GEERS 4 088-0027-00043

GUDID 07613389793987

Sonova AG

Audiometric/hearing device software
Primary Device ID07613389793987
NIH Device Record Key2d31219e-6973-4d38-a6e0-50dcf353b0ce
Commercial Distribution StatusIn Commercial Distribution
Brand NameGEERS 4
Version Model Number4.3
Catalog Number088-0027-00043
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 Batchtrue
Serial Numberfalse
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
GS107613389793987 [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 Date2024-11-20
Device Publish Date2024-11-12

On-Brand Devices [GEERS 4]

076133897939874.3
076133897939564.2
076133897939254.1
076133897938954.0

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.