Identity
- Trade Name
- Venus FDA UDI
- Generic Name
- Cervical total disc replacement prosthesis, non-sterile FDA UDI
- Device Name
- Venus Cervical Plate, Three Level, 77mm FDA UDI
- Model / Reference
- VCP377 FDA UDI
- Description
- Venus Cervical Plate, Three Level, 77mm FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00840916118594 FDA UDI
- FDA Product Code
- KWQ FDA UDI
- GMDN Term
- Cervical total disc replacement prosthesis, non-sterile FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 888.3060 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
No
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
Venus by Spinal Elements, Inc. — Class II — 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 II | Pending data |
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Manufacturer
- Manufacturer
- Spinal Elements, Inc.
Sources (1)
- FDA UDI 22348bc9-2a8e-4167-994d-291301df2977 34 fields · synced May 31, 2026