Cellfina System Cart

Basic Information

• Brand Name: Cellfina System Cart
• Primary DI: 00840763101015
• Version / Model: Rev R
• Catalog Number: 1010103
• Company Name: ULTHERA, INC.
• Labeler DUNS: 010981554
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2019-03-08
• Public Version: 1
• Public Version Date: 2019-03-18
• Public Version Status: New
• Public Device Record Key: c95b9b5f-3d9b-4eaa-8513-1ebf828785ab

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: 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
OUP	Powered Surgical Instrument For Improvement In The Appearance Of Cellulite	General, Plastic Surgery	878.4790	2

GMDN Terms

Code	Name	Definition	Implantable	Status
38664	Operating table accessory trolley	A cart typically designed as a framework on wheels with baskets, shelves, hooks and organizers that is used to store the operating table accessories in an orderly and hygienic manner. This trolley (cart) may be brought into the operation room (OR) so that a choice of operating table accessories, or accessories for a specific surgical procedure is made readily available.	No	Obsolete

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00840763101015	GS1

Premarket Submissions

Submission Number	Supplement Number
K161885	000