Myotrode SG Solid Gel TENS Electrodes

GUDID D79243003

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.

MYOTRONICS NOROMED, INC

Transcutaneous electrical stimulation electrode Transcutaneous electrical stimulation electrode Transcutaneous electrical stimulation electrode, single-use Transcutaneous electrical stimulation electrode, single-use Transcutaneous electrical stimulation electrode, single-use Transcutaneous electrical stimulation electrode, single-use Transcutaneous electrical stimulation electrode, single-use Transcutaneous electrical stimulation electrode, single-use Transcutaneous electrical stimulation electrode, single-use Transcutaneous electrical stimulation electrode, single-use Transcutaneous electrical stimulation electrode, single-use Transcutaneous electrical stimulation electrode, single-use Transcutaneous electrical stimulation electrode, single-use Transcutaneous electrical stimulation electrode, single-use Transcutaneous electrical stimulation electrode, single-use Transcutaneous electrical stimulation electrode, single-use Transcutaneous electrical stimulation electrode, single-use Transcutaneous electrical stimulation electrode, single-use
Primary Device IDD79243003
NIH Device Record Keybe44822d-8aab-4637-ac8d-50f02e32dbdc
Commercial Distribution StatusIn Commercial Distribution
Brand NameMyotrode SG Solid Gel TENS Electrodes
Version Model Number4300
Company DUNS053824652
Company NameMYOTRONICS NOROMED, INC
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datefalse
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latextrue
RX Perscriptionfalse
OTC Over-The-Counterfalse

Customer Support Contacts

Phone2062434214
Emailinfo@myotronics.com
Phone2062434214
Emailinfo@myotronics.com
Phone2062434214
Emailinfo@myotronics.com
Phone2062434214
Emailinfo@myotronics.com
Phone2062434214
Emailinfo@myotronics.com
Phone2062434214
Emailinfo@myotronics.com
Phone2062434214
Emailinfo@myotronics.com
Phone2062434214
Emailinfo@myotronics.com
Phone2062434214
Emailinfo@myotronics.com
Phone2062434214
Emailinfo@myotronics.com
Phone2062434214
Emailinfo@myotronics.com
Phone2062434214
Emailinfo@myotronics.com
Phone2062434214
Emailinfo@myotronics.com
Phone2062434214
Emailinfo@myotronics.com
Phone2062434214
Emailinfo@myotronics.com
Phone2062434214
Emailinfo@myotronics.com
Phone2062434214
Emailinfo@myotronics.com
Phone2062434214
Emailinfo@myotronics.com

Device Identifiers

Device Issuing AgencyDevice ID
HIBCCD79243001 [Primary]
HIBCCD79243002 [Package]
Contains: D79243001
Package: Box [2 Units]
In Commercial Distribution
HIBCCD79243003 [Package]
Contains: D79243001
Package: Case [20 Units]
In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

NUWStimulator, Muscle, Powered, Dental

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number3
Public Version Date2018-07-06
Device Publish Date2016-09-19

Devices Manufactured by MYOTRONICS NOROMED, INC

D79244500 - J5 Myo-Monitor2019-10-23 The J5 Myomonitor TENS unit is a muscle stimulator used to create a physiologically relaxed state of the muscles of mastication.
D79245000 - BNS-40 Home Treatment Unit2019-10-23 The BNS-40 is a miniaturized version of the Myomonitor designed to allow the patient to safely apply electrical stimulation whil
D79209830 - K7 ESG-2 Electrosonograph2018-07-06 TMJ Vibration (Sound) Evaluation System. A lightweight headset holds highly sensitive vibration transducers over each TM joint,
D79240602 - Myotrode One With Gel2018-07-06 Non-jelled TENS Electrodes for use with Myomonitor. Designed for patients with sideburns or a beard.
D79240702 - Myotrode One without Gel2018-07-06 Non-jelled TENS Electrodes for use with Myomonitor.Designed for patients with sideburns or a beard.
D79243003 - Myotrode SG Solid Gel TENS Electrodes2018-07-0636 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.
D79243003 - Myotrode SG Solid Gel TENS Electrodes2018-07-06 36 single-use electrodes per pouch, 2 pouches per box (72 electrodes total). A revolutionary electrode designed especially for u
D792N12013 - Norotrode 202018-07-06 NOROTRODES are silver-silver chloride electrodes for surface EMG applications. Contact surfaces pre-jelled with hypoallergenic
D792N150MES0 - MES 9000 Static Electromyography Scanner2018-07-06 Noromed SEMG, with broader operating ranges, greater sensitivity, and unsurpassed ability to eliminate extraneous electrical "no
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