Identity
- Trade Name
- Abutment inserter, machine EUDAMEDPonto FDA UDI
- Generic Name
- Surgical screwdriver, reusable FDA UDI
- Device Name
- Abutment inserter EUDAMEDAbutment inserter, machine FDA UDI
- Model / Reference
- M51695 EUDAMEDFDA UDI
- Description
- Abutment inserter, machine FDA UDI
Identifiers
- Catalog Number
- M51695 FDA UDI
- Primary DI / UDI-DI
- 05712149005895 EUDAMEDFDA UDI
- Basic UDI-DI
- 5712149100158D EUDAMED
- Direct Marketing DI
- 05712149005895 EUDAMED
- FDA Product Code
- MAH FDA UDI
- EMDN Code
- L149099 ENT INSTRUMENTS, REUSABLE - OTHER EUDAMED
- GMDN Term
- Surgical screwdriver, reusable FDA UDI
Classification
- Device Class
- Class IIa EUDAMEDClass II FDA UDI
- Regulation Number
- 874.3302 FDA UDI
- Market of Registration
- Sweden EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
EUDAMEDFDA UDI
Single Use
No
FDA UDI
Implantable
No
EUDAMEDFDA UDI
Reusable
Yes
EUDAMED
Contains Latex
No
EUDAMEDFDA UDI
Reprocessed
No
EUDAMED
CMR Substance
No
EUDAMED
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Endocrine Disruptor
No
EUDAMED
Administering Medicine
No
EUDAMED
Measuring Function
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
Prescription Use
Yes
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
No
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
Moist Heat or Steam Sterilization FDA UDI
Abutment inserter, machine by Oticon Medical AB — Class IIa — MDR, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Active
CE/MDR
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | 5712149100158D | Class IIa | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class IIa | Pending data |
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Manufacturer
- Manufacturer
- Oticon Medical AB
- EUDAMED SRN
- SE-MF-000000724
Sources (2)
- EUDAMED 9cf4c1de-7fab-40de-8a99-ba93d299722f 61 fields · synced Oct 6, 2026
- FDA UDI a6197c48-389e-4197-8e3e-006190c25088 35 fields · synced May 30, 2026