AccessGUDID - DEVICE: Qoustic Wound Therapy System®, Model AR1000 Series (00853077002008)

GUDID

Device Identifier (DI) Information

Brand Name: Qoustic Wound Therapy System®, Model AR1000 Series
Version or Model: AR1000
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number: AR1000-SYS
Company Name: AROBELLA MEDICAL, LLC

Primary DI Number: 00853077002008
Issuing Agency: GS1
Commercial Distribution End Date: March 01, 2017
Device Count: 1
Labeler D-U-N-S® Number*: 839978876 *Terms of Use

Device Description: Qoustic Wound Therapy System®, Model AR1000 Series - ultrasound wound therapy system for wound debridement and management

Device Characteristics

What MRI safety information does the labeling contain?	Labeling does not contain MRI Safety Information
Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437):	No
Device labeled as "Not made with natural rubber latex":	Yes
For Single-Use:	No
Prescription Use (Rx):	Yes
Over the Counter (OTC):	No
Kit:	No
Combination Product:	No
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P):	No

GMDN

[?]

GMDN Term Code	GMDN Term Name	GMDN Term Definition	GMDN Term Status [?]	Implantable?
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.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
NRB	Wound Cleaner, Ultrasound
LFL	Instrument, Ultrasonic Surgical

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K062544	000
K131096	000

Device Exempt from Premarket Submission: No CLOSE

Sterilization

Device Packaged as Sterile: No
Requires Sterilization Prior to Use: Yes

Sterilization Method [?]
High-level Disinfectant
Moist Heat or Steam Sterilization
Liquid Chemical

Storage and Handling

[?]

Storage and Handling
Storage Environment Temperature: between -20 and 50 Degrees Celsius
Storage Environment Humidity: between 0 and 90 Percent (%) Relative Humidity
Handling Environment Humidity: between 0 and 90 Percent (%) Relative Humidity

Clinically Relevant Size

[?]

Size Type Text
Weight: 23 Pound
Height: 12.25 Inch
Width: 19.5 Inch
Depth: 20.625 Inch

Device Record Status

Public Device Record Key: 18353640-2414-4f6d-b2ea-8f8d698285df
Public Version Date: August 06, 2018
Public Version Number: 3
DI Record Publish Date: March 01, 2017