Duns Number:047486041
Device Description: Instrument: Depth Gauge tool. The Radian MIS Bunion System is intended for fixation of o Instrument: Depth Gauge tool. The Radian MIS Bunion System is intended for fixation of osteotomies and corrective procedures of the hallux and associated disorders such as hallux valgus.
Catalog Number
-
Brand Name
Radian MIS Bunion System
Version/Model Number
BUN-1001T-DPG
Device Commercial Distribution Status
In Commercial Distribution
Commercial Distribution End Date
-
Issuing Agency
In GS1
MRI safety Status
Labeling does not contain MRI Safety Information
Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437)
-
Device labeled as "Not made with natural rubber latex"
-
For Single-Use
-
Prescription Use (Rx)
Yes
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
-
Product Code
MDM
Product Code Name
Instrument, Manual, Surgical, General Use
Public Device Record Key
203205f6-1af3-485a-bd02-969a79e4250b
Public Version Date
February 08, 2022
Public Version Number
1
DI Record Publish Date
January 31, 2022
Package DI Number
None
Quantity per Package
-
Contains DI Package
-
Package Discontinue Date
-
Package Status
-
Package Type
-
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 461 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 1046 |