Catalog Number

-

Brand Name

McKesson

Version/Model Number

20-2565N

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

KGO

Product Code Name

Surgeon'S Gloves

Public Device Record Key

96af8f69-adb7-4c49-b823-23ee2e9e18c6

Public Version Date

April 15, 2020

Public Version Number

1

DI Record Publish Date

April 07, 2020

Package DI Number

00612479212077

Quantity per Package

4

Contains DI Package

00612479212060

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Case