Catalog Number

-

Brand Name

McKesson

Version/Model Number

37-6291

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)

Yes

Kit

-

Combination Product

-

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

-

FDA Premarket Submission

K083042,K083042

Product Code

FRO

Product Code Name

Dressing, Wound, Drug

Public Device Record Key

ed171fca-c937-45f6-8133-353209d2d10c

Public Version Date

June 09, 2022

Public Version Number

2

DI Record Publish Date

May 12, 2021

Package DI Number

00612479228405

Quantity per Package

6

Contains DI Package

00612479240162

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Case