Identity
- Trade Name
- DEXA-C CERVICAL INTERBODY SYSTEM FDA UDI
- Generic Name
- Sterilization packaging, single-use FDA UDI
- Device Name
- Dexa-C Implant Overbox, Yellow FDA UDI
- Model / Reference
- 116-701-2 FDA UDI
- Description
- Dexa-C Implant Overbox, Yellow FDA UDI
Identifiers
- Primary DI / UDI-DI
- B52111670120 FDA UDI
- FDA Product Code
- FSM FDA UDI
- GMDN Term
- Sterilization packaging, single-use FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 878.4800 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
Yes
FDA UDI
Single Use
Yes
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
No
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
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Sterilization packaging, single-use
Dexa-C Cervical Interbody System by Aurora Spine, Inc. — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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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
- Aurora Spine, Inc.
Sources (1)
- FDA UDI bb3bf4e8-8e7a-4bcf-afe3-675d97096c58 34 fields · synced Jun 6, 2026