EltaMD Enzyme HydroGel 3oz

GUDID 00827854001119

CP Skin Health Group, Inc.

Wound hydrogel dressing, non-antimicrobial Wound hydrogel dressing, non-antimicrobial Wound hydrogel dressing, non-antimicrobial Wound hydrogel dressing, non-antimicrobial Wound hydrogel dressing, non-antimicrobial Wound hydrogel dressing, non-antimicrobial Wound hydrogel dressing, non-antimicrobial Wound hydrogel dressing, non-antimicrobial Wound hydrogel dressing, non-antimicrobial Wound hydrogel dressing, non-antimicrobial Wound hydrogel dressing, non-antimicrobial Wound hydrogel dressing, non-antimicrobial Wound hydrogel dressing, non-antimicrobial Wound hydrogel dressing, non-antimicrobial Wound hydrogel dressing, non-antimicrobial Wound hydrogel dressing, non-antimicrobial Wound hydrogel dressing, non-antimicrobial

• Primary Device ID: 00827854001119
• NIH Device Record Key: c67c3e02-7b67-4526-9cde-b09a4128a349
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: EltaMD Enzyme HydroGel 3oz
• Version Model Number: 04000
• Company DUNS: 611921669
• Company Name: CP Skin Health Group, Inc.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: true
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: false
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: false
• OTC Over-The-Counter: true

Customer Support Contacts

• Phone: 1-800-633-8872
• Email: xx@xx.xx
• Phone: 1-800-633-8872
• Email: xx@xx.xx
• Phone: 1-800-633-8872
• Email: xx@xx.xx
• Phone: 1-800-633-8872
• Email: xx@xx.xx
• Phone: 1-800-633-8872
• Email: xx@xx.xx
• Phone: 1-800-633-8872
• Email: xx@xx.xx
• Phone: 1-800-633-8872
• Email: xx@xx.xx
• Phone: 1-800-633-8872
• Email: xx@xx.xx
• Phone: 1-800-633-8872
• Email: xx@xx.xx
• Phone: 1-800-633-8872
• Email: xx@xx.xx
• Phone: 1-800-633-8872
• Email: xx@xx.xx
• Phone: 1-800-633-8872
• Email: xx@xx.xx
• Phone: 1-800-633-8872
• Email: xx@xx.xx
• Phone: 1-800-633-8872
• Email: xx@xx.xx
• Phone: 1-800-633-8872
• Email: xx@xx.xx
• Phone: 1-800-633-8872
• Email: xx@xx.xx
• Phone: 1-800-633-8872
• Email: xx@xx.xx

Device Identifiers

Device Issuing Agency	Device ID
GS1	00827854001119 [Primary]
GS1	10827854001116 [Package]; Package: Case [12 Units]; In Commercial Distribution

FDA Product Code

• NAE: Dressing, Wound, Hydrogel Without Drug And/Or Biologic

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2024-02-01
• Device Publish Date: 2024-01-24

Devices Manufactured by CP Skin Health Group, Inc.

• 00827854001119 - EltaMD Enzyme HydroGel 3oz: 2024-02-01
• 00827854001119 - EltaMD Enzyme HydroGel 3oz: 2024-02-01
• 00827854009832 - EltaMD SilverGel 1.5 oz: 2024-02-01