Duns Number:040729840
Device Description: K WIRE TROCAR PIN ROUND with ROUND END 500MM X 1.3MM
Catalog Number
-
Brand Name
K WIRE ROUND END PIN
Version/Model Number
1106-717
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
Yes
Prescription Use (Rx)
-
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
K100736,K100736,K100736
Product Code
HTY
Product Code Name
Pin, Fixation, Smooth
Public Device Record Key
3e7e26d2-00d1-4ac8-bada-fac255205758
Public Version Date
January 04, 2019
Public Version Number
2
DI Record Publish Date
August 22, 2018
Package DI Number
10192896001739
Quantity per Package
5
Contains DI Package
00192896001732
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
Inner Pack
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 10108 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 3414 |