Catalog Number

-

Brand Name

Amerisource Bergen

Version/Model Number

10802

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)

-

Over the Counter (OTC)

Yes

Kit

-

Combination Product

-

Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)

-

FDA Premarket Submission

-

Product Code

QQS

Product Code Name

Stapler, Skin

Public Device Record Key

70455a0a-57ca-4b9a-8ca8-086ad11a1f16

Public Version Date

August 11, 2022

Public Version Number

3

DI Record Publish Date

November 18, 2021

Package DI Number

20368001108021

Quantity per Package

5

Contains DI Package

00368001108027

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Inner Box