Home GUDID 00860016073418 Evoke EEG System Amplifier
Primary DI 00860016073418
Brand Evoke EEG System Amplifier
Company Firefly Neuroscience, Inc.
Model 2.11
Device description The Evoke EEG System Amplifier is intended to increase signal levels during the acquisition of electrical activity of a patient’s brain.
Published 2026-07-07
Public version status New
Distribution status In Commercial Distribution
MRI safety Labeling does not contain MRI Safety Information
Rx false
OTC false
Sterile false
Single use false Product Codes# Code, Name table Code Name GWJ Stimulator, Auditory, Evoked Response GWQ Full-Montage Standard Electroencephalograph
Product Code Classifications# Code, Device, Specialty table Code Device Specialty Class GWJ Stimulator, Auditory, Evoked Response Neurology 2 GWQ Full-Montage Standard Electroencephalograph Neurology 2
Identifiers And Packaging# Identifier, Type, Agency table Identifier Type Agency Package quantity Status 00860016073418 Primary GS1 0
Alternate GTIN / UPC / EAN Codes Source identifier, GTIN-14 normalized, UPC-A table Source identifier GTIN-14 normalized UPC-A EAN-13 00860016073418 00860016073418 860016073418 0860016073418
GMDN Terms# Term, Definition table Term Definition Electroencephalograph An electrically-powered device designed for noninvasive recording of the electrical activity of the brain for display in the form of a graph [electroencephalogram (EEG)], typically to study a variety of neurological conditions, evaluate psychiatric disorders, and/or assist in localizing tumours or lesions on or near the surface of the brain. It is designed to acquire electrical signals from electrodes typically attached to the scalp and ear lobes. The results may be displayed via print-out or electronically; data interpretation and/or telemetry features may also be included.
Regulatory Flags# DUNS number 145053553 Device count 1 DM exempt false Premarket exempt false HCT/P false Kit false Combination product false Lot or batch false Serial number true Manufacturing date on label true Expiration date on label false Donation ID number false Contains natural rubber latex false No natural rubber latex false Sterilization required before use false Other Devices From This Company# Primary DI, Brand, Model table Primary DI Brand Model Catalog Published 00860016073401 Evoke EEG System 2.11 2026-07-07 00867606000304 eVox System EVO-002-400-000 2021-10-14
Other Devices Sharing Product Codes#