Identity
- Trade Name
- CervAlign Anterior Cervical Plate System FDA UDI
- Generic Name
- Fluted surgical drill bit, reusable FDA UDI
- Device Name
- CERVALIGN, Ø2.0x10mm DRILL FDA UDI
- Model / Reference
- 725-104 FDA UDI
- Description
- CERVALIGN, Ø2.0x10mm DRILL FDA UDI
Identifiers
- Catalog Number
- 725-104 FDA UDI
- Primary DI / UDI-DI
- 00846468094331 FDA UDI
- FDA Product Code
- HTW FDA UDI
- GMDN Term
- Fluted surgical drill bit, reusable FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 888.4540 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 Pioneer Surgical Technology, 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
- Pioneer Surgical Technology, Inc.
Sources (1)
- FDA UDI 0a2ac0c2-524c-480c-b173-9ca60fdc376e 37 fields · synced Jun 1, 2026