Identity
- Trade Name
- Handle with screwdriver EUDAMEDPonto FDA UDI
- Generic Name
- Surgical screwdriver, reusable FDA UDI
- Device Name
- Screwdriver EUDAMEDHandle with screwdriver. Consists of handle (DM DI 05712149024568) and screwdriver machine bit (DM DI 05712149000562). FDA UDI
- Model / Reference
- M50437 EUDAMEDFDA UDI
- Description
- Handle with screwdriver. Consists of handle (DM DI 05712149024568) and screwdriver machine bit (DM DI 05712149000562). FDA UDI
Identifiers
- Catalog Number
- M50437 FDA UDI
- Primary DI / UDI-DI
- 05712149000654 EUDAMEDFDA UDI
- Basic UDI-DI
- 5712149100068C EUDAMED
- Direct Marketing DI
- 05712149000562 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
Handle with screwdriver 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 | 5712149100068C | Class IIa | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class IIa | Pending data |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Oticon Medical AB
- EUDAMED SRN
- SE-MF-000000724
Sources (2)
- EUDAMED 9d8c0404-0ab1-4abc-9d0e-14f11e4ddc52 61 fields · synced Jun 18, 2026
- FDA UDI 4b404273-e8d9-4f13-8c0d-3690b0adc42f 35 fields · synced May 30, 2026