Identity
- Trade Name
- Optetrak Logic FDA UDI
- Generic Name
- Knee femur prosthesis trial, reusable FDA UDI
- Device Name
- LOGIC STEM EXT TRIAL 18MM X 80MM FDA UDI
- Model / Reference
- 02-013-60-1880 FDA UDI
- Description
- LOGIC STEM EXT TRIAL 18MM X 80MM FDA UDI
Identifiers
- Catalog Number
- 02-013-60-1880 FDA UDI
- Primary DI / UDI-DI
- 10885862285669 FDA UDI
- FDA Product Code
- JWH FDA UDI
- GMDN Term
- Knee femur prosthesis trial, reusable FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 888.3560 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
Dimensions & Sizes
- Size
- Outer Diameter — 18 Millimeter FDA UDILength — 80 Millimeter FDA UDI
Optetrak Logic by Exactech, 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
- Exactech, Inc.
Sources (1)
- FDA UDI 5d07bbd9-973a-48d8-992f-244298a2f741 36 fields · synced Jun 1, 2026