graduated tube, designed for the accurate transfer of liquid volumes.
An indicator component designed to show a position on a scale.
A component designed for weighing or an indicator component with a graduated sequence of divisions.
A component designed to respond to a stimulus by generating a signal that can be measured or interpreted.
A component designed to signal the presence of bubbles in a system.
A sensor designed to respond to the presence or level of oxygen in a space or environment.
A component designed to detect light.
A sensor designed to respond to the level of pressure in a space or pressing on a surface.
A component designed to reach into a location for sensing. Should be used when the problem involves the probe, not the sen
A sensor designed to respond to the temperature of a space, surface, or environment.
A component designed to measure a time interval.
A standard or reference material used for the purposes of comparative evaluations.

An absorbent pad or piece of material attached to the end of a stick typically used for applying medicines or taking specimens

A flat, shallow container with a raised rim.

Component of a device when it is working, often using power from an engine or from electricity.
A component designed for the introduction or removal of medical equipment or any substance.
A component which moves or controls a mechanism or system.
A component designed to make different pieces of apparatus compatible.
A component designed to remove air from a space or fluid.
A component designed to fix the device or a portion of the device in place.

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Projections designed to fix a device inside a cavity of the human body

A component designed to transfer a substance to a surface.

A system designed to pump a gas or liquid into a space or environment without outside intervention.
A flexible container, often with a single opening.
Any component that is spherical in shape.
A sac designed to be inflated and deflated.
A point of contact between moving parts designed for support or to reduce friction.
A component that expands and contracts to draw in air through a valve or orifice and expels it through a tube.
A component consisting of a narrow band of material moving over shafts or pulleys.
A rigid or semi-rigid container used to store liquid.
In an anesthesia machine, the pathway by which a gaseous anesthetic agent and oxygen are delivered to the patient and carb
The circuit can be open or closed.
A component consisting of hairs or bristles set into a handle or holder.
A cylindrical metal sleeve designed to reduce the friction of a rotating shaft.
A long, thin, multistranded rope or metallic wire to hold the subject.
A rigid or semi-rigid tube inserted into the body.
A metal or plastic component that connects to the cannula.
A component designed to close an opening of a container or device.
A component designed to facilitate the support, movement, or transport of another device or object.
A pivoting roller or wheel designed to attach to an object to make it movable.
A flexible tube inserted into the body designed to permit injection or withdrawal of fluids or to keep passage open.
A small metal or plastic component that connects to the catheter.
A component that is designed as a container to collect and/or transfer materials, reagents or specimens.
Assembly of interconnected links, typically made of metal used for connecting other components.
A component designed as a reservoir/storage.
A supporting frame designed to hold other components or devices such as the internal frame of an electronic device.
A component that engages and disengages power transmission.
A layer of material covering the surface of a device.
A structure consisting of something wrapped in a continuous series of loops.
A coil designed for fixing or anchoring a device in human tissue.

A diaphragm or system of diaphragms made of an absorbing material, designed to define and restrict the dimensions and dire
radiation.
A component designed to increase the weight per unit volume of a substance.
A three-dimensional part that tapers smoothly from a flat circular shape at one end to a point at the other end.
A component designed to serve as a link between parts allowing easy disconnection and reconnection when necessary.
A projecting part of a device that allows it to be secured through an opening.
A component designed to control or regulate the operation of another device.
A component that increases the pressure of air or gas.
An object designed to conceal, enclose, or protect something.
A bandlike structure that encircles a body part or another component or device.
Part or design of a device with a concave hemispherical shape.
A thin blade-like component, typically used as part of a one-way valve.
A component designed for slicing or cutting.
A three-dimensional part with flat circular ends and long straight sides.
A component designed to fold or collapse something.
A component designed to install something or distribute something in a systematic way.
A component consisting of a flexible sheet or partition.

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Part or design of a device with a convex hemispherical shape.
A mechanism that pushes a device or component out.
A structural component designed to hang medical equipment.
A component designed to lengthen a structure.
Cloth produced from textile fibers.
A component designed to create an air current through the rotation of a planar surface.
A component designed to hold items in place.
Any substance that affixes 2 or more surfaces together. This may be supplied separately, or attached to another item such as
A cylindrical connector element which may have a thread/nut connection to form a fastener.
A component designed to mechanically hold items firmly together.
A small component designed to hold and attach items together.
A metal strand designed for structural or other purpose.
A fastening component for a mobile part usually consisting of a bar that is retained in a slot.
A pin-shaped fastener with a sharp point at one end and usually flat on the other end.
A threaded fastener designed to engage a bolt.
A small, slender separate component which is designed to secure another object.
A projecting pointed part of a device, usually one designed to attach a device to something else.
A physical component designed to hold items in place.
A fastening component resembling a heavy pin, having a head on one end and designed to have the other end flattened after
parts to be connected.
A fastening component with a tapered threaded shaft and a head designed to engage with a driving tool.
A fastening component consisting of a bent wire designed to pierce and hold two or more surfaces together.
A monofilament or multifilament material used surgically to close a wound, join tissues, or fasten components of a device (e.g
frame).
A long, thin, flat, flexible material often used for binding or fastening.
Any component made from a long, slender material.
A component designed to remove something from whatever passes through it.
A protruding edge designed to strengthen or stabilize a device or facilitate its attachment to a surface.
A thin, flexible sheet of metal.
Component that is used to transfer gasses between two or more locations.
A preformed material designed to form a seal between connecting surfaces.
A toothed wheel designed to mesh with another toothed object and transmit motion.
A component designed to produce electricity, vapor or gas.
A component designed to help direct the passage of another object.
A flexible wire designed to help position medical devices within the body.
A part of a device designed to be used while held in the hand.
The connection point between the leads and the generator.
A ring of supportive material designed to provide a stable surface for attachment to surrounding tissues.
A component designed to transfer heat between fluids and/or gases across a barrier or to the environment.
A component designed to join two objects and allow them to swing relative to one another.
A component designed to hold another object.
A flexible tube designed to carry a fluid or gas.
A rigid casing that encloses and protects a piece of equipment.
A component used to increase moisture in a gas.
A system designed to use fluid pressure to bring about movement.
The rotating component of a centrifugal pump, compressor, or other machine designed to move a fluid by rotation.
A component whose function is to facilitate the insertion of a particular device.
A material designed to reduce the transmission of heat, sound, or electricity.
Any material or structure designed to limit the interaction between two components.
A component designed to use opposing parts to close on and hold an object.

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A component designed as the junction between objects; it may be flexible or rigid.
A rounded lump or ball used for adjusting or controlling.
Any written, printed, or graphic matter upon a device to identify its nature, ownership, or other characteristics of the device.
A device consisting of two thin blades hinged in the center; typically designed to control flow of fluids.

A rigid bar that rotates around a fixed point.

A lever designed to be operated with the foot.
A component placed the inside of the walls of a cavity or container for protection or insulation.
A compartment in a device designed to house a consumable material for feeding into a mechanism.
A branched system of pipes or channels; typically to funnel the flow of liquids or gases.
A flexible, form-shaped component designed to be placed over the nose and/or mouth.
A mechanical component designed to blend materials.
A component that is made from or resembles a thin flexible sheet of material acting as a boundary or separating two chamber
Component made of overlapping strands forming a fine net-like structure.
A machine that converts any form of energy to produce or impart motion (kinetic energy).
A structural component designed to facilitate the attachment of one object to another.
A component with a long, slender, pointed shape.
A component designed to regulate and direct the flow of a fluid or gas.
The outer wrapping around a device which serves to contain, identify, and protect it prior to use.
Typically a soft, cushion-like material used to prevent injury or damage to a person or device. Can also be made of an absorb
liquid.
A rigid sheet that forms a surface of a device or component.
A thin, flat sheet or strip used to join, strengthen or to form parts of another structure. For a flat, shallow container with a raise
Tray.

A component designed to seat into an opening in a device or other object.

A component of a machine, tool or device that pushes or thrusts another object, liquid or gas.
An upright piece that is fixed firmly that supports, place or aligns other parts.
The resin, glue or other substance used to seal other components together.
A component designed to reach into a location for manipulating or for measuring.
A component designed for preparing or treating a material. Should not be used for computer processors.
A component which changes the direction of a force (e.g. belt or chain).
A component designed to facilitate the movement of a fluid.
A component designed to advance something by pushing it.
A part that allows or forces another part's movement in a single direction.
A bar designed for support, attachment, guidance, or protection from falling.
A supportive or protective rail attached to the side of something.
A component designed to control a process or condition.
A vessel designed to store a fluid.
A circular band-shaped component.
A long cylindrical bar used to transmit motion or connect other components.
A component designed to prevent passage of material through a joint or opening.
A mechanical component designed to dampen or attenuate a force.
A cylindrical fitting that slides over another part of a device or other object.
A flat rectangular piece of glass on which specimens can be mounted for microscopic study.
A component designed as an opening into which something else fits.
A component designed to position objects further apart.
An elastic component designed to bend under a load and then return to its shape when unloaded.

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A support component designed to hold an object.
A wire designed to enable a device to be maneuvered.
Tubular support placed inside a blood vessel, canal, or duct to aid healing or relieve an obstruction.
A rotating component designed to act like a tap for regulating the flow of a fluid, and to completely stop the flow when closed f
Component designed to close an opening.
A structure designed to function with a connector to prevent damage to a hose or cable from excess flexing.
A thin metal wire designed to be passed through a needle, catheter, or cannula to stiffen it or clear it of debris.
A component designed as a rigid cylinder with a plunger at one end and a delivery opening at the other.
A component having a smooth flat surface that is usually supported by one or more vertical legs.
Pointed or rounded end of an object.
A component that is delivered with a device to support its assembly or operation, and is not part of the device. Use only in the
terms to describe the component.
A rotating part which is intended to transfer rotational movement or motion to another type of movement (e.g. excenters).
A component designed to capture or remove bubbles or fluid.
A sharp, pointed rod designed to pierce the wall of a body cavity to withdraw fluid or allow placement of a catheter or other de
A long hollow cylinder, either rigid or flexible, for holding or transporting liquids or gasses.
A narrow tube in which a liquid flows up against gravity.
A mechanical component designed to control the flow of a fluid or gas.
A valve designed to regulate the flow of a fluid or gas.
A valve that incorporates a Luer fitting.
A valve designed to allow flow in only one direction.
A component for gasifying liquids such as drugs.
A mechanical component designed to create a vibratory motion.
A flattened disk used as a mechanical seal between objects.
Any joining connection that is the result of welding 2 or more parts.
A mechanical component consisting of a spoked, circular rim or solid disk designed to rotate on an axle or shaft.
A transparent panel in a device designed for visual inspection or to let light pass.
Aperture that controls or blocks light or radiation passing through.
Component which involves or relates to vision, light, or images.
An apparatus for taking photographs, generally consisting of a lightproof enclosure having an aperture with a shuttered lens th
of an object is focused and recorded.
A photographic material designed to capture an image upon exposure to electromagnetic radiation.
A component designed to create or record a visual representation.
A component designed to emit a monochromatic beam of coherent light.
A type of diode designed to emit light when a current passes through it.
An electric or optical component designed to focus (concentrate) or disperse electromagnetic radiation.
A component that produces visible light.
A component designed to produce light or heat.
A component consisting of a polished surface designed to reflect light.
A component made with thin glass fibers as a conduit for transmission of light.
Safety related component
A component designed to signal the occurrence of a particular event.
A component designed to signal the occurrence of a particular event by making a sound.
A component designed to signal the occurrence of a particular event in a way that can be seen.
A button and circuits designed to force the shutdown of a machine or device.
A component designed to prevent malfunction, unsafe, or unauthorized operation of a device or system.
A fastening component designed to hold, close, or secure.
A component designed to prevent harm or protect against damage to other components.
A mechanical or electronic component designed to prevent undesired actions due to the changing state of a device, typically t
operator or damage to the device itself.

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 AnnexG_NewFormatTerms.csv_Final
A mechanism integrated into a device to prevent needle stick injuries.
A valve designed to automatically open in order to maintain the pressure in a system below a specified pressure.
Others.

The device does not have distinct parts, components, or sub-assemblies, or it would not be appropriate to link the reported inc
component, or sub-assembly. Use this term if the problem involves or affects the overall device rather than a specific compon
The parts, components, or sub-assemblies are not adequately described by any other term. Note: this code must not be used
feasible code. The preferred term should be documented when submitting an adverse event report. This information will be us
term should be added to the code table.
There is not yet enough information available to classify the medical device component.

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Non-IMDRF Code/Term Status

Not selectable

Not selectable

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 AnnexG_NewFormatTerms.csv_Final

Not selectable

Not selectable

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 AnnexG_NewFormatTerms.csv_Final
New

Modified (technical)

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Not selectable

Not selectable

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Not selectable

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Status Description CodeHierarchy

Please use more detailed term within the hierarchy G01

G01|G01001
G01|G01002
G01|G01003
G01|G01004
G01|G01005
G01|G01006
G01|G01007
Please use more detailed term within the hierarchy G02

G02|G02001
G02|G02002
G02|G02003
G02|G02004
Term/definition was modified on 31 January 2023 (Old G02|G02004|G0200401
term/definition: Cable Grip: Component used for
tensioning, pulling or stringing of wires and cables.). For
details, see comment No. 151 of the Change Log
(Release Number 2023).
G02|G02004|G0200402
G02|G02005
G02|G02006
G02|G02007
G02|G02007|G0200701

G02|G02007|G0200702
G02|G02007|G0200703
G02|G02008
G02|G02008|G0200801
G02|G02008|G0200802
G02|G02008|G0200803

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Term was added on 31 January 2023. For details, see G02|G02008|G0200804
comment No. 144 of the Change Log (Release Number
2023).
G02|G02009
G02|G02010
Editorial change to the definition on 16 February 2021. G02|G02011
G02|G02012
G02|G02012|G0201201
G02|G02012|G0201202
G02|G02012|G0201203
G02|G02012|G0201204
G02|G02012|G0201205
G02|G02012|G0201206
G02|G02012|G0201207
G02|G02013
G02|G02014
G02|G02014|G0201401
G02|G02014|G0201402
G02|G02015
Editorial change to the definition on 16 February 2021. G02|G02015|G0201501

G02|G02015|G0201502
G02|G02015|G0201503
G02|G02016
G02|G02017
G02|G02018
G02|G02019

Editorial change to the definition on 16 February 2021. G02|G02020

G02|G02021
G02|G02022
G02|G02023
G02|G02024
G02|G02025
G02|G02025|G0202501
G02|G02025|G0202502
G02|G02026
G02|G02027
G02|G02028
G02|G02029
G02|G02030
G02|G02031

G02|G02032

G02|G02033
G02|G02034
G02|G02034|G0203401
G02|G02034|G0203402
G02|G02035

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G02|G02036

G02|G02037
G02|G02038

G02|G02039
G02|G02040
G02|G02040|G0204001
G02|G02040|G0204002
G02|G02040|G0204003
G02|G02040|G0204004
Please use more detailed term within the hierarchy G03
G03|G03001
G03|G03001|G0300101
G03|G03002
G03|G03003
G03|G03004
G03|G03005
Editorial change to the definition on 16 February 2021. G03|G03006
G03|G03007
G03|G03007|G0300701
G03|G03007|G0300702
G03|G03007|G0300703
G03|G03008
G03|G03009
G03|G03010
G03|G03011
G03|G03012
G03|G03012|G0301201
G03|G03012|G0301202
G03|G03012|G0301203
G03|G03012|G0301204
G03|G03012|G0301205
G03|G03012|G0301206
G03|G03013
Term was added on 31 January 2023. For details, see G03|G03014
comment No. 145 of the Change Log (Release Number
2023).
Term was added on 31 January 2023. For details, see G03|G03015
comment No. 146 of the Change Log (Release Number
2023).
Term was added on 31 January 2023. For details, see G03|G03016
comment No. 148 of the Change Log (Release Number
2023).
Please use more detailed term within the hierarchy G04
G04|G04001
G04|G04002
G04|G04003
G04|G04004
G04|G04005

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 AnnexG_NewFormatTerms.csv_Final
Term added for Release Number 2024. See no. 114 of G04|G04005|G0400501
Change Log.
G04|G04006
G04|G04007
G04|G04008
G04|G04009
G04|G04010
G04|G04011
G04|G04012
G04|G04013
G04|G04014
G04|G04015

G04|G04016
G04|G04017
G04|G04018
G04|G04019
G04|G04019|G0401901
G04|G04020
G04|G04021
G04|G04022
G04|G04023
G04|G04023|G0402301
G04|G04024
G04|G04025
G04|G04026
G04|G04027
G04|G04028
G04|G04029
G04|G04030
Term and Definition modified for Release Number 2024. G04|G04030|G0403001
Previous term was Helifix Coil. See no. 113 of Change
Log.
G04|G04031

G04|G04032
G04|G04033
G04|G04034
G04|G04034|G0403401
G04|G04035
G04|G04036
G04|G04037
G04|G04038
G04|G04039
Minor editorial change to the term on 25 June 2020. G04|G04040
G04|G04041
G04|G04042
G04|G04043
G04|G04044
G04|G04045

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 AnnexG_NewFormatTerms.csv_Final
G04|G04046
G04|G04047
G04|G04048
G04|G04049
G04|G04050
G04|G04051
G04|G04052
G04|G04052|G0405201
Editorial change to the definition on 16 February 2021. G04|G04052|G0405202
G04|G04052|G0405203
G04|G04052|G0405204
G04|G04052|G0405205
G04|G04052|G0405206
G04|G04052|G0405207
G04|G04052|G0405208
G04|G04052|G0405209
G04|G04052|G0405210
G04|G04052|G0405211
G04|G04052|G0405212

G04|G04052|G0405213
G04|G04052|G0405214
G04|G04052|G0405215

G04|G04052|G0405216
G04|G04053
G04|G04054
G04|G04055
G04|G04056
G04|G04057
G04|G04058
G04|G04059
G04|G04060
G04|G04061
G04|G04062
G04|G04063
G04|G04064
G04|G04065
G04|G04066
G04|G04067
G04|G04068
G04|G04069
G04|G04070
G04|G04071
G04|G04072
G04|G04073
G04|G04074
G04|G04075
G04|G04076
G04|G04077

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 AnnexG_NewFormatTerms.csv_Final
G04|G04078
G04|G04079
G04|G04080
Term was inactivated on 25 June 2020. Please use G04|G04081
"Cusp/Leaflet" (G04040).
G04|G04082
G04|G04082|G0408201
G04|G04083
G04|G04084
G04|G04085
G04|G04086
G04|G04087
G04|G04088
G04|G04089
G04|G04090
G04|G04091
G04|G04092
G04|G04093
G04|G04094
Editorial change to the definition on 16 February 2021. G04|G04095

G04|G04096
Definition was modified on 31 January 2023 (Old G04|G04097
definition: A thin, flat sheet or strip used to join,
strengthen or to form parts of another structure). For
details, see comment No. 148 of the Change Log
(Release Number 2023).
G04|G04098
G04|G04099
G04|G04100
G04|G04101
G04|G04102
G04|G04103
G04|G04104
G04|G04105
G04|G04106
G04|G04107
G04|G04108
G04|G04108|G0410801
G04|G04109
G04|G04110
G04|G04111
G04|G04112
G04|G04113
G04|G04114
G04|G04115
G04|G04116
G04|G04117
G04|G04118
G04|G04119

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 AnnexG_NewFormatTerms.csv_Final
G04|G04120
G04|G04121
G04|G04122
G04|G04123
G04|G04124
G04|G04125
G04|G04126
G04|G04127
G04|G04128
G04|G04129
Editorial change to the definition on 16 February 2021. G04|G04130

G04|G04131
G04|G04132
G04|G04133
G04|G04134
G04|G04134|G0413401
G04|G04135
G04|G04135|G0413501
G04|G04135|G0413502
G04|G04135|G0413503
G04|G04136
G04|G04137
G04|G04138
G04|G04139
G04|G04140
G04|G04141
G04|G04142
Please use more detailed term within the hierarchy G05
G05|G05001

G05|G05002
G05|G05003
G05|G05004
G05|G05005
G05|G05006
G05|G05007
G05|G05007|G0500701
G05|G05008
G05|G05009
Please use more detailed term within the hierarchy G06
G06|G06001
G06|G06001|G0600101
Editorial change to the definition on 16 February 2021. G06|G06001|G0600102
G06|G06002
G06|G06003
G06|G06004
G06|G06005
G06|G06006

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 AnnexG_NewFormatTerms.csv_Final
Editorial change to the definition on 16 February 2021. G06|G06006|G0600601
G06|G06007
Please use more detailed term within the hierarchy / G07
Definition changed to update a working note on 16 Feb.
2021
G07|G07001

G07|G07002

Term was added on 27 January 2022. For details, see G07|G07003

comment No. 192 of the Change Log (Release Number
2022).

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