EltaMD Enzyme HydroGel 3oz

GUDID 00827854001119

CP Skin Health Group, Inc.

Wound hydrogel dressing, non-antimicrobial
Primary Device ID00827854001119
NIH Device Record Keyc67c3e02-7b67-4526-9cde-b09a4128a349
Commercial Distribution StatusIn Commercial Distribution
Brand NameEltaMD Enzyme HydroGel 3oz
Version Model Number04000
Company DUNS611921669
Company NameCP Skin Health Group, Inc.
Device Count1
DM Exemptfalse
Pre-market Exempttrue
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

Customer Support Contacts

Phone1-800-633-8872
Emailxx@xx.xx
Phone1-800-633-8872
Emailxx@xx.xx
Phone1-800-633-8872
Emailxx@xx.xx
Phone1-800-633-8872
Emailxx@xx.xx
Phone1-800-633-8872
Emailxx@xx.xx
Phone1-800-633-8872
Emailxx@xx.xx
Phone1-800-633-8872
Emailxx@xx.xx
Phone1-800-633-8872
Emailxx@xx.xx
Phone1-800-633-8872
Emailxx@xx.xx
Phone1-800-633-8872
Emailxx@xx.xx
Phone1-800-633-8872
Emailxx@xx.xx
Phone1-800-633-8872
Emailxx@xx.xx
Phone1-800-633-8872
Emailxx@xx.xx
Phone1-800-633-8872
Emailxx@xx.xx
Phone1-800-633-8872
Emailxx@xx.xx
Phone1-800-633-8872
Emailxx@xx.xx
Phone1-800-633-8872
Emailxx@xx.xx

Device Identifiers

Device Issuing AgencyDevice ID
GS100827854001119 [Primary]
GS110827854001116 [Package]
Package: Case [12 Units]
In Commercial Distribution

FDA Product Code

NAEDressing, Wound, Hydrogel Without Drug And/Or Biologic

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2024-02-01
Device Publish Date2024-01-24

Devices Manufactured by CP Skin Health Group, Inc.

00827854001119 - EltaMD Enzyme HydroGel 3oz2024-02-01
00827854001119 - EltaMD Enzyme HydroGel 3oz2024-02-01
00827854009832 - EltaMD SilverGel 1.5 oz2024-02-01

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