Catalog Number

8844XL

Brand Name

CARDINAL HEALTH

Version/Model Number

8844XL

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

K093375,K093375,K093375

Product Code

LYY

Product Code Name

Latex patient examination glove

Public Device Record Key

7600b08b-bd0b-4909-bdc9-37efdd97b050

Public Version Date

June 19, 2020

Public Version Number

2

DI Record Publish Date

January 30, 2019

Package DI Number

50885380134812

Quantity per Package

10

Contains DI Package

00885380134817

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

CASE