Home GUDID 05391540580158 Lenire
Primary DI 05391540580158
Brand Lenire
Company NEUROMOD DEVICES LIMITED
Model TP-101
Device description Lenire Tonguetip
Published 2026-02-20
Public version status New
Distribution status In Commercial Distribution
MRI safety Labeling does not contain MRI Safety Information
Rx true 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 05391540580158 Primary GS1 0
Alternate GTIN / UPC / EAN Codes Source identifier, GTIN-14 normalized, EAN-13 table Source identifier GTIN-14 normalized EAN-13 05391540580158 05391540580158 5391540580158
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.
Storage And Handling# Type, Low, High table Type Low High Condition Handling Environment Humidity 5 Percent (%) Relative Humidity 85 Percent (%) Relative Humidity Handling Environment Temperature -20 Degrees Celsius 45 Degrees Celsius
Regulatory Flags# DUNS number 985051113 Device count 1 Lot or batch true Manufacturing date on label true Other Devices From This Company# Other Devices Sharing Product Codes#