Catalog Number

-

Brand Name

Amerisource Bergen

Version/Model Number

10112

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)

Yes

Device labeled as "Not made with natural rubber latex"

-

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

KGO

Product Code Name

Surgeon'S Gloves

Public Device Record Key

efe8a8b1-580d-44f7-9906-109b257752dd

Public Version Date

April 20, 2022

Public Version Number

2

DI Record Publish Date

November 18, 2021

Package DI Number

60368001101129

Quantity per Package

4

Contains DI Package

00368001101127

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Case