VADER® Pedicle System Safety Sleeve
EUDAMEDFDA UDIClass IIa (EU MDR)
by icotec ag
Identity
- Trade Name
- VADER® Pedicle System Safety Sleeve EUDAMEDVADER Pedicle System, Safety Sleeve FDA UDI
- Generic Name
- Orthopaedic implantation sleeve, reusable FDA UDI
- Device Name
- VADER Pedicle System, Safety Sleeve FDA UDI
- Model / Reference
- Safety Sleeve EUDAMED42-658 EUDAMEDFDA UDI
- Description
- VADER Pedicle System, Safety Sleeve FDA UDI
Identifiers
- Catalog Number
- 42-658 FDA UDI
- Primary DI / UDI-DI
- 07640164844381 EUDAMEDFDA UDI
- Basic UDI-DI
- 764017255iPSI0048BG EUDAMED
- Direct Marketing DI
- 07640164844381 EUDAMED
- FDA Product Code
- NKB FDA UDI
- EMDN Code
- L1109 NEUROSURGERY AND SPINAL SURGERY INSTRUMENT KITS, REUSABLE EUDAMED
- GMDN Term
- Orthopaedic implantation sleeve, 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
Single Use
No
Implantable
No
Reusable
No
Contains Latex
No
Reprocessed
No
CMR Substance
No
Human-derived
No
Human Tissues
No
Animal Tissues
No
Endocrine Disruptor
No
Administering Medicine
No
Measuring Function
No
Incorporates Medicinal Product
No
Prescription Use
Yes
Over-the-Counter
No
Convenience Kit
No
Combination Product
No
HCT/P
No
Premarket Exempt
No
Lot / Batch Number
Yes
Serial Number
No
Expiration Date
No
Manufacturing Date
Yes
Category: Device sterilization/disinfection container, reusable
VADER® Pedicle System Safety Sleeve by icotec AG — Class IIa — MDR, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
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Authorization Coverage (2 countries)
Regulatory Authorizations
CE/MDR
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | 764017255iPSI0048BG | 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 475d4692-8739-4f83-a8da-ab33f5188485 61 fields · synced Jul 13, 2026
- FDA UDI 72406ec5-967d-433a-83e8-a33ade006a0e 35 fields · synced May 30, 2026