FDA.reportPublic FDA data

Analytical non-scalp cutaneous lead

Definition
An insulated metal wire(s) designed to conduct electrical signals between a skin electrode(s) or needle electrode(s) [electrode not included] and a device designed for electrophysiological recording/monitoring [e.g., electromyography (EMG), evoked potentials (EP), bioelectrical impedance]. It is not primarily intended for diagnostic electrocardiography (ECG) or electroencephalography (EEG). This is a reusable device.
GUDID devices
250
Last updated
2023-12-11 20:29:24

Representative GUDID Devices#

Primary DI, Brand, Company table
Primary DIBrandCompanyModelPublished
08720791372958CadwellTechnomed Engineering B.V.202276-0002023-12-01
08720791372965CadwellTechnomed Engineering B.V.202277-0002023-12-01
08720791370626NeuroguardTechnomed Engineering B.V.Q95-9312023-01-02
08718375866108Technomed EuropeTechnomed Engineering B.V.TE/Q95-9312018-12-10
08718375866115Technomed EuropeTechnomed Engineering B.V.675.705S2017-06-28
00850015266836X-Series, X8ADVANCED BRAIN MONITORING, INC.SP29-4001.LE(POL)2023-04-06
00850015266805X-Series, X8ADVANCED BRAIN MONITORING, INC.UN03-4008(POL)2023-04-05
05711117095913Sanibel Supply A/SInteracoustics A/SPinch clip cables, BRW2022-11-30
05711117095920Sanibel Supply A/SInteracoustics A/SPinch clip cables, WKY2022-11-30
05711117095937Sanibel Supply A/SInteracoustics A/SPinch clip cables, BRWKY2022-11-30
05711117199987Sanibel Supply A/SInteracoustics A/SAlligator clip cable, WYK2022-11-30
05711117218121Sanibel Supply A/SInteracoustics A/SAlligator clip cable, RWB2022-11-30
05711117218145Sanibel Supply A/SInteracoustics A/SAlligator clip cable, RWBYK2022-11-30
05711117219012Sanibel Supply A/SInteracoustics A/SPinch clip electrode cables, WYK2022-11-30
05711117227406Sanibel Supply A/SInteracoustics A/SButton electrode cable, RWB2022-11-30
05711117227413Sanibel Supply A/SInteracoustics A/SButton electrode cable, RWBYK2022-11-30
05711117019025Sanibel Supply A/SInteracoustics A/SETB standard electrode cable2022-11-29
05711117019100Sanibel Supply A/SInteracoustics A/SETB titan standard electrode cable2022-11-29
05711117105414Sanibel Supply A/SInteracoustics A/SCable for TM ECochG electrode2022-11-29
05711117131086Sanibel Supply A/SInteracoustics A/SJumper Cable 2022-11-29
00850015266553X-Series, X8ADVANCED BRAIN MONITORING, INC.UN03-40082022-11-15
00850015266560X-Series, X8ADVANCED BRAIN MONITORING, INC.SP29-4001.LE2022-11-15
00850015266577X-Series, X8ADVANCED BRAIN MONITORING, INC.SP29-4001.LE(ITA)2022-11-15
00850015266584X-Series, X8ADVANCED BRAIN MONITORING, INC.UN03-4008(ITA)2022-11-15
00627825014540Urostym EMG Stimulation Cable, Ch 1Laborie Medical Technologies Corp.CAB8962022-11-10
00627825014557Urostym EMG Cable, Ch 2Laborie Medical Technologies Corp.CAB9062022-11-10
00627825014564Goby EMG Cable Extension, Non-shieldedLaborie Medical Technologies Corp.CAB1432022-11-10
00627825014571NGM EMG Cable, Non-shielded, ShortLaborie Medical Technologies Corp.CAB10322022-11-10
00627825014588NGM EMG Cable, Non-shielded, LongLaborie Medical Technologies Corp.CAB10342022-11-10
00627825014595NGM EMG Cable, Shielded, ShortLaborie Medical Technologies Corp.CAB10332022-11-10
00627825014601EMG Shorting Leads, ShieldedLaborie Medical Technologies Corp.CAB1502022-11-10
00627825014618NGM EMG Cable, Shielded, LongLaborie Medical Technologies Corp.CAB10352022-11-10
00627825014809NXT EMG cable, Long, 1-channel Laborie Medical Technologies Corp.CAB10922022-11-10
00627825014816NXT EMG cable, Short, 1-channel Laborie Medical Technologies Corp.CAB10912022-11-10
00846430005396EtymoticETYMOTIC RESEARCH, INC.ER3-60A2022-01-19
18054655000402Connection cableSPES MEDICA SPA2001PUD7126SH2021-12-22
00382830000154NatusXLTEKW6233H2021-10-26
00382830043809NatusNATUS NEUROLOGY INCORPORATED085-4624012021-10-26
00382830000130NatusXLTEKW6348H2021-10-08
00382830000147NatusXLTEKW6232H2021-10-08
08718375868249TeDan Surgical InnovationsTechnomed Engineering B.V.ML-04452021-09-24
00382830043342NatusNATUS NEUROLOGY INCORPORATEDCB01022021-09-14
00382830058230NatusNATUS NEUROLOGY INCORPORATED2002-TP2021-09-14
00382830058247NatusNATUS NEUROLOGY INCORPORATED085-4174012021-09-14
00816312025354Rhythmlink®RHYTHMLINK INTERNATIONAL, LLC263-9P-24BTP2021-08-04
00816312025361Rhythmlink®RHYTHMLINK INTERNATIONAL, LLC263-9P-24RTP2021-08-04
00816312025378Rhythmlink®RHYTHMLINK INTERNATIONAL, LLC264-9P-24TP2021-08-04
00816312025385Rhythmlink®RHYTHMLINK INTERNATIONAL, LLC264-9P-36STP2021-08-04
00816312025392Rhythmlink®RHYTHMLINK INTERNATIONAL, LLC265-9G-24BTP2021-08-04
00816312025408Rhythmlink®RHYTHMLINK INTERNATIONAL, LLC265-9G-24RTP2021-08-04
00816312025415Rhythmlink®RHYTHMLINK INTERNATIONAL, LLC265-9S-24BTP2021-08-04
00816312025422Rhythmlink®RHYTHMLINK INTERNATIONAL, LLC265-9S-24RTP2021-08-04
00816312025439Rhythmlink®RHYTHMLINK INTERNATIONAL, LLC266-9G-24TP2021-08-04
00816312025446Rhythmlink®RHYTHMLINK INTERNATIONAL, LLC266-9S-24TP2021-08-04
00816312025453Rhythmlink®RHYTHMLINK INTERNATIONAL, LLC266-9G-36STP2021-08-04
00816312025460Rhythmlink®RHYTHMLINK INTERNATIONAL, LLC266-9S-36STP2021-08-04
00816312025477Rhythmlink®RHYTHMLINK INTERNATIONAL, LLC277-930-24TP2021-08-04
00816312025484Rhythmlink®RHYTHMLINK INTERNATIONAL, LLC277-930-48TP2021-08-04
00816312025491Rhythmlink®RHYTHMLINK INTERNATIONAL, LLC277-930-36STP2021-08-04
00816312025507Rhythmlink®RHYTHMLINK INTERNATIONAL, LLC279-930-24TP2021-08-04
00816312025514Rhythmlink®RHYTHMLINK INTERNATIONAL, LLC285-32-24TP2021-08-04
00816312025521Rhythmlink®RHYTHMLINK INTERNATIONAL, LLC285-32-48TP2021-08-04
00816312025538Rhythmlink®RHYTHMLINK INTERNATIONAL, LLC293-2-24TP2021-08-04
00816312025545Rhythmlink®RHYTHMLINK INTERNATIONAL, LLC293-2-48TP2021-08-04
00816312025552Rhythmlink®RHYTHMLINK INTERNATIONAL, LLC293-2-36STP2021-08-04
00816312025569Rhythmlink®RHYTHMLINK INTERNATIONAL, LLC293-2SL-24TP2021-08-04
00816312025576Rhythmlink®RHYTHMLINK INTERNATIONAL, LLC293-2SL-48TP2021-08-04
00816312025583Rhythmlink®RHYTHMLINK INTERNATIONAL, LLC295-2-24TP2021-08-04
00816312025590Rhythmlink®RHYTHMLINK INTERNATIONAL, LLC295-2-48TP2021-08-04
00816312025606Rhythmlink®RHYTHMLINK INTERNATIONAL, LLC295-2-36STP2021-08-04
08718375868089NatusTechnomed Engineering B.V.085-4447002021-05-11
08718375862988Technomed EuropeTechnomed Engineering B.V.TE/S81-434/012016-09-22
08718375864418Technomed EuropeTechnomed Engineering B.V.TE/50441-0012018-09-26
08718375860052Biosense WebsterTechnomed Engineering B.V.C6FFMST102018-08-15
08718375860120Biosense WebsterTechnomed Engineering B.V.C3MRMST4SA2018-08-15
08718375860137Biosense WebsterTechnomed Engineering B.V.C3MRMST6SA2018-08-15
08718375860144Biosense WebsterTechnomed Engineering B.V.C3MRMST8SA2018-08-15
08718375860151Biosense WebsterTechnomed Engineering B.V.C3MRMST10SA2018-08-15
08718375860168Biosense WebsterTechnomed Engineering B.V.C6MRMST10SA2018-08-15
08718375860175Biosense WebsterTechnomed Engineering B.V.C6MRMST4SA2018-08-15