Identity
- Trade Name
- GALAXY FIXATION GEMINI FDA UDI
- Generic Name
- Orthopaedic trocar blade, reusable FDA UDI
- Device Name
- GALAXY FIXATION GEMINI SCREW GUIDE FDA UDI
- Model / Reference
- 1 FDA UDI
- Description
- GALAXY FIXATION GEMINI SCREW GUIDE FDA UDI
Identifiers
- Catalog Number
- 194500 FDA UDI
- Primary DI / UDI-DI
- 18052469472583 FDA UDI
- FDA Product Code
- LXH FDA UDI
- GMDN Term
- Orthopaedic trocar blade, reusable FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 888.4540 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
Yes
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Moist Heat or Steam Sterilization FDA UDI
MR Conditional FDA UDI
Category: Orthopaedic trocar blade, reusable
Galaxy Fixation Gemini by Orthofix, Inc. — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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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 I | Pending data |
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Manufacturer
- Manufacturer
- Orthofix, Inc.
Sources (1)
- FDA UDI dc8c85fa-f299-4198-8648-10b685608b5e 35 fields · synced Jun 8, 2026