Dermal Cooling System

Basic Information

• Brand Name: Dermal Cooling System
• Primary DI: 00850019947847
• Version / Model: M1-TIP3-10
• Catalog Number: M1-TIP3-10
• Company Name: R2 DERMATOLOGY INC.
• Labeler DUNS: 080023734
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 10
• Record Status: Published
• Publish Date: 2023-06-09
• Public Version: 1
• Public Version Date: 2023-06-19
• Public Version Status: New
• Public Device Record Key: 7b8bf972-0e60-4ff1-8519-95a3e12bd27b

Device Description

Dermal Cooling System dermabrasion tip

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): Yes
• 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: Yes
• Has Manufacturing Date: Yes
• 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
GED	BRUSH, DERMABRASION, MANUAL	General, Plastic Surgery	878.4800	1

GMDN Terms

Code	Name	Definition	Implantable	Status
35760	Dermabrasion brush, manual	A hand-operated device with wire bristles that is used to manually plane the skin (surgical removal of the epidermis and as much of the dermis as necessary) to remove scars, tattoos, pigmented nevi, fine wrinkles, or other irregularities. This is a reusable device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Unit of Use	00850019947632	GS1
Primary	00850019947847	GS1

Customer Contacts

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