Identity
- Trade Name
- devemed FDA UDI
- Generic Name
- Surgical screwdriver, reusable FDA UDI
- Device Name
- Screw Drivers EUDAMED1.3 Ø dev-os system | QUADRO Screwdriver blade | long | 70 mm with dental fitting FDA UDI
- Model / Reference
- 4213-20 EUDAMEDFDA UDI
- Description
- 1.3 Ø dev-os system | QUADRO Screwdriver blade | long | 70 mm with dental fitting FDA UDI
Identifiers
- Primary DI / UDI-DI
- 04061644031528 EUDAMEDFDA UDI
- Basic UDI-DI
- 4061644PG1503013M EUDAMED
- FDA Product Code
- NDP FDA UDI
- EMDN Code
- L091001 INSTRUMENTS FOR INSERTION AND EXTRACTION OF MATERIALS FOR OSTEOSYNTHESIS, REUSABLE EUDAMED
- GMDN Term
- Surgical screwdriver, reusable FDA UDI
Classification
- Device Class
- Class I EUDAMEDFDA UDI
- Regulation Number
- 872.3980 FDA UDI
- Market of Registration
- Germany EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
EUDAMEDFDA UDI
Single Use
No
FDA UDI
Implantable
No
EUDAMEDFDA UDI
Reusable
No
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
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
Screw Drivers by devemed GmbH — 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 | 4061644PG1503013M | Class I | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
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Manufacturer
- Manufacturer
- devemed GmbH
- EUDAMED SRN
- DE-MF-000005568
Sources (2)
- EUDAMED ee84121e-57c7-4378-8393-ea06faec754e 61 fields · synced Jun 19, 2026
- FDA UDI 52dca401-9b69-451b-b417-ea9f8771d3af 34 fields · synced May 30, 2026