EltaMD Dermal Wound Cleanser

Basic Information

• Brand Name: EltaMD Dermal Wound Cleanser
• Primary DI: 00090205025311
• Version / Model: 02531
• Company Name: CP Skin Health Group, Inc.
• Labeler DUNS: 611921669
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2022-12-13
• Public Version: 3
• Public Version Date: 2023-06-22
• Public Version Status: Update
• Public Device Record Key: f1a0b83f-7de2-4505-a7fa-696662926434

Device Description

EltaMD® Dermal Wound Cleanser is intended for the removal of foreign material, such as debris and dirt, from dermal wounds.

Device Characteristics

• Single Use: No
• Prescription Use (Rx): No
• Over the Counter (OTC): Yes
• Kit: No
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: No
• MRI Safety: Labeling does not contain MRI Safety Information
• Direct Marking Exempt: No
• PM Exempt: No
• Has Serial Number: No
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: No
• Has Expiration Date: Yes
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
FRO	Dressing, Wound, Drug	Unknown		U

GMDN Terms

Code	Name	Definition	Implantable	Status
47156	Skin detergent	A non-dedicated chemical solution intended to be applied to the surface of the skin for cleaning and/or conditioning, and is commonly used to remove dirt, debris, peeling skin, and/or for the attenuation of minor skin disorders (e.g., dry skin). It contains a synthetic surfactant (e.g., sodium laureth sulfate) and is normally available [non-prescription] over-the-counter (OTC) for home-use. After application, this device cannot be reused.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00090205025311	GS1
Package	10090205025318	GS1	Case	6	In Commercial Distribution

Customer Contacts

• Phone: [phone]
• Email: [email protected]

Premarket Submissions

Submission Number	Supplement Number
K073610	000