ScarMD

Basic Information

• Brand Name: ScarMD
• Primary DI: 00860004589730
• Version / Model: 3g
• Company Name: AIM MEDICAL INC.
• Labeler DUNS: 117589740
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2020-08-21
• Public Version: 1
• Public Version Date: 2020-08-31
• Public Version Status: New
• Public Device Record Key: a104de59-0133-45c3-b414-a0e6e0b220b6

Device Description

ScarMD Silicone Scar Gel 3g

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): No
• Over the Counter (OTC): No
• 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: Yes
• Has Serial Number: No
• Has Lot/Batch Number: No
• Has Manufacturing Date: No
• Has Expiration Date: No
• Has Donation ID: No

Sterilization

• Is Sterile: Yes
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
MDA	Elastomer, Silicone, For Scar Management	General, Plastic Surgery	878.4025	1

GMDN Terms

Code	Name	Definition	Implantable	Status
47772	Scar management dressing, single-use, sterile	A sterile covering made of, or coated with, a silicone-based substance (e.g., silicone gel) intended to be applied directly to the skin for the management of hypertrophic or keloid scars. The device is typically in the form of a flexible or elastic sheet that occludes the skin to hydrate and reduce red, dark, or raised scars resulting from surgery, accidents, cuts, burns, or other injuries. The device may be self-adhesive or fixed by tape. 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	00860004589730	GS1