FDA UDI Not in Commercial Distribution 🇺🇸 United States

Ponto

DI: 05712149009640 · Model: M52321 · Oticon Medical AB
Product Codes
2
GMDN Terms
1
Identifiers
1
Pkg Device Count
1

Basic Information

Brand Name
Ponto
Primary DI
05712149009640
Version / Model
M52321
Catalog Number
M52321
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
5ec51ba9-7d35-46e4-9d3b-a50e7b533bfc
Distribution End Date
2017-05-15

Device Description

Abutment extension, 1 mm

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
MR Conditional
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
LXB Hearing Aid, Bone Conduction
MAH Hearing Aid, Bone Conduction, Implanted

GMDN Terms

Code Name
47847 Orthopaedic implant-instrument extension adaptor, reusable

Identifiers

Type ID
Primary 05712149009640

Customer Contacts

Phone
888-277-8014

Device Sizes

Type Value Unit Text
Height 1 Millimeter