Identity
- Trade Name
- OMNIMAX MMF SYSTEM FDA UDI
- Generic Name
- Device sterilization/disinfection container, reusable FDA UDI
- Model / Reference
- 46-2463 FDA UDI
Identifiers
- Catalog Number
- 46-2463 FDA UDI
- Primary DI / UDI-DI
- 00888233010009 FDA UDI
- FDA Product Code
- DZL FDA UDIJEY FDA UDI
- GMDN Term
- Device sterilization/disinfection container, reusable FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 872.4880 FDA UDI872.4760 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
No
FDA UDI
Implantable
No
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
No
FDA UDI
Manufacturing Date
No
FDA UDI
Moist Heat or Steam Sterilization FDA UDI
Category: Device sterilization/disinfection container, reusable
Omnimax Mmf System by Biomet Microfixation, Inc — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Cleared under the same submission
K143336 also covers:
- TRAUMAONE SYSTEM — BIOMET MICROFIXATION, INC
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- TraumaOne SYSTEM — BIOMET MICROFIXATION, INC
- TraumaOne SYSTEM — BIOMET MICROFIXATION, INC
- TraumaOne SYSTEM — BIOMET MICROFIXATION, INC
- TraumaOne SYSTEM — BIOMET MICROFIXATION, INC
- TraumaOne SYSTEM — BIOMET MICROFIXATION, INC
K202969 also covers:
- OMNIMAX — BIOMET MICROFIXATION, INC
- OMNIMAX — BIOMET MICROFIXATION, INC
- OMNIMAX — BIOMET MICROFIXATION, INC
- TraumaOne SYSTEM — BIOMET MICROFIXATION, INC
- TraumaOne SYSTEM — BIOMET MICROFIXATION, INC
- TraumaOne SYSTEM — BIOMET MICROFIXATION, INC
- TraumaOne SYSTEM — BIOMET MICROFIXATION, INC
- TraumaOne SYSTEM — BIOMET MICROFIXATION, INC
- TraumaOne SYSTEM — BIOMET MICROFIXATION, INC
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 ce5e099b-0356-4ca9-804e-d263a9c4d93b 35 fields · synced May 31, 2026