Lenire

GUDID 05391540580158

Lenire Tonguetip

NEUROMOD DEVICES LIMITED

Tinnitus therapy translingual electrical stimulation electrode array

• Primary Device ID: 05391540580158
• NIH Device Record Key: 8c270fac-dab8-41e6-8539-8da2f2e9fca0
• 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

Operating and Storage Conditions

• Handling Environment Humidity: Between 5 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
• Handling Environment Temperature: Between -20 Degrees Celsius and 45 Degrees Celsius
• Handling Environment Humidity: Between 5 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
• Handling Environment Temperature: Between -20 Degrees Celsius and 45 Degrees Celsius
• Handling Environment Humidity: Between 5 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
• Handling Environment Temperature: Between -20 Degrees Celsius and 45 Degrees Celsius
• Handling Environment Humidity: Between 5 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
• Handling Environment Temperature: Between -20 Degrees Celsius and 45 Degrees Celsius
• Handling Environment Humidity: Between 5 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
• Handling Environment Temperature: Between -20 Degrees Celsius and 45 Degrees Celsius
• Handling Environment Humidity: Between 5 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
• Handling Environment Temperature: Between -20 Degrees Celsius and 45 Degrees Celsius
• Handling Environment Humidity: Between 5 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
• Handling Environment Temperature: Between -20 Degrees Celsius and 45 Degrees Celsius
• Handling Environment Humidity: Between 5 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
• Handling Environment Temperature: Between -20 Degrees Celsius and 45 Degrees Celsius
• Handling Environment Humidity: Between 5 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
• Handling Environment Temperature: Between -20 Degrees Celsius and 45 Degrees Celsius
• Handling Environment Humidity: Between 5 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
• Handling Environment Temperature: Between -20 Degrees Celsius and 45 Degrees Celsius
• Handling Environment Humidity: Between 5 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
• Handling Environment Temperature: Between -20 Degrees Celsius and 45 Degrees Celsius
• Handling Environment Humidity: Between 5 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
• Handling Environment Temperature: Between -20 Degrees Celsius and 45 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
GS1	05391540580158 [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: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2026-03-02
• Device Publish Date: 2026-02-20

On-Brand Devices [Lenire]

• 05391540580028: Lenire Tinnitus Treatment Device
• 05391540580011: Lenire Tonguetip
• 05391540582015: Lenire Tinnitus Treatment Device
• 05391540581018: Lenire Tonguetip
• 05391540580158: Lenire Tonguetip
• 05391540580141: Lenire Tinnitus Treatment Device