Identity
- Trade Name
- Radian MIS Bunion System FDA UDI
- Generic Name
- Surgical instrument/implant rack FDA UDI
- Device Name
- Tray: MIS Bunion Tray Lid. The Radian MIS Bunion System is intended for fixation of osteotomies and corrective procedures of the hallux and associated disorders such as hallux valgus. FDA UDI
- Model / Reference
- BUN-1000C-102 FDA UDI
- Description
- Tray: MIS Bunion Tray Lid. The Radian MIS Bunion System is intended for fixation of osteotomies and corrective procedures of the hallux and associated disorders such as hallux valgus. FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00810005667821 FDA UDI
- FDA Product Code
- LRP FDA UDI
- GMDN Term
- Surgical instrument/implant rack FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 878.4800 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
No
FDA UDI
Moist Heat or Steam Sterilization FDA UDI
Category: Surgical instrument/implant rack
Radian MIS Bunion System by Nvision Biomedical Technologies, 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
- Nvision Biomedical Technologies, Inc
Sources (1)
- FDA UDI 2ab09d92-93e7-42c0-8291-71acdf96a6b0 34 fields · synced May 31, 2026