Catalog Number

-

Brand Name

McKesson

Version/Model Number

1721

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

NAE

Product Code Name

Dressing, Wound, Hydrogel Without Drug And/Or Biologic

Public Device Record Key

14a10875-1129-4684-a270-159ae150de2e

Public Version Date

April 17, 2020

Public Version Number

1

DI Record Publish Date

April 09, 2020

Package DI Number

00612479193291

Quantity per Package

30

Contains DI Package

00612479193284

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Case