Duns Number:932637023
Device Description: Smooth K-Wire, Single Trocar Tip; .035" DIA x 5" LG; Material: 316L Stainless Steel
Catalog Number
TK-035-5S
Brand Name
Simpex Kirschner Wire
Version/Model Number
TK-035-5S
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
K911505
Product Code
HTY
Product Code Name
Pin, Fixation, Smooth
Public Device Record Key
ac5a1a83-aeec-4c29-be01-1773da10c5df
Public Version Date
July 06, 2018
Public Version Number
3
DI Record Publish Date
September 23, 2015
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 | 25 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 168 |