Myotrode One With Gel

GUDID D79240602

Non-jelled TENS Electrodes for use with Myomonitor. Designed for patients with sideburns or a beard.

MYOTRONICS NOROMED, INC

Transcutaneous electrical stimulation electrode
Primary Device IDD79240602
NIH Device Record Keya6c66e46-e5a6-4299-8740-8d15c0d55718
Commercial Distribution StatusIn Commercial Distribution
Brand NameMyotrode One With Gel
Version Model Number4060
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
HIBCCD79240602 [Primary]

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

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D79240602 - Myotrode One With Gel2018-07-06Non-jelled TENS Electrodes for use with Myomonitor. Designed for patients with sideburns or a beard.
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 Electrodes2018-07-06 36 single-use electrodes per pouch, 2 pouches per box (72 electrodes total). A revolutionary electrode designed especially for u
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