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Myoguide System Model 8008

FDA UDI

Class II (US FDA UDI)

by Intronix Technologies Corp.

Identity

Trade Name
Myoguide System Model 8008 FDA UDI
Generic Name
Intramuscular injection site nerve-locating/electromyography system FDA UDI
Device Name
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. FDA UDI
Model / Reference
8008 FDA UDI
Description
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. FDA UDI

Identifiers

Catalog Number
8008 FDA UDI
Primary DI / UDI-DI
00627843471783 FDA UDI
FDA Product Code
BXN FDA UDI
GMDN Term
Intramuscular injection site nerve-locating/electromyography system FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
868.2775 FDA UDI
Commercial Distribution
In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

No

FDA UDI

Single Use

No

FDA UDI

Implantable

No

FDA UDI

Contains Latex

No

FDA UDI

Prescription Use

Yes

FDA UDI

Over-the-Counter

No

FDA UDI

Convenience Kit

No

FDA UDI

Combination Product

No

FDA UDI

HCT/P

No

FDA UDI

Premarket Exempt

Yes

FDA UDI

Lot / Batch Number

No

FDA UDI

Serial Number

Yes

FDA UDI

Expiration Date

No

FDA UDI

Manufacturing Date

Yes

FDA UDI

Category: Intramuscular injection site nerve-locating/electromyography system

Myoguide System Model 8008 by Intronix Technologies Corp. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Intramuscular injection site nerve-locating/electromyography system.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Intronix Technologies Corp.

Sources (1)

  • FDA UDI 3bad2fb4-30b6-4a63-bccc-9b6b8455dcf2 34 fields · synced May 30, 2026