EltaMD SilverGel 1.5 oz

GUDID 00827854009832

CP Skin Health Group, Inc.

Wound hydrogel dressing, antimicrobial

• Primary Device ID: 00827854009832
• NIH Device Record Key: 994e3061-8ca1-41d3-8f7f-8a175d16dda4
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: EltaMD SilverGel 1.5 oz
• Version Model Number: 03900
• Company DUNS: 611921669
• Company Name: CP Skin Health Group, Inc.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: true
• Single Use: false
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: true
• 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: 1800-633-8872
• Email: xx@xx.xx
• Phone: 1800-633-8872
• Email: xx@xx.xx
• Phone: 1800-633-8872
• Email: xx@xx.xx
• Phone: 1800-633-8872
• Email: xx@xx.xx
• Phone: 1800-633-8872
• Email: xx@xx.xx
• Phone: 1800-633-8872
• Email: xx@xx.xx
• Phone: 1800-633-8872
• Email: xx@xx.xx
• Phone: 1800-633-8872
• Email: xx@xx.xx
• Phone: 1800-633-8872
• Email: xx@xx.xx
• Phone: 1800-633-8872
• Email: xx@xx.xx
• Phone: 1800-633-8872
• Email: xx@xx.xx
• Phone: 1800-633-8872
• Email: xx@xx.xx
• Phone: 1800-633-8872
• Email: xx@xx.xx
• Phone: 1800-633-8872
• Email: xx@xx.xx
• Phone: 1800-633-8872
• Email: xx@xx.xx
• Phone: 1800-633-8872
• Email: xx@xx.xx
• Phone: 1800-633-8872
• Email: xx@xx.xx

Device Identifiers

Device Issuing Agency	Device ID
GS1	00827854009832 [Primary]
GS1	10827854009839 [Package]; Package: Case [12 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K071703

FDA Product Code

• FRO: Dressing, Wound, Drug

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
• 00827854009832 - EltaMD SilverGel 1.5 oz: 2024-02-01
• 00827854009832 - EltaMD SilverGel 1.5 oz: 2024-02-01