Cellfina System Disposable Tray

Basic Information

• Brand Name: Cellfina System Disposable Tray
• Primary DI: 00840763100407
• Version / Model: CK1 Rev. I
• Company Name: ULTHERA, INC.
• Labeler DUNS: 010981554
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2016-09-07
• Public Version: 2
• Public Version Date: 2018-03-29
• Public Version Status: Update
• Public Device Record Key: 4dd40f62-cf8d-40d2-9d10-2f9176266109

Device Characteristics

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

Sterilization

• Is Sterile: Yes
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
OUP	Powered Surgical Instrument For Improvement In The Appearance Of Cellulite	General, Plastic Surgery	878.4790	2

GMDN Terms

Code	Name	Definition	Implantable	Status
62248	Mechanical skin contouring system injection/transection set	A collection of sterile components of a mechanical skin contouring system intended to temporarily minimize the manifestation of cellulite by transection of the cellulite-tethering fibrous tissue by motorized mechanical means. It consists of template plates, needle and microblade assemblies to guide instruments, and a vacuum-assisted capture unit to control the tissue being treated. The device is placed on the skin, an area of skin/subcutaneous tissue is drawn by suction into a dome, and local anaesthesia is infiltrated prior to subcutaneous transection by a motorized cutting tool. This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00840763100407	GS1