Home GUDID 00816312020847 Rhythmlink®
Primary DI 00816312020847
Brand Rhythmlink®
Company RHYTHMLINK INTERNATIONAL, LLC
Model RLMSP101-2.5
Device description Extended Monopolar Stimulating Probe
Published 2016-09-17
Public version status Update
Distribution status In Commercial Distribution
MRI safety Labeling does not contain MRI Safety Information
Rx true
OTC false
Sterile true
Single use true Product Codes# Code, Name table Code Name ETN Stimulator, Nerve
Product Code Classifications# Code, Device, Specialty table Code Device Specialty Class ETN Stimulator, Nerve Ear, Nose, Throat 2
Identifiers And Packaging# Identifier, Type, Agency table Identifier Type Agency Package quantity Status 00816312020847 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 00816312020847 00816312020847 816312020847 0816312020847
GMDN Terms# Term, Definition table Term Definition Diagnostic peripheral nerve electrical stimulation system An assembly of devices designed to apply electrical stimuli in one peripheral region of the body while the response is monitored in another peripheral region. It typically consists of external electrodes (e.g., hand-held bipolar or ring electrodes) or needle electrodes and a pulse generator. It is used for the stimulation of a peripheral nerve or muscle in motor-nerve conduction studies (e.g., the posterior tibial nerve), and/or in sensory-nerve conduction studies (e.g., the ulnar nerve) performed during clinical electrophysiology (EP) assessments.
Regulatory Flags# DUNS number 126290993 Device count 1 DM exempt false Premarket exempt false HCT/P false Kit false Combination product false Lot or batch true Serial number false Manufacturing date on label false Expiration date on label true 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 10860013827103 Evala nerve stimulator Epineuron Technologies Inc. ETN 2026-03-17 00199150023851 N/A MEDTRONIC XOMED, INC. ETN 2026-02-16 00199150023868 N/A MEDTRONIC XOMED, INC. ETN 2026-02-16 00199150023875 N/A MEDTRONIC XOMED, INC. ETN 2026-02-16 00199150023882 N/A MEDTRONIC XOMED, INC. ETN 2026-02-16 00840067103029 Zenith CADWELL INDUSTRIES, INC. ETN 2025-12-31 00810155862664 NONE Neurovision Medical Products, Inc. ETN 2025-12-19 00810155862688 NONE Neurovision Medical Products, Inc. ETN 2025-12-19 08720791377717 Inomed Technomed Engineering B.V. ETN 2025-12-10 08720791377724 Inomed Technomed Engineering B.V. ETN 2025-12-10 08720791377731 Inomed Technomed Engineering B.V. ETN 2025-12-10 00643169547087 NIM® MEDTRONIC XOMED, INC. ETN 2025-09-13 00763000831479 NIM™ MEDTRONIC XOMED, INC. ETN 2025-08-11 20763000831480 NIM™ MEDTRONIC XOMED, INC. ETN 2025-08-11 20763000831497 NIM™ MEDTRONIC XOMED, INC. ETN 2025-08-11 14250307612076 N/A inomed Medizintechnik GmbH ETN 2025-05-02 14250307612083 N/A inomed Medizintechnik GmbH ETN 2025-05-02 00816312027570 Rhythmlink® RHYTHMLINK INTERNATIONAL, LLC ETN 2025-03-21 B066HGELS1 NONE NEUROVISION MEDICAL PRODUCTS, INC. ETN 2025-02-12 B006IJCBFB60 NONE NEUROVISION MEDICAL PRODUCTS, INC. ETN 2025-02-12 00763000835330 NIM Neuro MEDTRONIC XOMED, INC. ETN 2025-01-23 00190376530024 SafeOp 3 ALPHATEC SPINE, INC. ETN 2024-11-12 00763000842543 Bipolar Stimulating Probe MEDTRONIC XOMED, INC. ETN 2024-10-26 00763000842550 Bipolar Stimulating Probe MEDTRONIC XOMED, INC. ETN 2024-10-26 00763000842567 Bipolar Stimulating Probe MEDTRONIC XOMED, INC. ETN 2024-10-26 00763000891862 ENT NIM Electrode MEDTRONIC XOMED, INC. ETN 2024-09-23 00763000891879 ENT NIM Electrode MEDTRONIC XOMED, INC. ETN 2024-09-23 00763000580483 ENT NIM Vital MEDTRONIC XOMED, INC. ETN 2024-09-19 00763000576769 N/A MEDTRONIC XOMED, INC. ETN 2024-09-14 00763000576776 N/A MEDTRONIC XOMED, INC. ETN 2024-09-14
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