Identity
- Trade Name
- BioBall DELTA™ Ceramic Head FDA UDI
- Generic Name
- Ceramic femoral head prosthesis FDA UDI
- Model / Reference
- 36 FDA UDI
Identifiers
- Catalog Number
- HM50036 FDA UDI
- Primary DI / UDI-DI
- 04048266025470 FDA UDI
- FDA Product Code
- LZO FDA UDI
- GMDN Term
- Ceramic femoral head prosthesis FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 888.3353 FDA UDI
- Commercial Distribution
- Not 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
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
Dimensions & Sizes
- Size
- Outer Diameter — 36 Millimeter FDA UDI
BioBall DELTA™ Ceramic Head by Merete GmbH — 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
- Merete GmbH
Sources (1)
- FDA UDI cc1a808f-9f7a-4ff6-8c73-287b820f6d91 36 fields · synced Jun 1, 2026