FDA.report

Subdermal needle electrode

Definition
A sterile, multi-purpose electrical conductor inserted beneath the dermal layer of a patient's skin to record/monitor electrical activity (biopotentials) for physiological measurements [typically electroencephalography (EEG), electromyography (EMG), and evoked-potential) and often to provide electrical stimulation. It typically consists of thin shaft of stainless steel connected to a lead wire that terminates with a safety connector for attachment to recording/monitoring and stimulation systems. This is a single-use device.
GUDID devices
913
Last updated
2025-12-18 15:34:06

Related Product Codes

CodeDeviceSpecialtyClassDevices
GXZElectrode, NeedleNeurology2596
GWFStimulator, Electrical, Evoked ResponseNeurology2111
IKTElectrode, Needle, Diagnostic ElectromyographPhysical Medicine288
GZLElectrode, DepthNeurology249
IKNElectromyograph, DiagnosticPhysical Medicine219
GXYElectrode, CutaneousNeurology216
GYCElectrode, CorticalNeurology212
ETNStimulator, NerveEar, Nose, Throat26
FMINeedle, Hypodermic, Single LumenGeneral Hospital23
GWQFull-Montage Standard ElectroencephalographNeurology23
GAANeedle, Aspiration And Injection, DisposableGeneral, Plastic Surgery12
ITXTransducer, Ultrasonic, DiagnosticRadiology22
IYNSystem, Imaging, Pulsed Doppler, UltrasonicRadiology22
EWOAudiometerEar, Nose, Throat21
GWJStimulator, Auditory, Evoked ResponseNeurology21
HAWNeurological Stereotaxic InstrumentNeurology21
MDMInstrument, Manual, Surgical, General UseGeneral, Plastic Surgery11

Representative GUDID Devices

Primary DIBrandCompanyModelPublished
08720791378530CadwellTechnomed Engineering B.V.302882-0002025-12-10
10816312027850Rhythmlink®RHYTHMLINK INTERNATIONAL, LLCCTGN2121-2.52025-12-05
10816312027867Rhythmlink®RHYTHMLINK INTERNATIONAL, LLCCTGN2121-2.52025-12-03
00816312027365Rhythmlink®RHYTHMLINK INTERNATIONAL, LLCGNFD5152025-07-30
00816312027372Rhythmlink®RHYTHMLINK INTERNATIONAL, LLCGNFD51522025-07-30
08720791378011CadwellTechnomed Engineering B.V.302862-000-GP22025-07-16
08720791378035CadwellTechnomed Engineering B.V.302864-000-GP22025-07-15
20763000886794N/aMEDTRONIC XOMED, INC.96263402025-06-23
00816312027709Rhythmlink®RHYTHMLINK INTERNATIONAL, LLCRLSP5522025-05-16
00816312027716Rhythmlink®RHYTHMLINK INTERNATIONAL, LLCRLSP5532025-05-16
00816312027723Rhythmlink®RHYTHMLINK INTERNATIONAL, LLCRLSP5542025-05-16
00816312027730Rhythmlink®RHYTHMLINK INTERNATIONAL, LLCRLSP5552025-05-16
00816312027747Rhythmlink®RHYTHMLINK INTERNATIONAL, LLCRLSP5562025-05-16
10816312027652Rhythmlink®RHYTHMLINK INTERNATIONAL, LLCRLSND801-2.52025-05-05
10816312027669Rhythmlink®RHYTHMLINK INTERNATIONAL, LLCRLSND802-2.52025-05-05
10816312027515Rhythmlink®RHYTHMLINK INTERNATIONAL, LLCCTGN2121-1.52025-02-26
08718375861455Technomed EuropeTechnomed Engineering B.V.TE/S50716-0012016-09-22
08718375861462Technomed EuropeTechnomed Engineering B.V.TE/S50716-0022016-09-22
08718375861479Technomed EuropeTechnomed Engineering B.V.TE/S50716-0032016-09-22
08718375861486Technomed EuropeTechnomed Engineering B.V.TE/S50716-0042016-09-22
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08718375861509Technomed EuropeTechnomed Engineering B.V.TE/S43-6382016-09-22
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08718375861554Technomed EuropeTechnomed Engineering B.V.TE/S45-6382016-09-22
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08718375861578Technomed EuropeTechnomed Engineering B.V.TE/S50719-0012016-09-22
08718375861585Technomed EuropeTechnomed Engineering B.V.TE/S50719-0022016-09-22
08718375861592Technomed EuropeTechnomed Engineering B.V.TE/S50719-0032016-09-22
08718375861608Technomed EuropeTechnomed Engineering B.V.TE/S50718-0012016-09-22
08718375861615Technomed EuropeTechnomed Engineering B.V.TE/S50718-0022016-09-22
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08718375861684Technomed EuropeTechnomed Engineering B.V.TE/S50715-0022016-09-22
08718375861691Technomed EuropeTechnomed Engineering B.V.TE/S50715-0032016-09-22
08718375862513Technomed EuropeTechnomed Engineering B.V.TE/S50721-0012016-09-22
08718375862520Technomed EuropeTechnomed Engineering B.V.TE/S50721-0022016-09-22
08718375862537Technomed EuropeTechnomed Engineering B.V.TE/S50721-0032016-09-22
08718375862544Technomed EuropeTechnomed Engineering B.V.TE/S50721-0042016-09-22
08718375862551Technomed EuropeTechnomed Engineering B.V.TE/S22-8372016-09-22
08718375862568Technomed EuropeTechnomed Engineering B.V.TE/S43-438/022016-09-22
08718375862575Technomed EuropeTechnomed Engineering B.V.TE/S44-9372016-09-22
08718375863510Technomed EuropeTechnomed Engineering B.V.TE/S42-9372016-09-26
08718375863572Technomed EuropeTechnomed Engineering B.V.TE/S49-4382017-07-04
08718375863589Technomed EuropeTechnomed Engineering B.V.TE/S49-6382017-07-04
08718375863596Technomed EuropeTechnomed Engineering B.V.TE/S49-8382017-07-04
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08720791375232Technomed EuropeTechnomed Engineering B.V.TE/S50715-0012025-01-07
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08720791375317Technomed EuropeTechnomed Engineering B.V.TE/S50715-0032025-01-07
08720791375331Technomed EuropeTechnomed Engineering B.V.TE/S50715-003-C2025-01-07
08720791375393Technomed EuropeTechnomed Engineering B.V.TE/S50725-0012025-01-07
08720791375416Technomed EuropeTechnomed Engineering B.V.TE/S50725-001-C2025-01-07
08720791375478Technomed EuropeTechnomed Engineering B.V.TE/S50725-0032025-01-07
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08720791377625CadwellTechnomed Engineering B.V.202307-000-GP2 2024-11-25
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08720791376536CadwellTechnomed Engineering B.V.302888-0002024-11-18
08720791376550CadwellTechnomed Engineering B.V.302888-000-GP22024-11-18
08720791376574CadwellTechnomed Engineering B.V.302860-000-GP22024-11-18
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