Driver T10, for RemeOs™ Screw 3.5/4.0 mm, quick coupling
EUDAMEDFDA UDIClass I (EU MDR)
Identity
- Trade Name
- Driver T10, for RemeOs™ Screw 3.5/4.0 mm, quick coupling EUDAMEDRemeOs Instrument FDA UDI
- Generic Name
- Surgical screwdriver, reusable FDA UDI
- Device Name
- Torx Driver EUDAMED
- Model / Reference
- B-IRC-4002 EUDAMEDFDA UDI
Identifiers
- Primary DI / UDI-DI
- 06438394012981 EUDAMEDFDA UDI
- Basic UDI-DI
- 6438394INS016WT EUDAMED
- Direct Marketing DI
- 06438394012981 EUDAMED
- FDA Product Code
- LXH FDA UDI
- EMDN Code
- L26 SURGICAL SCREWDRIVERS, REUSABLE EUDAMED
- GMDN Term
- Surgical screwdriver, reusable FDA UDI
Classification
- Device Class
- Class I EUDAMEDFDA UDI
- Regulation Number
- 888.4540 FDA UDI
- Market of Registration
- Finland EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
Single Use
No
Implantable
No
Reusable
Yes
Contains Latex
No
Reprocessed
No
CMR Substance
No
Human-derived
No
Human Tissues
No
Animal Tissues
No
Endocrine Disruptor
No
Administering Medicine
No
Measuring Function
No
Incorporates Medicinal Product
No
Prescription Use
Yes
Over-the-Counter
No
Convenience Kit
No
Combination Product
No
HCT/P
No
Premarket Exempt
Yes
Lot / Batch Number
Yes
Serial Number
No
Expiration Date
No
Manufacturing Date
No
Category: Surgical screwdriver, reusable
Driver T10, for RemeOs™ Screw 3.5/4.0 mm, quick coupling by Bioretec Ltd. — Class I — MDR, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
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Authorization Coverage (2 countries)
Regulatory Authorizations
CE/MDR
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | 6438394INS016WT | Class I | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
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Manufacturer
- Manufacturer
- Bioretec Ltd.
- EUDAMED SRN
- FI-MF-000001328
Sources (2)
- EUDAMED b1967015-2a0d-470f-9810-6e2e8b770630 61 fields · synced Jul 11, 2026
- FDA UDI 2e36bb78-efef-4d6e-b4dd-16fd50d06995 32 fields · synced May 25, 2026