FDA UDI In Commercial Distribution 🇺🇸 United States

audifon

DI: EADF0298089713315917201 · Model: lewi S · audifon GmbH & Co. KG
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1

Basic Information

Brand Name
audifon
Primary DI
EADF0298089713315917201
Version / Model
lewi S
Catalog Number
029808-9713-3159-1720
Company Name
audifon GmbH & Co. KG
Labeler DUNS
344064407
Distribution Status
In Commercial Distribution
Device Count in Pkg
1
Record Status
Published
Publish Date
2024-11-21
Public Version
2
Public Version Date
2026-01-09
Public Version Status
Update
Public Device Record Key
d7bc03fe-f614-46f2-ae3d-1b642601067a

Device Description

audifon lewi S -- graphit BTE

Device Characteristics

Single Use
No
Prescription Use (Rx)
No
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
No
PM Exempt
Yes
Has Serial Number
Yes
Has Lot/Batch Number
No
Has Manufacturing Date
Yes
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
34671 Air-conduction hearing aid, behind-the-ear

Identifiers

Type ID
Primary EADF0298089713315917201