Catalog Number

-

Brand Name

McKesson

Version/Model Number

37-6220

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

September 30, 2023

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)

Yes

Kit

-

Combination Product

-

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

-

FDA Premarket Submission

K083042

Product Code

FRO

Product Code Name

Dressing, Wound, Drug

Public Device Record Key

2798a869-e5a4-494d-9f64-42167b336cd7

Public Version Date

February 21, 2022

Public Version Number

3

DI Record Publish Date

April 24, 2020

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-