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VADER® Pedicle System VADER® Pedicle System MIS-2-open Container, complete
EUDAMEDFDA UDIClass I (EU MDR)
Ref 42-870Model Container
by icotec ag
Identity
- Trade Name
- VADER® Pedicle System VADER® Pedicle System MIS-2-open Container, complete EUDAMEDVADER Pedicle System MIS-2-open, Container, complete FDA UDI
- Generic Name
- Device sterilization/disinfection container, reusable FDA UDI
- Device Name
- VADER Pedicle System MIS-2-open, Container, complete FDA UDI
- Model / Reference
- Container EUDAMED42-870 EUDAMEDFDA UDI
- Description
- VADER Pedicle System MIS-2-open, Container, complete FDA UDI
Identifiers
- Catalog Number
- 42-870 FDA UDI
- Primary DI / UDI-DI
- 07640172551431 EUDAMEDFDA UDI
- Basic UDI-DI
- 764017255iPSI0006AY EUDAMED
- Direct Marketing DI
- 07640172551431 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 UDI
Moist Heat or Steam Sterilization FDA UDI
VADER® Pedicle System VADER® Pedicle System MIS-2-open Container, complete by icotec AG — Class I — MDR, FDA UDI — listed in EUDAMED, FDA GUDID
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 (2)
- EUDAMED f26af4c8-1001-4dd6-93e9-d17371df8591 61 fields · synced May 30, 2026
- FDA UDI 253ea670-17c1-4e25-b88d-3983fd7091c7 35 fields · synced May 30, 2026