Catalog Number

HP02

Brand Name

GORE BIO-A Hernia Plug

Version/Model Number

HP02

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

K033671

Product Code

OWT

Product Code Name

Mesh, surgical, absorbable, abdominal hernia

Public Device Record Key

f4b3022e-5b15-4cfd-9547-9eae705fed11

Public Version Date

June 10, 2022

Public Version Number

6

DI Record Publish Date

February 13, 2017

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-