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VADER® Pedicle System Cannulated Tap Ø 7.5 mm
EUDAMEDFDA UDIClass IIa (EU MDR)
Ref 42-641Model Tap
by icotec ag
Identity
- Trade Name
- VADER® Pedicle System Cannulated Tap Ø 7.5 mm EUDAMEDVADER Pedicle System, Cannulated Tap, Ø 7.5 mm FDA UDI
- Generic Name
- Bone tap, reusable FDA UDI
- Device Name
- VADER Pedicle System, Cannulated Tap, Ø 7.5 mm FDA UDI
- Model / Reference
- Tap EUDAMED42-641 EUDAMEDFDA UDI
- Description
- VADER Pedicle System, Cannulated Tap, Ø 7.5 mm FDA UDI
Identifiers
- Catalog Number
- 42-641 FDA UDI
- Primary DI / UDI-DI
- 07640172552520 EUDAMEDFDA UDI
- Basic UDI-DI
- 764017255iPSI0004AU EUDAMED
- Direct Marketing DI
- 07640172552520 EUDAMED
- FDA Product Code
- NKB FDA UDI
- EMDN Code
- L1109 NEUROSURGERY AND SPINAL SURGERY INSTRUMENT KITS, REUSABLE EUDAMED
- GMDN Term
- Bone tap, reusable 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 Cannulated Tap Ø 7.5 mm 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 | 764017255iPSI0004AU | 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 cea57e8f-16c1-405c-9239-15fd6b20f6bf 61 fields · synced Jul 13, 2026
- FDA UDI 68e95b06-2a1d-44b9-b45f-1e236b891f5b 35 fields · synced May 30, 2026