Identity
- Trade Name
- MINIRAIL FDA UDI
- Generic Name
- External orthopaedic fixation system, single-use FDA UDI
- Device Name
- Mini-Fix Wave Washer FDA UDI
- Model / Reference
- 983-1000-10 FDA UDI
- Description
- Mini-Fix Wave Washer FDA UDI
Identifiers
- Catalog Number
- 983-1000-10 FDA UDI
- Primary DI / UDI-DI
- 00886385013350 FDA UDI
- FDA Product Code
- KTT FDA UDI
- GMDN Term
- External orthopaedic fixation system, single-use 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
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
No
FDA UDI
Manufacturing Date
No
FDA UDI
Moist Heat or Steam Sterilization FDA UDI
Minirail by Stryker Corp. — 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
- Stryker Corp.
Sources (1)
- FDA UDI f2ec3a71-b4ef-4a9a-876e-42588d3f6f7b 35 fields · synced Jun 1, 2026