Catalog Number

MX5021

Brand Name

MYNXGRIP

Version/Model Number

MX5021

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In GS1

MRI safety Status

MR Safe

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"

Yes

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

916eb695-b63c-44ae-8e13-664632b1ab75

Public Version Date

August 10, 2022

Public Version Number

9

DI Record Publish Date

August 23, 2017

Package DI Number

20862028000400

Quantity per Package

10

Contains DI Package

10862028000403

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

BOX