Duns Number:132286761
Device Description: MynxGrip Vascular Closure Device (6F/7F)
Catalog Number
MX6721
Brand Name
MynxGrip Vascular Closure Device (6F/7F)
Version/Model Number
MX6721
Device Commercial Distribution Status
In Commercial Distribution
Commercial Distribution End Date
-
Issuing Agency
In HIBCC
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
P040044,P040044
Product Code
MGB
Product Code Name
Device, Hemostasis, Vascular
Public Device Record Key
bf7b3d29-a95d-4679-a8fd-8fe5823fa7bc
Public Version Date
August 10, 2022
Public Version Number
8
DI Record Publish Date
February 06, 2017
Package DI Number
M465MX67211
Quantity per Package
10
Contains DI Package
M465MX67210
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
Box
Device Class | Device Class Description | No of Devices |
---|---|---|
2 | A medical device with a moderate to high risk that requires special controls. | 1 |
3 | A medical device with high risk that requires premarket approval | 2 |