Duns Number:603420183
Device Description: COR-KNOT MINI® COMBO KITBase Package Type - KitEach sterile package kit contains (2) singl COR-KNOT MINI® COMBO KITBase Package Type - KitEach sterile package kit contains (2) single patient use COR-KNOT MINI® Devices and (12) COR-KNOT® QUICK LOADS®.Rotating shaft.
Catalog Number
031350
Brand Name
COR-KNOT MINI®
Version/Model Number
031350
Device Commercial Distribution Status
In Commercial Distribution
Commercial Distribution End Date
-
Issuing Agency
In GS1
MRI safety Status
MR Conditional
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
K100593,K100593
Product Code
HCF
Product Code Name
Instrument, Ligature Passing And Knot Tying
Public Device Record Key
83b839b8-ad3a-4f37-8440-99e6b6de9152
Public Version Date
July 16, 2020
Public Version Number
4
DI Record Publish Date
February 04, 2016
Package DI Number
10850200006299
Quantity per Package
6
Contains DI Package
00850200006292
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
Case
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 56 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 31 |