Catalog Number

-

Brand Name

McKesson

Version/Model Number

20-2090

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

077d8ba4-6866-4ceb-ab18-2d8ac643dc2a

Public Version Date

September 09, 2022

Public Version Number

1

DI Record Publish Date

September 01, 2022

Package DI Number

40612479174106

Quantity per Package

4

Contains DI Package

20612479174027

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Case