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Driver Assembly, Counter Torque
EUDAMEDFDA UDIClass I (EU MDR)
Ref TC104000
by Tecomet, Inc
Identity
- Trade Name
- Driver Assembly, Counter Torque EUDAMEDTecomet FDA UDI
- Generic Name
- Orthopaedic counter-torque/rod-pushing instrument FDA UDI
- Device Name
- Counter Torques EUDAMEDDriver Assembly, Counter Torque FDA UDI
- Model / Reference
- TC104000 EUDAMEDFDA UDI
- Description
- Driver Assembly, Counter Torque FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00818069014490 EUDAMEDFDA UDI
- Basic UDI-DI
- 08180690147554N7 EUDAMED
- Direct Marketing DI
- 00818069014490 EUDAMED
- FDA Product Code
- HXX FDA UDI
- EMDN Code
- L0999 ORTHOPAEDIC AND TRAUMATOLOGICAL SURGERY INSTRUMENTS, REUSABLE - OTHER EUDAMED
- GMDN Term
- Orthopaedic counter-torque/rod-pushing instrument FDA UDI
Classification
- Device Class
- Class I EUDAMEDFDA UDI
- Regulation Number
- 888.4540 FDA UDI
- Market of Registration
- Belgium 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
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Moist Heat or Steam Sterilization FDA UDI
Driver Assembly, Counter Torque by Tecomet, Inc — 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 | 08180690147554N7 | Class I | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
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Manufacturer
- Manufacturer
- Tecomet, Inc
- EUDAMED SRN
- US-MF-000027544
- Authorised Representative
- Meditec Source GmbH & Co. KG DE-AR-000009318
Sources (2)
- EUDAMED 2ec0740a-14a1-493c-b44d-e4428f2024f8 61 fields · synced Sep 18, 2026
- FDA UDI 51663e83-7481-4585-b908-065bd6e8fbff 33 fields · synced May 29, 2026