Catalog Number

-

Brand Name

McKesson

Version/Model Number

61-82022

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

-

Product Code

NAE

Product Code Name

Dressing, Wound, Hydrogel Without Drug And/Or Biologic

Public Device Record Key

0ec939d9-d56f-46d7-9475-eb7703b324a2

Public Version Date

June 19, 2020

Public Version Number

2

DI Record Publish Date

May 27, 2020

Package DI Number

00612479141117

Quantity per Package

4

Contains DI Package

00612479141100

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Case