Catalog Number

-

Brand Name

McKesson

Version/Model Number

14-168

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

K042952,K042952,K042952

Product Code

LYZ

Product Code Name

Vinyl Patient Examination Glove

Public Device Record Key

68d9d305-7c7f-4af3-91d3-2f1e5431608b

Public Version Date

October 22, 2018

Public Version Number

1

DI Record Publish Date

September 20, 2018

Package DI Number

00612479188082

Quantity per Package

20

Contains DI Package

00612479188075

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Case