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External Fixator Sterilization box large standard
FDA UDIClass II (US FDA UDI)
by Gexfix Sa
Identity
- Trade Name
- External Fixator Sterilization box large standard FDA UDI
- Generic Name
- General external orthopaedic fixation system implantation kit, reusable FDA UDI
- Device Name
- Reusable external orthopaedic fixation system sterilization box. FDA UDI
- Model / Reference
- 6010-1000 FDA UDI
- Description
- Reusable external orthopaedic fixation system sterilization box. FDA UDI
Identifiers
- Primary DI / UDI-DI
- 07640136270538 FDA UDI
- 510(k) Number
- K052605 FDA UDI
- FDA Product Code
- KTT FDA UDI
- GMDN Term
- General external orthopaedic fixation system implantation kit, reusable FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 888.3030 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
No
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
Category: General external orthopaedic fixation system implantation kit, reusable
External Fixator Sterilization box large standard by Gexfix Sa — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Cleared under the same submission
K052605 also covers:
- External Fixator Carbon Ring Ø 160 — GEXFIX SA
- External Fixator Carbon Tube 15x150 — GEXFIX SA
- External Fixator Carbon ring Ø 200 — GEXFIX SA
- External Fixator Carbon rod 9x110 — GEXFIX SA
- External Fixator Carbon rod 9x150 — GEXFIX SA
- External Fixator Carbon rod 9x200 — GEXFIX SA
- External Fixator Carbon rod 9x70 — GEXFIX SA
- External Fixator Carbon rod 9x90 — GEXFIX SA
- External Fixator Carbon tube 15x100 — GEXFIX SA
- External Fixator Carbon tube 15x125 — GEXFIX SA
- External Fixator Carbon tube 15x200 — GEXFIX SA
- External Fixator Carbon tube 15x250 — GEXFIX SA
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 |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Gexfix Sa
Sources (1)
- FDA UDI caf43f29-9f91-48df-a627-94343fbbfb59 34 fields · synced Jun 1, 2026