Identity
- Trade Name
- OTOMIMIX FDA UDI
- Generic Name
- Orthopaedic cement, non-antimicrobial FDA UDI
- Model / Reference
- 7014-3266 FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00841036141943 FDA UDI
- 510(k) Number
- K042516 FDA UDI
- FDA Product Code
- NEA FDA UDI
- GMDN Term
- Orthopaedic cement, non-antimicrobial FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 872.3275 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
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
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
Otomimix by Biomet Microfixation, Inc — 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
- Biomet Microfixation, Inc
Sources (1)
- FDA UDI fdf7023e-beb0-4383-92b3-5f2678c3bcf3 36 fields · synced Jun 6, 2026