Identity
- Trade Name
- RIBFIX BLU SYSTEM FDA UDI
- Generic Name
- General-purpose calliper, metallic FDA UDI
- Model / Reference
- 76-0005 FDA UDI
Identifiers
- Catalog Number
- 76-0005 FDA UDI
- Primary DI / UDI-DI
- 00841036184599 FDA UDI
- 510(k) Number
- K142823 FDA UDI
- FDA Product Code
- HRS FDA UDI
- GMDN Term
- General-purpose calliper, metallic FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 888.3030 FDA UDI
- Commercial Distribution
- Not 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
Ribfix Blu System by Biomet Microfixation, Inc — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Cleared under the same submission
K142823 also covers:
- RIBFIX ADVANTAGE — BIOMET MICROFIXATION, INC
- RIBFIX BLU ADVANTAGE — BIOMET MICROFIXATION, INC
- RIBFIX BLU ADVANTAGE — BIOMET MICROFIXATION, INC
- RIBFIX BLU SYSTEM — BIOMET MICROFIXATION, INC
- RIBFIX BLU SYSTEM — BIOMET MICROFIXATION, INC
- RIBFIX BLU SYSTEM — BIOMET MICROFIXATION, INC
- RIBFIX BLU SYSTEM — BIOMET MICROFIXATION, INC
- RIBFIX BLU SYSTEM — BIOMET MICROFIXATION, INC
- RIBFIX BLU SYSTEM — BIOMET MICROFIXATION, INC
- RIBFIX BLU SYSTEM — BIOMET MICROFIXATION, INC
- RIBFIX BLU SYSTEM — BIOMET MICROFIXATION, INC
- RIBFIX BLU 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 93c8e142-70ff-4cc9-8d9f-95c075d23c99 36 fields · synced Jun 1, 2026