Catalog Number

FS2020

Brand Name

GORE BIO-A Tissue Reinforcement

Version/Model Number

FS2020

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"

-

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

OWT

Product Code Name

Mesh, surgical, absorbable, abdominal hernia

Public Device Record Key

3af9bbb1-a790-428b-9365-a3be75c5e7f6

Public Version Date

June 10, 2022

Public Version Number

10

DI Record Publish Date

February 13, 2017

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-