Phonak Audéo ISphereTrial 050-1030-P6BB

GUDID 07613389808148

Sonova AG

Air-conduction hearing aid, receiver-in-canal
Primary Device ID07613389808148
NIH Device Record Key6980080b-b15e-4a52-88f3-c464bf75249c
Commercial Distribution StatusIn Commercial Distribution
Brand NamePhonak Audéo ISphereTrial
Version Model Number(silver gray)
Catalog Number050-1030-P6BB
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
GS107613389808148 [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 Date2025-01-16
Device Publish Date2025-01-08

On-Brand Devices [Phonak Audéo ISphereTrial ]

07613389699180(atlantic green)
07613389583038(silver gray)
07613389808148(silver gray)
07613389808131(silver gray)
07613389808124(atlantic green)
07613389808117(atlantic green)

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