Identity
- Trade Name
- CervAlign Anterior Cervical Plate System FDA UDI
- Generic Name
- Device sterilization/disinfection container, reusable FDA UDI
- Device Name
- 4-LVL PLATE CADDY FDA UDI
- Model / Reference
- 66-4LVL-PLATE-CAD FDA UDI
- Description
- 4-LVL PLATE CADDY FDA UDI
Identifiers
- Catalog Number
- 66-4LVL-PLATE-CAD FDA UDI
- Primary DI / UDI-DI
- 00846468000189 FDA UDI
- FDA Product Code
- LRP FDA UDI
- GMDN Term
- Device sterilization/disinfection container, reusable FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 878.4800 FDA UDI
- Commercial Distribution
- Not in Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
Yes
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
Yes
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
Moist Heat or Steam Sterilization FDA UDI
CervAlign Anterior Cervical Plate System by Xtant Medical Holdings, Inc. — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Authorization Coverage (1 country)
Regulatory Authorizations
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
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Manufacturer
- Manufacturer
- Xtant Medical Holdings, Inc.
Sources (1)
- FDA UDI 1d0a61a9-20c7-4ba3-bd1f-b5552c55227d 36 fields · synced May 30, 2026