Catalog Number

-

Brand Name

Titan SGS Standard Gastric Stapler

Version/Model Number

SGS23R

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In GS1

MRI safety Status

MR Conditional

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"

Yes

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

K210278,K210278

Product Code

GAG

Product Code Name

Stapler, Surgical

Public Device Record Key

1c5dd88f-07f0-4692-8544-01d489b320aa

Public Version Date

August 26, 2021

Public Version Number

1

DI Record Publish Date

August 18, 2021

Package DI Number

20851677007083

Quantity per Package

3

Contains DI Package

00851677007089

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-