Catalog Number

-

Brand Name

HYPO3 Skin Cleanser Daily Diaper Rash Spray

Version/Model Number

40099

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

K160095,K160095,K160095,K160095

Product Code

FRO

Product Code Name

Dressing, Wound, Drug

Public Device Record Key

64cfd791-bc02-4ab8-8bf6-91872a76864b

Public Version Date

September 02, 2022

Public Version Number

1

DI Record Publish Date

August 25, 2022

Package DI Number

10735282400992

Quantity per Package

24

Contains DI Package

00735282400995

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Case