Duns Number:807201207
Device Description: Tenodesis System Hex Driver
Catalog Number
86PS3066
Brand Name
G-FORCE
Version/Model Number
86PS3066
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
HWR
Product Code Name
DRIVER, PROSTHESIS
Public Device Record Key
4b72927e-2979-4314-a815-b7b733d5c011
Public Version Date
August 10, 2022
Public Version Number
5
DI Record Publish Date
September 17, 2016
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 | 1994 |
2 | A medical device with a moderate to high risk that requires special controls. | 5554 |