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VADER® Pedicle System VADER® Pedicle System MIS 2/2 Container Inlay
EUDAMEDFDA UDIClass I (EU MDR)
Ref 42-863-3Model ContainerRef 42-863-1Ref 42-862-2
by icotec ag
Identity
- Trade Name
- VADER® Pedicle System VADER® Pedicle System MIS 2/2 Container Inlay EUDAMEDVADER® Pedicle System VADER® Pedicle System MIS 2/2 Container Base EUDAMEDVADER® Pedicle System VADER® Pedicle System MIS 2/2 Container Lid EUDAMEDVADER Pedicle System VADER Pedicle System MIS 2/2 Container Base FDA UDIicotec Instrument, Pedicle System MIS 2/2, Container Lid FDA UDIVADER Pedicle System VADER Pedicle System MIS 2/2 Container Inlay FDA UDI
- Generic Name
- Device sterilization/disinfection container, reusable FDA UDI
- Device Name
- VADER Pedicle System VADER Pedicle System MIS 2/2 Container Base FDA UDIicotec Instrument, Pedicle System MIS 2/2, Container Lid FDA UDIVADER Pedicle System VADER Pedicle System MIS 2/2 Container Inlay FDA UDI
- Model / Reference
- Container EUDAMED42-863-3 EUDAMEDFDA UDI42-863-1 EUDAMEDFDA UDI42-862-2 EUDAMEDFDA UDI
- Description
- VADER Pedicle System VADER Pedicle System MIS 2/2 Container Base FDA UDIicotec Instrument, Pedicle System MIS 2/2, Container Lid FDA UDIVADER Pedicle System VADER Pedicle System MIS 2/2 Container Inlay FDA UDI
Identifiers
- Catalog Number
- 42-863-1 FDA UDI42-862-2 FDA UDI42-863-3 FDA UDI
- Primary DI / UDI-DI
- 07640172552261 EUDAMEDFDA UDI07640172552162 EUDAMEDFDA UDI07640172551240 EUDAMEDFDA UDI
- Basic UDI-DI
- 764017255iPSI0006AY EUDAMED
- Direct Marketing DI
- 07640172552261 EUDAMED07640172552162 EUDAMED07640172551240 EUDAMED
- FDA Product Code
- NKB FDA UDI
- EMDN Code
- L1109 NEUROSURGERY AND SPINAL SURGERY INSTRUMENT KITS, REUSABLE EUDAMED
- GMDN Term
- Device sterilization/disinfection container, reusable FDA UDI
Classification
- Device Class
- Class I 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
No
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 UDIFDA UDI
Moist Heat or Steam Sterilization FDA UDI
Category: Device sterilization/disinfection container, reusable
VADER® Pedicle System VADER® Pedicle System MIS 2/2 Container Inlay by icotec AG — Class I — MDR, FDA UDI — listed in EUDAMED, FDA GUDID
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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 | 764017255iPSI0006AY | Class I | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
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Manufacturer
- Manufacturer
- icotec ag
- EUDAMED SRN
- CH-MF-000026833
- Authorised Representative
- icotec Medical GmbH DE-AR-000016837
Sources (6)
- EUDAMED d1f2ccd6-9564-4150-856e-cb3b6d8d564c 61 fields · synced Jul 16, 2026
- FDA UDI b59de098-e293-4faf-9bf1-459b1b40d6b3 35 fields · synced May 30, 2026
- FDA UDI 3de8730e-7682-4060-8787-cd63f9697f23 35 fields · synced May 30, 2026
- FDA UDI 3279095b-9e49-4357-a486-41f4c79c225e 35 fields · synced May 30, 2026
- EUDAMED bd217a48-fe14-4f94-966d-7e4bfc25dda3 61 fields · synced Jul 10, 2026
- EUDAMED 3f80b778-5482-491a-9471-2ddc909da853 61 fields · synced Jul 16, 2026