Catalog Number

1MVP402

Brand Name

GORE PRECLUDE MVP Dura Substitute

Version/Model Number

1MVP402

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

May 31, 2016

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

-

Product Code

GXQ

Product Code Name

Dura Substitute

Public Device Record Key

8285dd56-a9dd-496e-a0ae-0f00e08c7449

Public Version Date

November 09, 2021

Public Version Number

4

DI Record Publish Date

April 29, 2016

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-