Duns Number:040729840
Device Description: NITINOL K WIRE TROCAR PIN WITH ROUND END
Catalog Number
-
Brand Name
NITINOL K WIRE TROCAR PIN
Version/Model Number
1106-719
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
902d7f1d-ae88-4c1d-bc12-161f679a15f0
Public Version Date
December 04, 2018
Public Version Number
2
DI Record Publish Date
August 22, 2018
Package DI Number
10192896001746
Quantity per Package
1
Contains DI Package
00192896001749
Package Discontinue Date
December 03, 2018
Package Status
Not 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 |