LipiVage®

Basic Information

• Brand Name: LipiVage®
• Primary DI: 00818257020029
• Version / Model: D11-0290-109
• Company Name: GENESIS BIOSYSTEMS, INC.
• Labeler DUNS: 067933700
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2017-04-21
• Public Version: 3
• Public Version Date: 2023-06-08
• Public Version Status: Update
• Public Device Record Key: 12950e1f-131a-49b7-b224-0a242f134862

Device Description

LipiVage Harvester with cannula

Device Characteristics

• Single Use: Yes
• 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: Yes
• Has Serial Number: No
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: No
• 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
MUU	System, Suction, Lipoplasty	General, Plastic Surgery	878.5040	2
QKL	Lipoaspirate Washing System For Aesthetic Body Contouring	General, Plastic Surgery	878.5040	2

GMDN Terms

Code	Name	Definition	Implantable	Status
35390	Irrigation syringe	A general-purpose device used primarily for the flushing of body orifices with an irrigating solution. It may be designed with (e.g., a rigid plastic barrel with a fitted rubber bulb at one end and a nozzle at the other). This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00818257020029	GS1

Customer Contacts

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