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VADER® Pedicle System Distractor/Compressor MIS
EUDAMEDFDA UDIClass IIa (EU MDR)
Ref 42-772Model Distractor/Compressor MIS
by icotec ag
Identity
- Trade Name
- VADER® Pedicle System Distractor/Compressor MIS EUDAMEDVADER Pedicle System, Distractor/Compressor MIS FDA UDI
- Generic Name
- Orthopaedic implant driver FDA UDI
- Device Name
- VADER Pedicle System, Distractor/Compressor MIS FDA UDI
- Model / Reference
- Distractor/Compressor MIS EUDAMED42-772 EUDAMEDFDA UDI
- Description
- VADER Pedicle System, Distractor/Compressor MIS FDA UDI
Identifiers
- Catalog Number
- 42-772 FDA UDI
- Primary DI / UDI-DI
- 07640164844466 EUDAMEDFDA UDI
- Basic UDI-DI
- 764017255iPSI0011AR EUDAMED
- Direct Marketing DI
- 07640164844466 EUDAMED
- FDA Product Code
- NKB FDA UDI
- EMDN Code
- L1109 NEUROSURGERY AND SPINAL SURGERY INSTRUMENT KITS, REUSABLE EUDAMED
- GMDN Term
- Orthopaedic implant driver FDA UDI
Classification
- Device Class
- Class IIa EUDAMEDClass II FDA UDI
- Regulation Number
- 888.3070 FDA UDI
- Market of Registration
- Germany 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
No
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
VADER® Pedicle System Distractor/Compressor MIS by icotec AG — Class IIa — 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 | 764017255iPSI0011AR | Class IIa | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class IIa | Pending data |
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Manufacturer
- Manufacturer
- icotec ag
- EUDAMED SRN
- CH-MF-000026833
- Authorised Representative
- icotec Medical GmbH DE-AR-000016837
Sources (2)
- EUDAMED f4e19aa2-fbad-4562-9fab-26b07950ee63 61 fields · synced Jun 18, 2026
- FDA UDI a863535f-68e4-43b9-a20f-e68426a04eb6 35 fields · synced May 30, 2026