Catalog Number

FP0616

Brand Name

GORE BIO-A Fistula Plug

Version/Model Number

FP0616

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

K083266

Product Code

FTL

Product Code Name

Mesh, surgical, polymeric

Public Device Record Key

d14e66c0-4569-4293-8f52-f8d6f763e11e

Public Version Date

June 10, 2022

Public Version Number

5

DI Record Publish Date

February 13, 2017

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-