FDA UDI In Commercial Distribution 🇺🇸 United States

AGXO

DI: 05714464108992 · Model: 255998 · Sbo Hearing A/S
Product Codes
2
GMDN Terms
1
Identifiers
1
Pkg Device Count
1

Basic Information

Brand Name
AGXO
Primary DI
05714464108992
Version / Model
255998
Company Name
Sbo Hearing A/S
Labeler DUNS
306018410
Distribution Status
In Commercial Distribution
Device Count in Pkg
1
Record Status
Published
Publish Date
2023-02-17
Public Version
1
Public Version Date
2023-02-27
Public Version Status
New
Public Device Record Key
bda59876-ae98-47f4-b56e-c063138fd306

Device Description

AGXO E400 MINIRITE R C091

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
No
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
KLW Masker, tinnitus

GMDN Terms

Code Name
56736 Air-conduction hearing aid, receiver-in-the-ear

Identifiers

Type ID
Primary 05714464108992

Customer Contacts

Phone
+4539177100