Home GUDID 05391540580028 Lenire
Primary DI 05391540580028
Brand Lenire
Company NEUROMOD DEVICES LIMITED
Model CR-201
Device description Lenire Tinnitus Treatment Device
Published 2023-05-19
Public version status New
Distribution status In Commercial Distribution
MRI safety Labeling does not contain MRI Safety Information
Rx true
OTC false
Sterile false
Single use false Product Codes# Code, Name table Code Name QVN Combined Acoustic And Electrical External Stimulation Device For The Relief Of Tinnitus
Product Code Classifications# Code, Device, Specialty table Code Device Specialty Class QVN Combined Acoustic And Electrical External Stimulation Device For The Relief Of Tinnitus Ear, Nose, Throat 2
Identifiers And Packaging# Identifier, Type, Agency table Identifier Type Agency Package quantity Status 05391540580028 Primary GS1 0
Alternate GTIN / UPC / EAN Codes Source identifier, GTIN-14 normalized, EAN-13 table Source identifier GTIN-14 normalized EAN-13 05391540580028 05391540580028 5391540580028
GMDN Terms# Term, Definition table Term Definition Tinnitus therapy auditory/translingual electrical stimulation system An electrically-powered assembly of devices designed to treat tinnitus through bimodal neuromodulation of the brain, involving simultaneous application of electrical pulses to the tongue and delivery of specific sounds to the auditory system. It includes a system generator and a tongue applicator with integrated electrodes; it is intended to be used with headphones which might be included.
Regulatory Flags# DUNS number 985051113 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# Other Devices Sharing Product Codes#