Home GUDID 00816312025484 Rhythmlink®
Primary DI 00816312025484
Brand Rhythmlink®
Company RHYTHMLINK INTERNATIONAL, LLC
Model 277-930-48TP
Device description Reusable 30 mm Bar Electrode, EMG, 9 mm Concave Tin Discs
Published 2021-08-04
Public version status New
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 JXE Device, Nerve Conduction Velocity Measurement
Product Code Classifications# Code, Device, Specialty table Code Device Specialty Class JXE Device, Nerve Conduction Velocity Measurement Neurology 2
Identifiers And Packaging# Identifier, Type, Agency table Identifier Type Agency Package quantity Status 00816312025484 Primary GS1 0
Alternate GTIN / UPC / EAN Codes Source identifier, GTIN-14 normalized, UPC-A table Source identifier GTIN-14 normalized UPC-A EAN-13 00816312025484 00816312025484 816312025484 0816312025484
GMDN Terms# Term, Definition table Term Definition Analytical non-scalp cutaneous lead 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.
Regulatory Flags# DUNS number 126290993 Device count 1 DM exempt true Premarket exempt false HCT/P false Kit false Combination product false Lot or batch true Serial number false 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# Other Devices Sharing Product Codes# Primary DI, Brand, Company table Primary DI Brand Company Product code Published 00816022023657 DPNCheck IMPULSE MEDICAL TECHNOLOGIES, INC. JXE 2026-01-09 00816022023664 DPNCheck IMPULSE MEDICAL TECHNOLOGIES, INC. JXE 2026-01-09 00816022023671 DPNCheck IMPULSE MEDICAL TECHNOLOGIES, INC. JXE 2026-01-09 00816022023688 DPNCheck IMPULSE MEDICAL TECHNOLOGIES, INC. JXE 2026-01-09 00816022023695 DPNCheck IMPULSE MEDICAL TECHNOLOGIES, INC. JXE 2026-01-09 00816022023701 DPNCheck IMPULSE MEDICAL TECHNOLOGIES, INC. JXE 2026-01-09 00816022023718 DPNCheck IMPULSE MEDICAL TECHNOLOGIES, INC. JXE 2026-01-09 00840067103623 Cadwell Guardian CADWELL INDUSTRIES, INC. JXE 2024-11-15 00840067103609 Cadwell Guiardian CADWELL INDUSTRIES, INC. JXE 2024-03-04 00887868560897 Ultra-Drive® Tool Biomet Orthopedics, LLC JXE 2023-09-07 00887868560903 Ultra-Drive® Tool Biomet Orthopedics, LLC JXE 2023-09-07 00887868560910 Ultra-Drive® Tool Biomet Orthopedics, LLC JXE 2023-09-07 00887868560941 Ultra-Drive® Tool Biomet Orthopedics, LLC JXE 2023-09-07 00887868560958 Ultra-Drive® Tool Biomet Orthopedics, LLC JXE 2023-09-07 00851221006056 DPNCheck 2.0 NeuroMetrix, Inc. JXE 2022-12-20 00851221006575 DPNCheck, China NeuroMetrix, Inc. JXE 2022-12-20 00851221006582 DPNCheck, Japan NeuroMetrix, Inc. JXE 2022-12-20 00887868523687 Ultra-Drive® Tool Biomet Orthopedics, LLC JXE 2021-11-21 00887868523694 Ultra-Drive® Tool Biomet Orthopedics, LLC JXE 2021-11-21 00887868523724 Ultra-Drive® Tool Biomet Orthopedics, LLC JXE 2021-11-21 00887868523731 Ultra-Drive® Biomet Orthopedics, LLC JXE 2021-11-21 00887868523779 Ultra-Drive® Tool Biomet Orthopedics, LLC JXE 2021-11-21 00887868523786 Ultra-Drive® Tool Biomet Orthopedics, LLC JXE 2021-11-21 00887868523809 Ultra-Drive® Tool Biomet Orthopedics, LLC JXE 2021-11-21 00887868523816 Ultra-Drive® Tool Biomet Orthopedics, LLC JXE 2021-11-21 00887868523823 Ultra-Drive® Tool Biomet Orthopedics, LLC JXE 2021-11-21 00816312025477 Rhythmlink® RHYTHMLINK INTERNATIONAL, LLC JXE 2021-08-04 00816312025491 Rhythmlink® RHYTHMLINK INTERNATIONAL, LLC JXE 2021-08-04 00816312025507 Rhythmlink® RHYTHMLINK INTERNATIONAL, LLC JXE 2021-08-04 08056446900642 Galileo NT Line Software EB NEURO SPA JXE 2020-05-25
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