Unitron TrueFit 5.8 DVD 058-5178-058

GUDID 07613389790207

Sonova AG

Audiometric/hearing device software
Primary Device ID07613389790207
NIH Device Record Keyaa3f2f6e-2952-4478-b964-85696d251e59
Commercial Distribution StatusIn Commercial Distribution
Brand NameUnitron TrueFit 5.8 DVD
Version Model Numbern/a
Catalog Number058-5178-058
Company DUNS480662550
Company NameSonova AG
Device Count1
DM Exempttrue
Pre-market Exempttrue
MRI Safety StatusMR Unsafe
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usefalse
Lot Batchfalse
Serial Numbertrue
Manufacturing Datefalse
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone+41589280101
Emailinfo@sonova.com
Phone+41589280101
Emailinfo@sonova.com
Phone+41589280101
Emailinfo@sonova.com
Phone+41589280101
Emailinfo@sonova.com
Phone+41589280101
Emailinfo@sonova.com
Phone+41589280101
Emailinfo@sonova.com
Phone+41589280101
Emailinfo@sonova.com
Phone+41589280101
Emailinfo@sonova.com
Phone+41589280101
Emailinfo@sonova.com
Phone+41589280101
Emailinfo@sonova.com
Phone+41589280101
Emailinfo@sonova.com
Phone+41589280101
Emailinfo@sonova.com
Phone+41589280101
Emailinfo@sonova.com
Phone+41589280101
Emailinfo@sonova.com
Phone+41589280101
Emailinfo@sonova.com
Phone+41589280101
Emailinfo@sonova.com

Device Identifiers

Device Issuing AgencyDevice ID
GS107613389790207 [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 Date2025-04-09
Device Publish Date2025-04-01

Devices Manufactured by Sonova AG

07613389831726 - Sennheiser Sonite R Loaner 2025-04-11
07613389790184 - Unitron TrueFit 5.82025-04-09
07613389790191 - Unitron TrueFit 5.8 USB2025-04-09
07613389790207 - Unitron TrueFit 5.8 DVD2025-04-09
07613389790207 - Unitron TrueFit 5.8 DVD2025-04-09
07613389792317 - Aura:fit 5.82025-04-09
07613389792324 - Aura:fit AudioNova 5.82025-04-09
07613389792331 - Aura:fit Relate 5.82025-04-09
07613389797909 - Au V-312 trial2025-04-01

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