FDA UDI Not in Commercial Distribution 🇺🇸 United States

Ponto

DI: 05712149010851 · Model: M52322 · Oticon Medical AB
Product Codes
2
GMDN Terms
1
Identifiers
1
Pkg Device Count
1

Basic Information

Brand Name
Ponto
Primary DI
05712149010851
Version / Model
M52322
Catalog Number
M52322
Company Name
Oticon Medical AB
Labeler DUNS
554563994
Distribution Status
Not in Commercial Distribution
Device Count in Pkg
1
Record Status
Published
Publish Date
2016-09-16
Public Version
4
Public Version Date
2023-05-03
Public Version Status
Update
Public Device Record Key
f8c4417b-c36c-4b73-bc06-b588243834a8
Distribution End Date
2017-05-15

Device Description

Adapter, Abutment extension

Device Characteristics

Single Use
Yes
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
Labeling does not contain MRI Safety Information
Direct Marking Exempt
No
PM Exempt
No
Has Serial Number
No
Has Lot/Batch Number
Yes
Has Manufacturing Date
No
Has Expiration Date
No
Has Donation ID
No

Sterilization

Is Sterile
No
Sterilization Prior Use
No

Product Codes

Code Name
MAH Hearing Aid, Bone Conduction, Implanted
LXB Hearing Aid, Bone Conduction

GMDN Terms

Code Name
47847 Orthopaedic implant-instrument extension adaptor, reusable

Identifiers

Type ID
Primary 05712149010851

Customer Contacts

Phone
888-277-8014