Catalog Number

-

Brand Name

McKesson

Version/Model Number

4960

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)

Yes

Over the Counter (OTC)

-

Kit

-

Combination Product

-

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

-

FDA Premarket Submission

K181197,K181197,K181197

Product Code

FRO

Product Code Name

Dressing, Wound, Drug

Public Device Record Key

13508037-a51e-4ef0-a88d-de3805deb9e4

Public Version Date

June 19, 2020

Public Version Number

2

DI Record Publish Date

April 12, 2019

Package DI Number

00612479243293

Quantity per Package

10

Contains DI Package

00612479243286

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Case