Catalog Number

-

Brand Name

McKesson

Version/Model Number

186-6542

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

-

Prescription Use (Rx)

-

Over the Counter (OTC)

-

Kit

-

Combination Product

-

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

-

FDA Premarket Submission

K150799,K150799

Product Code

FRO

Product Code Name

Dressing, Wound, Drug

Public Device Record Key

951fd6a7-a8fb-4381-a84b-6e3ce40414d8

Public Version Date

April 01, 2019

Public Version Number

1

DI Record Publish Date

March 22, 2019

Package DI Number

00612479232488

Quantity per Package

6

Contains DI Package

00612479232471

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Case