Qoustic Choice® Wound Therapy System Ultrasonic Generator

Basic Information

• Brand Name: Qoustic Choice® Wound Therapy System Ultrasonic Generator
• Primary DI: 00853077002244
• Version / Model: AR1000D
• Catalog Number: AR1000D-GEN
• Company Name: AROBELLA MEDICAL, LLC
• Labeler DUNS: 839978876
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2017-03-01
• Public Version: 4
• Public Version Date: 2018-09-24
• Public Version Status: Update
• Public Device Record Key: f59550bd-16c8-42c1-9536-061cf4d72c18

Device Description

Ultrasonic Generator, Qoustic Choice® Wound Therapy System, Model AR1000D Series

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: Yes
• 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: Yes
• Sterilization Methods: Liquid Chemical

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
NRB	Wound Cleaner, Ultrasound	General, Plastic Surgery	878.4410	2
LFL	Instrument, Ultrasonic Surgical	Unknown		U

GMDN Terms

Code	Name	Definition	Implantable	Status
36273	Ultrasonic surgical system generator	An electrically-powered component of an ultrasonic surgical system intended to generate a high frequency electrical current that is converted, typically within a handpiece, into an ultrasonic oscillation to fragment hard and/or soft tissue cells upon contact with a vibrating tip. It is used in a variety of surgical disciplines (e.g., arthroscopy, gynaecology, neurosurgery, dental/craniomaxillofacial reconstructive surgery); it is not dedicated to dental applications. It provides the controls and monitoring functions for the system during the procedure, and typically regulates energy to the system via a foot-switch; integrated suction/aspiration function may be included.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00853077002244	GS1

Customer Contacts

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

Premarket Submissions

Submission Number	Supplement Number
K062544	000
K131096	000

Device Sizes

Type	Value	Unit	Text
Weight	18	Pound
Height	12.25	Inch
Width	19.5	Inch
Depth	20.625	Inch

Storage Conditions

• Type: Storage Environment Temperature
• Temperature Range: -20 – 50 Degrees Celsius
• Type: Storage Environment Humidity
• Temperature Range: 0 – 90 Percent (%) Relative Humidity
• Type: Handling Environment Humidity
• Temperature Range: 0 – 90 Percent (%) Relative Humidity