Home GUDID E10001 ControlSeal Electrode Domes (Standard Size)
Primary DI E10001
Brand ControlSeal Electrode Domes (Standard Size)
Company COAPT LLC
Model 1
Device description Non-invasive, cutaneous electrode for use with recording and monitoring equipment of Electromyography (EMG).
Published 2023-01-09
Public version status Update
Distribution status In Commercial Distribution
MRI safety Labeling does not contain MRI Safety Information
Rx true
OTC false
Sterile false
Single use false Product Codes# Code, Name table Code Name GXY Electrode, Cutaneous
Product Code Classifications# Code, Device, Specialty table Code Device Specialty Class GXY Electrode, Cutaneous Neurology 2
Identifiers And Packaging# Identifier, Type, Agency table Identifier Type Agency Package quantity Status B618E1 Primary HIBCC 0 B618E2 Primary HIBCC 0 E10001 Unit of Use HIBCC 0
GMDN Terms# Term, Definition table Term Definition Analytical non-scalp cutaneous electrode An electrical conductor designed to be attached to the skin surface of a patient outside of the hair line (i.e., non-scalp) to conduct electrical signals to/from a parent device for electrophysiological recording/monitoring [e.g., electromyography (EMG), evoked potentials (EP), nerve conduction study (NCS), bioelectrical impedance]; it is not primarily intended for diagnostic electrocardiography (ECG) or electroencephalography (EEG). It typically consists of a small rectangular tab or cup/disk with a conductive surface, which may include a lead wire. This is a single-patient device that may be reapplied to the patient over a short term (single-use) before being discarded.
Regulatory Flags# DUNS number 078505297 Device count 9 DM exempt false Premarket exempt false HCT/P false Kit false Combination product false Lot or batch false Serial number true Manufacturing date on label true Expiration date on label false Donation ID number false Contains natural rubber latex false No natural rubber latex false Sterilization required before use false Other Devices From This Company# Primary DI, Brand, Model table Primary DI Brand Model Catalog Published B618P1 Gen2 System Kit 1 2019-06-19 B618N1 COMPLETE CONTROL System Gen2 1 2019-06-12 B618A0 Complete Controller 1 CC110 2018-05-08 B618B0 Complete Communicator 1 2018-05-08 B618C0 Complete Co-Amp 1 2018-05-08 B618D0 Complete Calibrate 1 2018-05-08 B618E1 ControlSeal Electrode Domes (Standard Size) 1 2023-01-09 B618E2 ControlSeal Electrode Domes (Standard Size) 1 2023-01-09 B618E4 ControlSeal Electrode Domes (Standard Size) 1 2023-02-20 B618E5 ControlSeal Electrode Domes (Large Size) 1 2023-02-20 B618E3 ControlSeal Electrode Domes (Large Size) 1 2023-01-09 B618E0 Dome Electrodes 1 2019-04-15 E40001 ControlSeal Electrode Domes (Standard Size) 1 2023-02-20 E50001 ControlSeal Electrode Domes (Large Size) 1 2023-02-20 B618Q1 Coapt Evaluation Kit 1 2019-11-18
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