Catalog Number

1MYMP16

Brand Name

GORE MYCROMESH PLUS Biomaterial

Version/Model Number

1MYMP16

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

January 15, 2018

Issuing Agency

In GS1

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

K063435

Product Code

FTL

Product Code Name

Mesh, Surgical, Polymeric

Public Device Record Key

1a938335-e8bc-488f-bbad-2a07898f057f

Public Version Date

October 21, 2020

Public Version Number

4

DI Record Publish Date

March 07, 2016

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-