Duns Number:008162518
Device Description: K-Wire D. Trocar 4" 0.6mm [.024"] Ti Alloy pkg/1
Catalog Number
gS 79.2106
Brand Name
gSource
Version/Model Number
gS 79.2106
Device Commercial Distribution Status
In Commercial Distribution
Commercial Distribution End Date
-
Issuing Agency
In HIBCC
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
Yes
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
K030665
Product Code
HTY
Product Code Name
Pin, Fixation, Smooth
Public Device Record Key
8bb71322-e0e9-48a7-9217-55f09f7924f9
Public Version Date
July 26, 2021
Public Version Number
1
DI Record Publish Date
July 16, 2021
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 | 4617 |
2 | A medical device with a moderate to high risk that requires special controls. | 280 |