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VADER Pedicle System, Dilator Navigated, Ø 13.0 mm
FDA UDIEUDAMEDClass II (US FDA UDI)
by Icotec
Identity
- Trade Name
- VADER Pedicle System, Dilator Navigated, Ø 13.0 mm FDA UDI
- Generic Name
- Fascial tissue dilator, reusable FDA UDI
- Device Name
- VADER Pedicle System, Dilator Navigated, Ø 13.0 mm FDA UDI
- Model / Reference
- 42-647N FDA UDI
- Description
- VADER Pedicle System, Dilator Navigated, Ø 13.0 mm FDA UDI
Identifiers
- Catalog Number
- 42-647N FDA UDI
- Primary DI / UDI-DI
- 07640172552407 FDA UDI
- FDA Product Code
- OLO FDA UDI
- GMDN Term
- Fascial tissue dilator, reusable FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 882.4560 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
No
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
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
Category: Fascial tissue dilator, reusable
VADER Pedicle System, Dilator Navigated, Ø 13.0 mm by Icotec — Class II — MDR, FDA UDI — listed in FDA GUDID, EUDAMED — regulatory data on deviCERTS
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- NVM5 — Nuvasive, Inc. · Class II
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Unknown
MDR
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | MDR | — | Class II | Unknown |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class II | Pending data |
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Manufacturer
- Manufacturer
- Icotec
Sources (2)
- FDA UDI 014f4dfa-b639-4237-974d-53b66b926e37 35 fields · synced Jun 19, 2026
- EUDAMED 1 fields · synced Jun 5, 2026