Identity
- Trade Name
- BioBall™ Adapter FDA UDI
- Generic Name
- Femoral head/stem prosthesis adaptor FDA UDI
- Model / Reference
- 12/14 (5°42') M FDA UDI
Identifiers
- Catalog Number
- HM30122 FDA UDI
- Primary DI / UDI-DI
- 04048266025494 FDA UDI
- FDA Product Code
- LZO FDA UDI
- GMDN Term
- Femoral head/stem prosthesis adaptor 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
BioBall™ Adapter 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 9d72d7c4-47d1-452b-b1e8-4e1446cec5cb 36 fields · synced May 30, 2026