Home GUDID D79243003 Myotrode SG Solid Gel TENS Electrodes
Primary DI D79243003
Brand Myotrode SG Solid Gel TENS Electrodes
Company MYOTRONICS NOROMED, INC
Model 4300
Device description 36 single-use electrodes per pouch, 2 pouches per box (72 electrodes total). A revolutionary electrode designed especially for use with the Myomonitor and BNS-40 unit.
Published 2016-09-19
Public version status Update
Distribution status In Commercial Distribution
MRI safety Labeling does not contain MRI Safety Information
Rx false
OTC false
Sterile false
Single use true Product Codes# Code, Name table Code Name NUW Stimulator, Muscle, Powered, Dental
Product Code Classifications# Code, Device, Specialty table Code Device Specialty Class NUW Stimulator, Muscle, Powered, Dental Physical Medicine 2
Identifiers And Packaging# Identifier, Type, Agency table Identifier Type Agency Package quantity Status D79243002 Package HIBCC 2 In Commercial Distribution D79243003 Package HIBCC 20 In Commercial Distribution D79243001 Primary HIBCC 0
GMDN Terms# Term, Definition table Term Definition Transcutaneous electrical stimulation electrode A non-sterile electrical conductor intended to be attached to a patient's skin (noninvasive) to provide therapeutic electrical stimuli through the body surface [e.g., transcutaneous electrical nerve stimulation (TENS), electrical muscle stimulation, cranial electrotherapy stimulation (CES)]. It is typically a flat, flexible, conductive pad with an adhesive (e.g., gel), or a preformed shape/mechanism designed for attachment to a particular body part (e.g., earclip), connected to a conductive 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 053824652 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 true Sterilization required before use false Other Devices From This Company# Primary DI, Brand, Model table Primary DI Brand Model Catalog Published D79261451 Myotronics 6145 Duotrodes 6145 2016-09-19 D792N12011 Norotrode 20 N120 2016-09-19 D7921013 Monotrode 101 101 2016-09-19 D792N36010 Noromed NT-360 Inclinometer NT360 2017-02-11 D792N9000M0 MES 9000 Musculoskeletal System N9000M 2016-09-19 D792N9200A0 MES 9000 Dynamic EMG MES 9000 EMG 2017-02-11 D792N9600A0 MES 9000 Muscle Tester Muscle Tester 2016-09-19 D79243001 Myotrode SG Solid Gel TENS Electrodes 4300 2016-09-19 D79240602 Myotrode One With Gel 4060 2016-09-19 D79240702 Myotrode One without Gel 4070 2016-09-19 D79244500 J5 Myo-Monitor J5 4450 2016-08-18 D79245000 BNS-40 Home Treatment Unit BNS-40 4500 2016-08-18 D79209830 K7 ESG-2 Electrosonograph ESG-2 0983 2016-08-18 D792N12013 Norotrode 20 N120 2016-09-19 D792N150MES0 MES 9000 Static Electromyography Scanner Static EMG Scanner 2016-09-19 D792N91500 MES 9000 Musculoskeletal System N9000M 2016-09-19 D79209750 K7 Evaluation System-ESG K7/ESG 2016-09-19 D79209930 K7 Evaluation System-EMG K7/EMG 2016-09-19 D0792009780 K7 Evaluation System-ESG K7/ESG 2016-09-19 D07920978 K7 Evaluation System-EMG K7/EMG 2016-09-19
Other Devices Sharing Product Codes# Primary DI, Brand, Company table Primary DI Brand Company Product code Published B108785APMMUS10 EMFACE controller BTL INDUSTRIES LIMITED NUW 2023-06-28 04983087012394 D function ITO CO., LTD. NUW 2021-09-09 D79243001 Myotrode SG Solid Gel TENS Electrodes MYOTRONICS NOROMED, INC NUW 2016-09-19 D7921013 Monotrode 101 MYOTRONICS NOROMED, INC NUW 2016-09-19 D79240602 Myotrode One With Gel MYOTRONICS NOROMED, INC NUW 2016-09-19 D79240702 Myotrode One without Gel MYOTRONICS NOROMED, INC NUW 2016-09-19 D79244500 J5 Myo-Monitor MYOTRONICS NOROMED, INC NUW 2016-08-18 D79245000 BNS-40 Home Treatment Unit MYOTRONICS NOROMED, INC NUW 2016-08-18
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