Catalog Number

-

Brand Name

AmerisourceBergen

Version/Model Number

10121

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

55e34d92-8154-4f90-a651-23bbfbc1b6bb

Public Version Date

December 08, 2021

Public Version Number

1

DI Record Publish Date

November 30, 2021

Package DI Number

60368001101211

Quantity per Package

4

Contains DI Package

00368001101219

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

case