Identity
- Trade Name
- Consensus Hip System FDA UDI
- Generic Name
- Uncoated femoral stem prosthesis, one-piece FDA UDI
- Device Name
- Distal Centralizer, 23mm FDA UDI
- Model / Reference
- 0009-0-0023 FDA UDI
- Description
- Distal Centralizer, 23mm FDA UDI
Identifiers
- Catalog Number
- 0009-0-0023 FDA UDI
- Primary DI / UDI-DI
- 00840286800709 FDA UDI
- FDA Product Code
- JDL FDA UDI
- GMDN Term
- Uncoated femoral stem prosthesis, one-piece FDA UDI
Classification
- Device Class
- Class III FDA UDI
- Regulation Number
- 888.3320 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
Yes
FDA UDI
Single Use
Yes
FDA UDI
Implantable
Yes
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
Yes
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: Uncoated femoral stem prosthesis, one-piece
Consensus Hip System by Shalby Advanced Technologies, Inc. — Class III — 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 III | Pending data |
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Manufacturer
- Manufacturer
- Shalby Advanced Technologies, Inc.
Sources (1)
- FDA UDI 8aabb852-210e-4a78-b0ed-2ba57326b80a 35 fields · synced May 30, 2026