AccessGUDID - DEVICE: Sonite R Kit Monaural US (07613389806267)

GUDID

Device Identifier (DI) Information

Brand Name: Sonite R Kit Monaural US
Version or Model: (velvet black)
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 051-0219-P856
Company Name: Sonova AG

Primary DI Number: 07613389806267
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 480662550 *Terms of Use

Device Description: Sonite R Kit Monaural US (velvet black) - Primary DI number: 07613389806267 1x Sennheiser Sonite R (velvet black) - Primary DI number: 07613389804027 and 1 x Sennheiser S Charger R - Primary DI number: 07613389738643

Device Characteristics

What MRI safety information does the labeling contain?	MR Unsafe
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):	No
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?
47169	Air-conduction hearing aid, receiver-in-canal	A battery-powered acoustic device intended to compensate for impaired hearing by transmitting amplified sound waves to the eardrum through air. It consists of a microphone and an amplifier in a case behind-the-ear (BTE) connected, via a wire, to a receiver (speaker) in the ear canal [receiver-in-canal (RIC)]. The microphone receives sound waves and converts them into electrical signals which are increased by the amplifier and sent as sound waves, by the speaker, to the eardrum. The device is used for mild to profound hearing loss; most types are programmable to enable computerized adjustments for a patient's hearing loss and related factors.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
OSM	Hearing Aid, Air-Conduction With Wireless Technology, Prescription
KLW	Masker, Tinnitus

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
Premarket Submission Number Not Available/Not Released

Device Exempt from Premarket Submission: Yes 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: fef4a7cb-e366-432b-8013-9633b83a0c23
Public Version Date: March 28, 2025
Public Version Number: 1
DI Record Publish Date: March 20, 2025