Duns Number:249225954
Device Description: AnchorKnot Suture Passer (2-0); AnchorKnot Knot Pusher (2-0); AnchorKnot Suture Cutter (2- AnchorKnot Suture Passer (2-0); AnchorKnot Knot Pusher (2-0); AnchorKnot Suture Cutter (2-0)
Catalog Number
-
Brand Name
AnchorKnot Tissue Approximation Kit
Version/Model Number
PSZ-400-312
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)
Yes
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
K161878
Product Code
HRX
Product Code Name
Arthroscope
Public Device Record Key
e666444e-a2c7-4320-a0db-bb157f3561b7
Public Version Date
July 06, 2018
Public Version Number
3
DI Record Publish Date
November 30, 2016
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 |
|---|---|---|
| 2 | A medical device with a moderate to high risk that requires special controls. | 1139 |