Catalog Number

-

Brand Name

McKesson

Version/Model Number

14-140

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)

-

Kit

-

Combination Product

-

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

-

FDA Premarket Submission

-

Product Code

LYZ

Product Code Name

Vinyl Patient Examination Glove

Public Device Record Key

2bda9752-8d9b-4e92-8495-ca82658fe111

Public Version Date

July 02, 2020

Public Version Number

1

DI Record Publish Date

June 24, 2020

Package DI Number

00612479185708

Quantity per Package

10

Contains DI Package

00612479185692

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Case