Catalog Number

1702503806

Brand Name

GORE-TEX Cardiovascular Patch

Version/Model Number

1702503806

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

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

K912107

Product Code

DXZ

Product Code Name

Patch, Pledget And Intracardiac, Petp, Ptfe, Polypropylene

Public Device Record Key

fc6e63a2-113f-4a78-a017-36fc31a90250

Public Version Date

November 08, 2021

Public Version Number

6

DI Record Publish Date

January 27, 2017

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-