Catalog Number

-

Brand Name

WoundClenz 8 oz w/ sprayer

Version/Model Number

1

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"

-

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

K090791,K090791

Product Code

FRO

Product Code Name

Dressing, Wound, Drug

Public Device Record Key

25cbb0d9-7b15-41f4-a176-518388b1a450

Public Version Date

September 28, 2022

Public Version Number

1

DI Record Publish Date

September 20, 2022

Package DI Number

00304361006436

Quantity per Package

8

Contains DI Package

00304361008089

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

carton