Duns Number:243880700
Device Description: 5" Double Trocar, 0.062" diameter-pkg-6
Catalog Number
SU78.2090
Brand Name
Batrik K-Wire & Steinman Pins
Version/Model Number
SU78.2090
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"
Yes
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
K100736
Product Code
HTY
Product Code Name
Pin, Fixation, Smooth
Public Device Record Key
f0eaa9aa-ce35-446f-a89a-f6cc25a93692
Public Version Date
July 06, 2018
Public Version Number
4
DI Record Publish Date
March 30, 2017
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 | 748 |
2 | A medical device with a moderate to high risk that requires special controls. | 20 |