HYPO3 Skin Cleanser Eczema Spray

GUDID 10735282400985

Skin Cleanser for Eczema Removes Germs from skin

MUNCHKIN, INC.

Antimicrobial wound irrigation solution, non-sterile
Primary Device ID10735282400985
NIH Device Record Key318e34f2-faf8-4545-80ef-f9f27151e9f4
Commercial Distribution StatusIn Commercial Distribution
Brand NameHYPO3 Skin Cleanser Eczema Spray
Version Model Number40098
Company DUNS787026855
Company NameMUNCHKIN, INC.
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usefalse
Lot Batchtrue
Serial Numberfalse
Manufacturing Datefalse
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptionfalse
OTC Over-The-Countertrue

Device Dimensions

Total Volume3.4 Fluid Ounce
Total Volume3.4 Fluid Ounce
Total Volume3.4 Fluid Ounce
Total Volume3.4 Fluid Ounce
Total Volume3.4 Fluid Ounce
Total Volume3.4 Fluid Ounce
Total Volume3.4 Fluid Ounce
Total Volume3.4 Fluid Ounce
Total Volume3.4 Fluid Ounce
Total Volume3.4 Fluid Ounce
Total Volume3.4 Fluid Ounce
Total Volume3.4 Fluid Ounce
Total Volume3.4 Fluid Ounce
Total Volume3.4 Fluid Ounce
Total Volume3.4 Fluid Ounce
Total Volume3.4 Fluid Ounce
Total Volume3.4 Fluid Ounce
Total Volume3.4 Fluid Ounce
Total Volume3.4 Fluid Ounce
Total Volume3.4 Fluid Ounce
Total Volume3.4 Fluid Ounce
Total Volume3.4 Fluid Ounce
Total Volume3.4 Fluid Ounce
Total Volume3.4 Fluid Ounce
Total Volume3.4 Fluid Ounce
Total Volume3.4 Fluid Ounce
Total Volume3.4 Fluid Ounce

Device Identifiers

Device Issuing AgencyDevice ID
GS100735282213090 [Package]
Contains: 00735282400988
Package: Unit [2 Units]
In Commercial Distribution
GS100735282400988 [Primary]
GS110735282213097 [Package]
Contains: 00735282213090
Package: Case [12 Units]
In Commercial Distribution
GS110735282400985 [Package]
Contains: 00735282400988
Package: Case [24 Units]
In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

FRODressing, Wound, Drug

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2022-09-02
Device Publish Date2022-08-25

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