Qoustic Wound Therapy System® Qoustic Key®

Basic Information

• Brand Name: Qoustic Wound Therapy System® Qoustic Key®
• Primary DI: 00853077002121
• Version / Model: AR1000B/D
• Catalog Number: AR1000-KEY
• 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: 3
• Public Version Date: 2018-08-06
• Public Version Status: Update
• Public Device Record Key: 77d0a7bb-9f33-4aa7-bc3c-3b1b25ed49b4

Device Description

Qoustic Key®, Qoustic Wound Therapy System®, Model AR1000 Series, for systems set as (M) to use Pre-Paid Minutes (PPM)

Device Characteristics

• Single Use: Yes
• 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: No
• 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
NRB	Wound Cleaner, Ultrasound	General, Plastic Surgery	878.4410	2
LFL	Instrument, Ultrasonic Surgical	Unknown		U

GMDN Terms

Code	Name	Definition	Implantable	Status
44778	Soft-tissue ultrasonic surgical system	An assembly of devices that converts high frequency current into ultrasonic oscillation to mechanically fragment soft-tissue cells upon contact with a vibrating tip for cutting and/or coagulating tissue during surgery, possibly in combination with irrigation and aspiration. Ongoing vibration may create heat in cells (diathermy) to increase the cutting/coagulating capacity. It typically includes an energy-producing generator with monitoring functions, a handpiece(s) with tip(s) to convert and apply the energy, connecting cables, a foot-switch as an option to regulate the energy, and possibly an integrated irrigation/suction system.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00853077002121	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	0.1	Pound
Height	1.6	Inch
Width	4	Inch
Depth	6	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