AccessGUDID - DEVICE: Lenire (05391540582015)

GUDID

Device Identifier (DI) Information

Brand Name: Lenire
Version or Model: CR-201
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: NEUROMOD DEVICES LIMITED

Primary DI Number: 05391540582015
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 985051113 *Terms of Use

Device Description: Lenire Tinnitus Treatment Device

Device Characteristics

What MRI safety information does the labeling contain?	Labeling does not contain MRI Safety Information
Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437):	No
Device labeled as "Not made with natural rubber latex":	No
For Single-Use:	No
Prescription Use (Rx):	Yes
Over the Counter (OTC):	No
Kit:	No
Combination Product:	No
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P):	No

GMDN

[?]

GMDN Term Code	GMDN Term Name	GMDN Term Definition	GMDN Term Status [?]	Implantable?
65707	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.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
QVN	Combined Acoustic And Electrical External Stimulation Device For The Relief Of Tinnitus

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
DEN210033	000

Device Exempt from Premarket Submission: No CLOSE

Sterilization

Device Packaged as Sterile: No
Requires Sterilization Prior to Use: No

Sterilization Method [?]
No Sterilization Methods Found

Storage and Handling

[?]

Storage and Handling
No storage/handling found

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 193286b2-8ee4-4045-9d41-1e02a070e98c
Public Version Date: April 24, 2024
Public Version Number: 2
DI Record Publish Date: May 19, 2023

Alternative and Additional Identifiers Additional Identifiers

Package DI

[?]

Package DI Number	Quantity per Package	Contains DI Package	Package Discontinue Date	Package Status	Package Type
No Package DIs found

Secondary DI

[?]

Issuing Agency [?]	Secondary DI Number
No Secondary DIs found

Unit of Use DI

[?]

Unit of Use DI Number: No Unit of Use DI Numbers Found CLOSE

Direct Marking (DM)

[?]

Device Subject to Direct Marking (DM), but Excepted: No
DM DI Different from Primary DI: No
DM DI Number: None
CLOSE

Production Identifier(s) in UDI

[?]

Lot or Batch Number: No
Serial Number: Yes
Expiration Date: No
Manufacturing Date: Yes
Donation Identification Number: No CLOSE

Customer Contact

[?]

No Customer Contact currently defined

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