PLG

Basic Information

• Brand Name: PLG
• Primary DI: 07290016681314
• Version / Model: FS10009
• Catalog Number: FS10009
• Company Name: FORMATK SYSTEMS LTD
• Labeler DUNS: 532396673
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2017-08-18
• Public Version: 3
• Public Version Date: 2018-07-06
• Public Version Status: Update
• Public Device Record Key: 620ff0e0-f127-4a66-8ac7-2900087e84d1

Device Description

Peeling applicator to be used Formatk Systems Ltd supporting Systems for Microdermabrasion treatments

Device Characteristics

• Single Use: No
• 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: No
• Has Serial Number: Yes
• Has Lot/Batch Number: No
• 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
GFE	Brush, Dermabrasion, Powered	General, Plastic Surgery	878.4820	1

GMDN Terms

Code	Name	Definition	Implantable	Status
11177	Skin abrasion unit	A mains electricity (AC-powered) device used for the removal of the skin surface by abrasion (applied by some kind of rotating abrasive tool, e.g., a wire brush or emery disc). It may be used during plastic surgery and can be used for treatments such as the removal of scars, tattoos, pigmented nevi, fine wrinkles, or other irregularities of the skin. This GMDN code may reflect old technology.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	07290016681314	GS1

Premarket Submissions

Submission Number	Supplement Number
K160195	000