Myoguide System Model 8008 8008

GUDID 00627843471783

The Intronix Model 8008 Myoguide system (Myoguide) is a medical device that operates as an electromyography (EMG) amplifier with onboard stimulator and signal display. It is intended for use to amplify muscle signals (EMG) from muscle and provide audio and visual feedback to assist clinicians in locating areas of muscle activity. The stimulator can be used for nerve localization or to invoke a muscle twitch. These features provide feedback used for guidance of injections into muscle or in the vicinity of nerves. This device is a battery powered, handheld, EMG amplifier with audio feedback and stimulator, LCD EMG signal and device status display, and current stimulation ranging from 0 mA - 20 mA.

Intronix Technologies Corporation

Intramuscular injection site nerve-locating/electromyography system
Primary Device ID00627843471783
NIH Device Record Key3bad2fb4-30b6-4a63-bccc-9b6b8455dcf2
Commercial Distribution StatusIn Commercial Distribution
Brand NameMyoguide System Model 8008
Version Model Number8008
Catalog Number8008
Company DUNS249192931
Company NameIntronix Technologies Corporation
Device Count1
DM Exemptfalse
Pre-market Exempttrue
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usefalse
Lot Batchfalse
Serial Numbertrue
Manufacturing Datetrue
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS100627843471783 [Primary]

FDA Product Code

BXNStimulator, Nerve, Battery-Powered

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number3
Public Version Date2018-04-25
Device Publish Date2016-09-23

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.