Identity
- Trade Name
- Screwdriver HexaDrive EUDAMEDFDA UDI
- Generic Name
- Surgical screwdriver, reusable FDA UDI
- Device Name
- Screwdriver HexaDrive EUDAMEDScrewdriver HexaDrive. Consists of blade (DM DI 05712149027415) and handle (DM DI 057121490274225). FDA UDI
- Model / Reference
- 265497 EUDAMEDFDA UDI
- Description
- Screwdriver HexaDrive. Consists of blade (DM DI 05712149027415) and handle (DM DI 057121490274225). FDA UDI
Identifiers
- Catalog Number
- 265497 FDA UDI
- Primary DI / UDI-DI
- 05712149027408 EUDAMEDFDA UDI
- Basic UDI-DI
- 57121491002086 EUDAMED
- Direct Marketing DI
- 05712149027415 EUDAMED
- FDA Product Code
- LRC FDA UDI
- EMDN Code
- L149099 ENT INSTRUMENTS, REUSABLE - OTHER EUDAMED
- GMDN Term
- Surgical screwdriver, reusable FDA UDI
Classification
- Device Class
- Class I EUDAMEDFDA UDI
- Regulation Number
- 874.4420 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
Yes
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
Yes
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
Screwdriver HexaDrive by Oticon Medical AB — Class I — 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 | 57121491002086 | Class I | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
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Manufacturer
- Manufacturer
- Oticon Medical AB
- EUDAMED SRN
- SE-MF-000000724
Sources (2)
- EUDAMED 3adb629e-8809-44e9-a482-0e19c3637517 61 fields · synced Jun 19, 2026
- FDA UDI 96ccc30e-603b-4b9e-9343-dabccdd9aa5d 35 fields · synced May 30, 2026