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Repair Torque Driver For Torque Wrench
EUDAMEDFDA UDIClass I (EU MDR)
Ref TRHD12LRRef HTRHD12LRRef TRHD12ERRef TRHD12SRRef HTRHD12SR
Identity
- Trade Name
- REPAIR TORQUE DRIVER FOR TORQUE WRENCH EUDAMEDREPAIR TORQUE DRIVER FOR TORQUE WRENCH EUDAMEDFDA UDIRepair Torque Driver For Wrench EUDAMEDFDA UDI
- Generic Name
- Surgical screwdriver, reusable FDA UDI
- Device Name
- Surgical Instrument System EUDAMED
- Model / Reference
- TRHD12LR EUDAMEDFDA UDITRHD12SR EUDAMEDFDA UDIHTRHD12SR EUDAMEDFDA UDIHTRHD12LR EUDAMEDFDA UDITRHD12ER EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08800040627807 EUDAMEDFDA UDI08809917072702 EUDAMEDFDA UDI08800209373880 EUDAMEDFDA UDI08800209373842 EUDAMEDFDA UDI08809917165558 EUDAMED
- Basic UDI-DI
- 88000406CLASSIBS25V EUDAMED
- FDA Product Code
- NDP FDA UDI
- EMDN Code
- L159099 ODONTOSTOMATOLOGY INSTRUMENTS, REUSABLE - OTHER EUDAMED
- GMDN Term
- Surgical screwdriver, reusable FDA UDI
Classification
- Device Class
- Class I EUDAMEDFDA UDI
- Regulation Number
- 872.3980 FDA UDI
- Market of Registration
- Czechia 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
Yes
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Moist Heat or Steam Sterilization FDA UDI
Repair Torque Driver For Torque Wrench by Osstem Implant Co., Ltd. — 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 | 88000406CLASSIBS25V | Class I | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
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Manufacturer
- Manufacturer
- OSSTEM IMPLANT Co., Ltd.
- EUDAMED SRN
- KR-MF-000020006
- Authorised Representative
- Obelis s.a. BE-AR-000000106
Sources (9)
- EUDAMED 059263b5-2a98-4c46-abdf-0fdba22d20fb 61 fields · synced Jul 13, 2026
- FDA UDI e8ddabc9-46f9-48e7-9fa6-264e5d8327e5 32 fields · synced May 29, 2026
- FDA UDI 4d679508-95e3-471b-bf29-27dfcb9bbd32 32 fields · synced May 30, 2026
- FDA UDI b9a9de17-48e2-4da1-a6fb-bb3ad407e6ef 32 fields · synced May 30, 2026
- FDA UDI 6333948c-f24b-41ed-a813-2a726d177d5c 32 fields · synced May 30, 2026
- EUDAMED af5f260f-ff4a-4d03-ade7-e67c6acd41db 61 fields · synced Jul 9, 2026
- EUDAMED 74084a4b-41b8-4000-88c1-b05905c1818c 61 fields · synced Jul 11, 2026
- EUDAMED 2f96d593-6e2b-4335-99c1-ee435e22e56e 61 fields · synced Jul 12, 2026
- EUDAMED 797973d1-cd81-4bc7-9fc8-d53a1913374b 61 fields · synced Jul 13, 2026