FDA UDI Not in Commercial Distribution 🇺🇸 United States

Phonak Audéo I-R Trial

DI: 07613389808070 · Model: (atlantic green) · Sonova AG
Product Codes
2
GMDN Terms
1
Identifiers
1
Pkg Device Count
1

Basic Information

Brand Name
Phonak Audéo I-R Trial
Primary DI
07613389808070
Version / Model
(atlantic green)
Catalog Number
050-1044-9ABA
Company Name
Sonova AG
Labeler DUNS
480662550
Distribution Status
Not in Commercial Distribution
Device Count in Pkg
1
Record Status
Published
Publish Date
2025-01-08
Public Version
2
Public Version Date
2025-03-07
Public Version Status
Update
Public Device Record Key
875d5cc4-156b-4034-9927-6aa06ae92977
Distribution End Date
2025-03-03

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
KLW Masker, Tinnitus

GMDN Terms

Code Name
47169 Air-conduction hearing aid, receiver-in-canal

Identifiers

Type ID
Primary 07613389808070