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®.
Catalog Number
-
Brand Name
COR-KNOT MINI®
Version/Model Number
031350
Device Commercial Distribution Status
Not in Commercial Distribution
Commercial Distribution End Date
July 15, 2020
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
5b396434-96c7-4d8b-a70a-44b3c0ce1880
Public Version Date
July 16, 2020
Public Version Number
4
DI Record Publish Date
December 04, 2015
Package DI Number
10850200006084
Quantity per Package
6
Contains DI Package
00850200006087
Package Discontinue Date
August 29, 2016
Package Status
Not 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 |