Sonite R Kit Monaural US 051-0219-H056

GUDID 07613389804041

Sonite R Kit Monaural US (beige) - Primary DI number: 07613389804041 1 x Sennheiser Sonite R (beige) - Primary DI number: 07613389803990 and 1 x Sennheiser S Charger R - Primary DI number: 07613389738643

Sonova AG

Air-conduction hearing aid, receiver-in-canal
Primary Device ID07613389804041
NIH Device Record Key7e16af10-1ee3-4a85-8e3a-30a113d54dc6
Commercial Distribution StatusIn Commercial Distribution
Brand NameSonite R Kit Monaural US
Version Model Number(beige)
Catalog Number051-0219-H056
Company DUNS480662550
Company NameSonova AG
Device Count1
DM Exemptfalse
Pre-market Exempttrue
MRI Safety StatusMR Unsafe
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usefalse
Lot Batchfalse
Serial Numbertrue
Manufacturing Datetrue
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptionfalse
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS107613389804041 [Primary]

FDA Product Code

OSMHearing Aid, Air-Conduction With Wireless Technology, Prescription

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2025-03-28
Device Publish Date2025-03-20

On-Brand Devices [Sonite R Kit Monaural US ]

07613389806267Sonite R Kit Monaural US (velvet black) - Primary DI number: 07613389806267 1x Sennheiser Sonite
07613389806250Sonite R Kit Monaural US (silver gray) - Primary DI number: 07613389806250 1x Sennheiser Sonite
07613389806243Sonite R Kit Monaural US (sandalwood) - Primary DI number: 07613389806243 1x Sennheiser Sonite R
07613389804041Sonite R Kit Monaural US (beige) - Primary DI number: 07613389804041 1 x Sennheiser Sonite R (b

© 2025 FDA.report
This site is not affiliated with or endorsed by the FDA.