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Driver Assembly, Sleeve Nut, Advanced Spine
EUDAMEDFDA UDIClass I (EU MDR)
Ref CD101003
by Tecomet, Inc
Identity
- Trade Name
- Driver Assembly, Sleeve Nut, Advanced Spine EUDAMEDTecomet FDA UDI
- Generic Name
- Surgical screwdriver, reusable FDA UDI
- Device Name
- Hex Driver EUDAMEDDVR ASY, SLV NUT FDA UDI
- Model / Reference
- CD101003 EUDAMEDFDA UDI
- Description
- DVR ASY, SLV NUT FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00818069013035 EUDAMEDFDA UDI
- Basic UDI-DI
- 08180690133968MX EUDAMED
- Direct Marketing DI
- 00818069013035 EUDAMED
- FDA Product Code
- HTW FDA UDI
- EMDN Code
- L0999 ORTHOPAEDIC AND TRAUMATOLOGICAL SURGERY INSTRUMENTS, REUSABLE - OTHER EUDAMED
- GMDN Term
- Surgical screwdriver, reusable 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, Sleeve Nut, Advanced Spine 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 | 08180690133968MX | 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 6192f47f-df54-4922-9313-a3b668fd5929 61 fields · synced Sep 18, 2026
- FDA UDI ede1f477-2762-4e67-be00-b9fa5e9718ca 33 fields · synced May 29, 2026