Myoguide System Model 8008

Primary DI
00627843471783
Brand
Myoguide System Model 8008
Company
Intronix Technologies Corporation
Model
8008
Catalog number
8008
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.
Published
2016-09-23
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Product Codes#

Code, Name table
CodeName
BXNStimulator, Nerve, Battery-Powered

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
BXNStimulator, Nerve, Battery-PoweredAnesthesiology2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00627843471783PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00627843471783006278434717836278434717830627843471783

GMDN Terms#

Term, Definition table
TermDefinition
Intramuscular injection site nerve-locating/electromyography systemA 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.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
249192931
Device count
1
Premarket exempt
true
Serial number
true
Manufacturing date on label
true

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