Zaffiro IR Treatment Applicator

Basic Information

• Brand Name: Zaffiro IR Treatment Applicator
• Primary DI: 00850017374065
• Version / Model: ZIR
• Catalog Number: 300-1104
• Company Name: NEAUVIA NORTH AMERICA, INC.
• Labeler DUNS: 117030786
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2020-09-14
• Public Version: 2
• Public Version Date: 2021-05-13
• Public Version Status: Update
• Public Device Record Key: 0ae2ba00-ca62-45f7-8781-4f1abcecaf3e

Device Description

Applicator to perform a non-invasive, thermo-lifting with the Zaffiro System

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: Yes
• PM Exempt: Yes
• Has Serial Number: Yes
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: Yes
• Has Expiration Date: Yes
• Has Donation ID: Yes

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
32388	Dermabrasion brush, rotary	A device with wire bristles that is rotated in a power-driven tool to 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
Primary	00850017374065	GS1

Customer Contacts

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