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VADER Pedicle System, Torque Wrench (Push-Mechanism), Hudson Coupling, 12Nm
FDA UDIEUDAMEDClass II (US FDA UDI)
by Icotec
Identity
- Trade Name
- VADER Pedicle System, Torque Wrench (Push-Mechanism), Hudson Coupling, 12Nm FDA UDI
- Generic Name
- Surgical instrument handle, torque-limiting FDA UDI
- Device Name
- VADER Pedicle System, Torque Wrench (Push-Mechanism), Hudson Coupling, 12Nm FDA UDI
- Model / Reference
- 42-703 FDA UDI
- Description
- VADER Pedicle System, Torque Wrench (Push-Mechanism), Hudson Coupling, 12Nm FDA UDI
Identifiers
- Catalog Number
- 42-703 FDA UDI
- Primary DI / UDI-DI
- 07640172552131 FDA UDI
- FDA Product Code
- NKB FDA UDI
- GMDN Term
- Surgical instrument handle, torque-limiting FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 888.3070 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
No
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
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
No
FDA UDI
Lot / Batch Number
No
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Moist Heat or Steam Sterilization FDA UDI
Category: Surgical instrument handle, torque-limiting
VADER Pedicle System, Torque Wrench (Push-Mechanism), Hudson Coupling, 12Nm by Icotec — Class II — MDR, FDA UDI — listed in FDA GUDID, EUDAMED
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Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Unknown
MDR
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | MDR | — | Class II | Unknown |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class II | Pending data |
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Manufacturer
- Manufacturer
- Icotec
Sources (2)
- FDA UDI 6f13d6b1-a3bc-4065-b0c7-e1f2b56894f5 35 fields · synced Jun 17, 2026
- EUDAMED 1 fields · synced Jun 3, 2026