AccessGUDID - DEVICE: Qoustic Choice® Wound Therapy System Converter Hand Piece (00853077002145)

GUDID

Device Identifier (DI) Information

Brand Name: Qoustic Choice® Wound Therapy System Converter Hand Piece
Version or Model: AR1000D
Commercial Distribution Status: In Commercial Distribution
Catalog Number: AR1000D-H/P
Company Name: AROBELLA MEDICAL, LLC

Primary DI Number: 00853077002145
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 839978876 *Terms of Use

Device Description: Hand Piece, Converter, Qoustic Choice® Wound Therapy System, Model AR1000D Series

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?
44750	Soft-tissue ultrasonic surgical system handpiece, reusable	A hand-held component of an ultrasonic surgical system intended to convert high frequency electrical current from a generator into an ultrasonic oscillation for a tip placed at its end to mechanically fragment soft-tissue cells upon contact for cutting and/or coagulating tissue during surgery. The handpiece may also serve as a conduit for irrigation and aspiration during surgery. It is typically in the form of a pen/pencil or elongated probe with permanently attached cables. This is a non-dedicated device intended to be used in multiple clinical specialties. This is a reusable device.	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 [?]
Liquid Chemical
Moist Heat or Steam Sterilization

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: 1 Pound
Height: 6 Inch
Width: 12 Inch
Depth: 12 Inch

Device Record Status

Public Device Record Key: 3f97fa25-8c75-498e-aa68-9cd9d53768b1
Public Version Date: August 06, 2018
Public Version Number: 3
DI Record Publish Date: March 01, 2017