Lenire

GUDID 05391540581018

Lenire Tonguetip

NEUROMOD DEVICES LIMITED

Tinnitus therapy translingual electrical stimulation electrode array Tinnitus therapy translingual electrical stimulation electrode array Tinnitus therapy translingual electrical stimulation electrode array Tinnitus therapy translingual electrical stimulation electrode array Tinnitus therapy translingual electrical stimulation electrode array Tinnitus therapy translingual electrical stimulation electrode array Tinnitus therapy translingual electrical stimulation electrode array Tinnitus therapy translingual electrical stimulation electrode array Tinnitus therapy translingual electrical stimulation electrode array Tinnitus therapy translingual electrical stimulation electrode array Tinnitus therapy translingual electrical stimulation electrode array Tinnitus therapy translingual electrical stimulation electrode array Tinnitus therapy translingual electrical stimulation electrode array Tinnitus therapy translingual electrical stimulation electrode array Tinnitus therapy translingual electrical stimulation electrode array Tinnitus therapy translingual electrical stimulation electrode array Tinnitus therapy translingual electrical stimulation electrode array

• Primary Device ID: 05391540581018
• NIH Device Record Key: c94bafb4-8677-4fdc-b1b8-8cc0e0601fa6
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Lenire
• Version Model Number: TP-101
• Company DUNS: 985051113
• Company Name: NEUROMOD DEVICES LIMITED
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: false
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: true
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	05391540581018 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• deNovo: DEN210033

FDA Product Code

• QVN: Combined Acoustic And Electrical External Stimulation Device For The Relief Of Tinnitus

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 2
• Public Version Date: 2024-04-24
• Device Publish Date: 2023-05-19

On-Brand Devices [Lenire]

• 05391540580028: Lenire Tinnitus Treatment Device
• 05391540580011: Lenire Tonguetip
• 05391540582015: Lenire Tinnitus Treatment Device
• 05391540581018: Lenire Tonguetip