Identity
- Trade Name
- BIOCERAM AZUL HEAD FDA UDI
- Generic Name
- Ceramic-on-polyethylene total hip prosthesis FDA UDI
- Device Name
- AZUL HEAD 26 +3.5 FDA UDI
- Model / Reference
- GMH04-400054 FDA UDI
- Description
- AZUL HEAD 26 +3.5 FDA UDI
Identifiers
- Catalog Number
- GMH04-400054 FDA UDI
- Primary DI / UDI-DI
- 04547898491191 FDA UDI
- FDA Product Code
- LZO FDA UDI
- GMDN Term
- Ceramic-on-polyethylene total hip prosthesis FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 888.3353 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
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
No
FDA UDI
Lot / Batch Number
No
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Ceramic-on-polyethylene total hip prosthesis
Bioceram Azul Head by Kyocera Corporation — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Also classified as Ceramic-on-polyethylene total hip prosthesis.
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- Conformis Hip System — Conformis, Inc. · Class II
- Modal Total Hip System — MODAL MANUFACTURING LLC · Class II
- United Hip System, U-Motion II PS Cup, Multi-Hole — UNITED ORTHOPEDIC CORP. · Class II
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- B-P TOTAL HIP SYSTEM — ENDOTEC, INC. · Class II
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
- Kyocera Corporation
Sources (1)
- FDA UDI f78d8642-da34-45d9-8a80-e08e3485c50f 36 fields · synced Jun 8, 2026