Ultravision2 Generator

Basic Information

• Brand Name: Ultravision2 Generator
• Primary DI: 05060417680412
• Version / Model: DPD-006-001
• Catalog Number: DPD-006-001
• Company Name: ALESI SURGICAL LIMITED
• Labeler DUNS: 219516254
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2023-12-13
• Public Version: 1
• Public Version Date: 2023-12-21
• Public Version Status: New
• Public Device Record Key: efb8ed2c-a591-4719-808d-054140861ae7

Device Description

The Ultravision2 System/Generator is designed to integrate surgical smoke clearing technology with the electrosurgical and ultrasonic systems that are used in electrosurgery. The UV2 Generator provides an interface between commercially available electrosurgical generators and electrosurgical instruments. The intention is to provide a system that enables the synchronization of Ionwand activation to clear the visual field with the energy output from electrosurgical or ultrasonic devices that generate the surgical smoke.

Device Characteristics

• Single Use: No
• Prescription Use (Rx): Yes
• 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
PQM	Surgical Smoke Precipitator	General, Plastic Surgery	878.5050	2

GMDN Terms

Code	Name	Definition	Implantable	Status
60836	Laparoscopic plume filter	A sterile device intended to be used during minimally-invasive surgery, in particular laparoscopic surgery, to filter surgical smoke (plume created by, e.g., electrosurgical diathermy, a laser or sonic scalpel) of potentially harmful agents (e.g., noxious chemicals, particulates, viruses, bacteria) without loss of pneumoperitoneum. It is typically a multi-layered filter pouch intended to be connected to a trocar stopcock; it is intended to help protect surgical staff from ambient exposure to potentially harmful agents. This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Package	15060417680419	GS1	Box	1	In Commercial Distribution
Primary	05060417680412	GS1

Customer Contacts

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

Premarket Submissions

Submission Number	Supplement Number
K231238	000