| Primary Device ID | 00810005667845 |
| NIH Device Record Key | 3a9224b2-d803-453b-92cb-4f0a09366a38 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Radian MIS Bunion System |
| Version Model Number | BUN-1000C-104 |
| Company DUNS | 047486041 |
| Company Name | NVISION BIOMEDICAL TECHNOLOGIES, INC. |
| Device Count | 1 |
| DM Exempt | false |
| Pre-market Exempt | false |
| MRI Safety Status | Labeling does not contain MRI Safety Information |
| Human Cell/Tissue Product | false |
| Device Kit | false |
| Device Combination Product | false |
| Single Use | false |
| Lot Batch | true |
| Serial Number | false |
| Manufacturing Date | false |
| Expiration Date | false |
| Donation Id Number | false |
| Contains Natural Rubber Latex | false |
| Labeled No Natural Rubber Latex | false |
| RX Perscription | true |
| OTC Over-The-Counter | false |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00810005667845 [Primary] |
| LRP | Tray, Surgical |
| Steralize Prior To Use | true |
| Device Is Sterile | false |
[00810005667845]
Moist Heat or Steam Sterilization
[00810005667845]
Moist Heat or Steam Sterilization
[00810005667845]
Moist Heat or Steam Sterilization
[00810005667845]
Moist Heat or Steam Sterilization
[00810005667845]
Moist Heat or Steam Sterilization
[00810005667845]
Moist Heat or Steam Sterilization
[00810005667845]
Moist Heat or Steam Sterilization
[00810005667845]
Moist Heat or Steam Sterilization
[00810005667845]
Moist Heat or Steam Sterilization
[00810005667845]
Moist Heat or Steam Sterilization
[00810005667845]
Moist Heat or Steam Sterilization
[00810005667845]
Moist Heat or Steam Sterilization
[00810005667845]
Moist Heat or Steam Sterilization
[00810005667845]
Moist Heat or Steam Sterilization
[00810005667845]
Moist Heat or Steam Sterilization
[00810005667845]
Moist Heat or Steam Sterilization
[00810005667845]
Moist Heat or Steam Sterilization
[00810005667845]
Moist Heat or Steam Sterilization
[00810005667845]
Moist Heat or Steam Sterilization
[00810005667845]
Moist Heat or Steam Sterilization
[00810005667845]
Moist Heat or Steam Sterilization
[00810005667845]
Moist Heat or Steam Sterilization
[00810005667845]
Moist Heat or Steam Sterilization
[00810005667845]
Moist Heat or Steam Sterilization
[00810005667845]
Moist Heat or Steam Sterilization
[00810005667845]
Moist Heat or Steam Sterilization
[00810005667845]
Moist Heat or Steam Sterilization
[00810005667845]
Moist Heat or Steam Sterilization
[00810005667845]
Moist Heat or Steam Sterilization
[00810005667845]
Moist Heat or Steam Sterilization
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2022-02-08 |
| Device Publish Date | 2022-01-31 |
| 00810005667852 | Tray: MIS Bunion K-Wire Tube. The Radian MIS Bunion System is intended for fixation of osteoto |
| 00810005667845 | Tray: MIS Bunion Caddy Lid. The Radian MIS Bunion System is intended for fixation of osteotomi |
| 00810005667838 | Tray: MIS Bunion Caddy Base. The Radian MIS Bunion System is intended for fixation of osteotom |
| 00810005667821 | Tray: MIS Bunion Tray Lid. The Radian MIS Bunion System is intended for fixation of osteotomie |
| 00810005667814 | Tray: MIS Bunion Tray Base. The Radian MIS Bunion System is intended for fixation of osteotomi |
| 00810005663861 | Instrument: Small Olive Pin. The Radian MIS Bunion System is intended for fixation of osteotom |
| 00810005663854 | Instrument: Depth Gauge tool. The Radian MIS Bunion System is intended for fixation of osteoto |
| 00810005663847 | Instrument: Olive Pin. The Radian MIS Bunion System is intended for fixation of osteotomies an |
| 00810005663830 | Instrument: 3.0mm Diameter Drill. The Radian MIS Bunion System is intended for fixation of ost |
| 00810005663823 | Instrument: Drill Guide. The Radian MIS Bunion System is intended for fixation of osteotomies |
| 00810005665704 | 5.0mm Correction L-Bunion Plate. The Radian MIS Bunion System is intended for fixation of osteo |
| 00810005669344 | 3.0mm Correction L-Bunion Plate. The Radian MIS Bunion System is intended for fixation of osteo |