Catalog Number

20055721

Brand Name

GORE SEAMGUARD Bioabsorbable Staple Line Reinforce

Version/Model Number

20055721

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

K181940,K181940,K181940

Product Code

OXC

Product Code Name

Mesh, Surgical, Absorbable, Staple Line Reinforcement

Public Device Record Key

90660428-4899-427a-8afa-4f2e9759d20c

Public Version Date

June 10, 2022

Public Version Number

5

DI Record Publish Date

August 31, 2018

Package DI Number

00733132644766

Quantity per Package

12

Contains DI Package

00733132644780

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

BX