Catalog Number

-

Brand Name

McKesson

Version/Model Number

16-3001

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"

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

-

Product Code

GAG

Product Code Name

Stapler, Surgical

Public Device Record Key

16fa7fe6-b9ca-4d29-96a2-5d145ebf600e

Public Version Date

March 10, 2021

Public Version Number

2

DI Record Publish Date

July 16, 2020

Package DI Number

20612479214785

Quantity per Package

10

Contains DI Package

10612479214801

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Box