FDA UDI In Commercial Distribution 🇺🇸 United States

Unitron TrueFit 5.9

DI: 07613389837827 · Model: n/a · Sonova AG
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1

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Basic Information

Brand Name
Unitron TrueFit 5.9
Primary DI
07613389837827
Version / Model
n/a
Catalog Number
088-5019-00058
Company Name
Sonova AG
Labeler DUNS
480662550
Distribution Status
In Commercial Distribution
Device Count in Pkg
1
Record Status
Published
Publish Date
2025-12-30
Public Version
1
Public Version Date
2026-01-07
Public Version Status
New
Public Device Record Key
b365c794-7777-4385-b1a5-018e9adfc946

Device Characteristics

Single Use
No
Prescription Use (Rx)
Yes
Over the Counter (OTC)
No
Kit
No
Combination Product
No
HCT/P
No
Contains NRL
No
Not Made with NRL
No
MRI Safety
MR Unsafe
Direct Marking Exempt
Yes
PM Exempt
Yes
Has Serial Number
Yes
Has Lot/Batch Number
No
Has Manufacturing Date
No
Has Expiration Date
No
Has Donation ID
No

Sterilization

Is Sterile
No
Sterilization Prior Use
No

Product Codes

Code Name
OSM Hearing Aid, Air-Conduction With Wireless Technology, Prescription

GMDN Terms

Code Name
60211 Audiometric/hearing device software

Identifiers

Type ID
Primary 07613389837827

Customer Contacts

Phone
+41589280101