Identity
- Trade Name
- OMNIMAX FDA UDI
- Generic Name
- Orthopaedic bone wire FDA UDI
- Model / Reference
- 01-5824 FDA UDI
Identifiers
- Catalog Number
- 01-5824 FDA UDI
- Primary DI / UDI-DI
- 00841036274719 FDA UDI
- FDA Product Code
- HTY FDA UDIJEY FDA UDIDZL FDA UDI
- GMDN Term
- Orthopaedic bone wire FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 888.3040 FDA UDI872.4760 FDA UDI872.4880 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
Yes
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
MR Conditional FDA UDI
Category: Orthopaedic bone wire
Omnimax 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
K202969 also covers:
- OMNIMAX — BIOMET MICROFIXATION, INC
- OMNIMAX — BIOMET MICROFIXATION, INC
- OMNIMAX MMF 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
- TraumaOne SYSTEM — BIOMET MICROFIXATION, INC
K831005 also covers:
- EXTERNAL DISTRACTION SYSTEM — BIOMET MICROFIXATION, INC
- EXTERNAL DISTRACTION SYSTEM — BIOMET MICROFIXATION, INC
- EXTERNAL DISTRACTION SYSTEM — BIOMET MICROFIXATION, INC
- EXTERNAL DISTRACTION SYSTEM — BIOMET MICROFIXATION, INC
- LIGATURE WIRE — BIOMET MICROFIXATION, INC
- LIGATURE WIRE — BIOMET MICROFIXATION, INC
- OMNIMAX — BIOMET MICROFIXATION, INC
- .062 X 8" GUIDE WIRE — Biomet Orthopedics, Inc.
- .062" DIA X 8" LONG — Biomet Orthopedics, Inc.
- 1.6MM X 150MM GUIDE WIRE — Biomet Orthopedics, Inc.
- 2.0MM X 250MM NON THD GUIDE WIRE — Biomet Orthopedics, Inc.
- 3.0MMX250MM NON THD GUIDE WIRE — Biomet Orthopedics, 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 610c5089-4b95-46bb-b945-8d5110fdda55 35 fields · synced May 30, 2026