Myoguide System Model 8008

Basic Information

• Brand Name: Myoguide System Model 8008
• Primary DI: 00627843471783
• Version / Model: 8008
• Catalog Number: 8008
• Company Name: Intronix Technologies Corporation
• Labeler DUNS: 249192931
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2016-09-23
• Public Version: 3
• Public Version Date: 2018-04-25
• Public Version Status: Update
• Public Device Record Key: 3bad2fb4-30b6-4a63-bccc-9b6b8455dcf2

Device 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.

Device Characteristics

• Single Use: No
• Prescription Use (Rx): Yes
• Over the Counter (OTC): No
• Kit: No
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: No
• MRI Safety: Labeling does not contain MRI Safety Information
• Direct Marking Exempt: No
• PM Exempt: Yes
• Has Serial Number: Yes
• Has Lot/Batch Number: No
• Has Manufacturing Date: Yes
• Has Expiration Date: No
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
BXN	Stimulator, Nerve, Battery-Powered	Anesthesiology	868.2775	2

GMDN Terms

Code	Name	Definition	Implantable	Status
62216	Intramuscular injection site nerve-locating/electromyography system	A portable, electrically-powered device intended to produce electrical impulses for electrical nerve stimulation and to obtain and display electromyography (EMG) readings (visual and/or audio) to locate nerves and muscle, to facilitate accurate intramuscular injection of neuromodulator drugs. It is typically used in multi-focal areas (e.g., neck, hand), and consists of an electrical stimulator with EMG reader in a noninvasive unit (electrodes not included) which typically includes input cables and connectors.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00627843471783	GS1