Kelo-cote Advanced Formula Scar Gel

Basic Information

• Brand Name: Kelo-cote Advanced Formula Scar Gel
• Primary DI: 00070030511753
• Version / Model: Lot Code
• Company Name: Alliance Pharma Inc.
• Labeler DUNS: 081138954
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2024-04-10
• Public Version: 1
• Public Version Date: 2024-04-18
• Public Version Status: New
• Public Device Record Key: 937ee246-0b39-4e12-b2a0-73f1c5735d6f

Device Description

Kelo-cote Advanced Formula Scar Gel 60g

Device Characteristics

• Single Use: Yes
• 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: Yes
• Has Serial Number: No
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: No
• Has Expiration Date: No
• Has Donation ID: No

Sterilization

• Is Sterile: No
• 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
47771	Scar-management dressing, single-use	A covering/substance made of, or coated with, a synthetic polymer material (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/film, foam, or gel that occludes the skin to hydrate and reduce/prevent red, dark, or raised scars resulting from surgery, accidents, cuts, burns, or other injuries. The device may be self-adhesive or fixed by tape; devices/accessories associated with application may be included (e.g., massage ball). 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	00070030511753	GS1