Catalog Number

MX6740

Brand Name

Mynx Ace Vascular Closure Device (6F/7F)

Version/Model Number

MX6740

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

bfbb464e-d81a-4103-a6e7-053ddad57f08

Public Version Date

August 10, 2022

Public Version Number

8

DI Record Publish Date

February 06, 2017

Package DI Number

M465MX67401

Quantity per Package

10

Contains DI Package

M465MX67400

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Box