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VADER Pedicle System, Trial rod, flexible, Ø 5.5 mm +1 more model
FDA UDIEUDAMEDClass II (US FDA UDI)
by Icotec
Identity
- Trade Name
- VADER Pedicle System, Trial rod, flexible, Ø 5.5 mm; L = 300 mm FDA UDI
- Generic Name
- Surgical implant template, reusable FDA UDI
- Device Name
- VADER Pedicle System, Trial rod, flexible, Ø 5.5 mm; L = 300 mm FDA UDI
- Model / Reference
- 42-895 FDA UDI
- Description
- VADER Pedicle System, Trial rod, flexible, Ø 5.5 mm; L = 300 mm FDA UDI
Identifiers
- Catalog Number
- 42-895 FDA UDI
- Primary DI / UDI-DI
- 07640172551998 FDA UDI
- FDA Product Code
- NKB FDA UDIPML FDA UDI
- GMDN Term
- Surgical implant template, reusable FDA UDI
- Models / Variants
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 888.3070 FDA UDI888.3027 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: Surgical implant template, reusable
VADER Pedicle System, Trial rod, flexible, Ø 5.5 mm +1 more model by Icotec — Class II — MDR, FDA UDI — listed in FDA GUDID, EUDAMED — 2 models
Similar devices
Also classified as Surgical implant template, reusable.
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- VFT — Ldr Spine USA · Class II
- Tranquil-C™ — NEXUS SPINE, L.L.C. · Class I
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 1e513d51-a8d1-41b6-bb40-72697e47b20c 35 fields · synced Jun 18, 2026
- EUDAMED 1 fields · synced Jun 3, 2026