Home GUDID 05391540580011 Lenire
Primary DI 05391540580011
Brand Lenire
Company NEUROMOD DEVICES LIMITED
Model TP-101
Device description Lenire Tonguetip
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 05391540580011 Primary GS1 0
Alternate GTIN / UPC / EAN Codes Source identifier, GTIN-14 normalized, EAN-13 table Source identifier GTIN-14 normalized EAN-13 05391540580011 05391540580011 5391540580011
GMDN Terms# Term, Definition table Term Definition Tinnitus therapy translingual electrical stimulation electrode array A device designed to conduct electrical pulses from a system generator to the tongue as part of a bimodal neuromodulation therapy for tinnitus. It includes an electrode array and is intended to be placed in the mouth during therapy. This is a reusable device.
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 true Serial number false 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#