Identity
- Trade Name
- BioBall™ FDA UDI
- Generic Name
- Diaphysis prosthesis FDA UDI
- Device Name
- BioBall Trial Adapter 12/14 (5°42') Neck S non-sterile FDA UDI
- Model / Reference
- HM40121 FDA UDI
- Description
- BioBall Trial Adapter 12/14 (5°42') Neck S non-sterile FDA UDI
Identifiers
- Primary DI / UDI-DI
- 04048266007599 FDA UDI
- FDA Product Code
- HWT FDA UDI
- GMDN Term
- Diaphysis prosthesis FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 888.4800 FDA UDI
- Commercial Distribution
- Not in Commercial Distribution FDA UDI
Clinical & Handling
Sterile
Yes
FDA UDI
Single Use
No
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
Yes
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
BioBall™ by Merete GmbH — Class I — 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 I | Pending data |
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Manufacturer
- Manufacturer
- Merete GmbH
Sources (1)
- FDA UDI ca766c0b-5f73-4900-bd65-3f35ead3fcd8 35 fields · synced Jun 1, 2026