Catalog Number

-

Brand Name

Dakin's Wound Cleanser Pro 16oz w/ cap

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

K150208,K150208

Product Code

FRO

Product Code Name

Dressing, Wound, Drug

Public Device Record Key

bcd502d2-9463-4a47-af4c-50b45626be34

Public Version Date

September 28, 2022

Public Version Number

1

DI Record Publish Date

September 20, 2022

Package DI Number

00304365312830

Quantity per Package

8

Contains DI Package

00304365301612

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

carton