Home GUDID 10853077002203 Qoustic Choice® Wound Therapy System, Disposable Tubing Set
Primary DI 10853077002203
Brand Qoustic Choice® Wound Therapy System, Disposable Tubing Set
Company AROBELLA MEDICAL, LLC
Model AR1000D
Catalog number AR1000D-DTS
Device description Disposable Tubing Set, Qoustic Choice® Wound Therapy System, Model AR1000D Series
Published 2017-01-20
Public version status Update
Distribution status In Commercial Distribution
MRI safety Labeling does not contain MRI Safety Information
Rx true
OTC false
Sterile true
Single use true Product Codes# Code, Name table Code Name NRB Wound Cleaner, Ultrasound
Product Code Classifications# Code, Device, Specialty table Code Device Specialty Class NRB Wound Cleaner, Ultrasound General, Plastic Surgery 2
Identifiers And Packaging# Identifier, Type, Agency table Identifier Type Agency Package quantity Status 00853077002190 Package GS1 50 In Commercial Distribution 00853077002206 Package GS1 6 In Commercial Distribution 10853077002203 Package GS1 12 In Commercial Distribution 00853077002183 Primary GS1 0
Alternate GTIN / UPC / EAN Codes Source identifier, GTIN-14 normalized, UPC-A table Source identifier GTIN-14 normalized UPC-A EAN-13 00853077002190 00853077002190 853077002190 0853077002190 00853077002206 00853077002206 853077002206 0853077002206 10853077002203 10853077002203 00853077002183 00853077002183 853077002183 0853077002183
GMDN Terms# Term, Definition table Term Definition 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.
Device Sizes# Type, Value, Unit table Type Value Unit Depth 7.9 Inch
Storage And Handling# Type, Low, High table Type Low High Condition Handling Environment Humidity 0 Percent (%) Relative Humidity 90 Percent (%) Relative Humidity
Sterilization Methods# Method table Method Ethylene Oxide
Regulatory Flags# DUNS number 839978876 Device count 1 DM exempt false Premarket exempt false HCT/P false Kit false Combination product false Lot or batch false Serial number false Manufacturing date on label false Expiration date on label false Donation ID number false Contains natural rubber latex false No natural rubber latex true Sterilization required before use true Other Devices From This Company# Primary DI, Brand, Model table Primary DI Brand Model Catalog Published 00853077002220 Qoustic Wound Therapy System® Ultrasonic Generator AR1000 AR1000-GEN 2017-03-01 00853077002237 Qoustic Wound Therapy System® Ultrasonic Generator AR1000B AR1000B-GEN 2017-03-01 00853077002244 Qoustic Choice® Wound Therapy System Ultrasonic Generator AR1000D AR1000D-GEN 2017-03-01 00853077002183 Qoustic Choice® Wound Therapy System, Disposable Tubing Set AR1000D AR1000D-DTS 2017-01-20 00853077002008 Qoustic Wound Therapy System®, Model AR1000 Series AR1000 AR1000-SYS 2017-03-01 00853077002015 Qoustic Wound Therapy System® Converter Hand Piece AR1000 AR1000-H/P 2017-03-01 00853077002022 Qoustic Wound Therapy System®, Cart, AR Series, Type 1, Support AR1000 AR1000-CRT1A 2017-03-01 00853077002039 Qoustic Wound Therapy System®, Cart, AR Series, Type 1, Base AR1000 AR1000-CRT1B 2017-03-01 00853077002060 Qoustic Wound Therapy System®, Qoustic Qurette® Probe, Type 1 AR1000/B AR1000-QT1 2017-03-01 00853077002077 Qoustic Wound Therapy System®, Model AR1000B Series AR1000B AR1000B-SYS 2017-03-01 00853077002091 Qoustic Wound Therapy System®, Qoustic Qurette® Probe, Type 4 AR1000/B AR1000-QT4 2017-03-01 00853077002107 Qoustic Wound Therapy System®, Qoustic Qurette® Probe, Type 6 AR1000/B AR1000-QT6 2017-03-01 00853077002114 Qoustic Wound Therapy System®, Qoustic Qurette® Probe, Type 7 AR1000/B AR1000-QT7 2017-03-01 00853077002121 Qoustic Wound Therapy System® Qoustic Key® AR1000B/D AR1000-KEY 2017-03-01 00853077002138 Qoustic Choice® Wound Therapy System, Model AR1000D Series AR1000D AR1000D-SYS 2017-03-01 00853077002145 Qoustic Choice® Wound Therapy System Converter Hand Piece AR1000D AR1000D-H/P 2017-03-01 00853077002152 Qoustic Wound Therapy System®, Qoustic Qurette® Probe, Type 11 AR1000D AR1000D-QT11 2017-03-01 00853077002169 Qoustic Wound Therapy System®, Qoustic Qurette® Probe, Type 12 AR1000D AR1000D-QT12 2017-03-01 00853077002176 Qoustic Wound Therapy System®, Qoustic Qurette® Probe, Type 13 AR1000D AR1000D-QT13 2017-03-01 00853077002213 Qoustic Wound Therapy System®, Qoustic Qurette® Probe, Type 14 AR1000D AR1000D-QT14 2017-03-01
Other Devices Sharing Product Codes# Primary DI, Brand, Company table Primary DI Brand Company Product code Published 00812265010317 UltraMIST Generator SANUWAVE Health, Inc. NRB 2021-01-25 00812265010324 UltraMIST Treatment Wand SANUWAVE Health, Inc. NRB 2021-01-25 00812265010331 UltraMIST Single Use Applicator SANUWAVE Health, Inc. NRB 2021-01-25 00812265010348 UltraMIST Single Use Applicator (12 Pack) SANUWAVE Health, Inc. NRB 2021-01-25 00853077002008 Qoustic Wound Therapy System®, Model AR1000 Series AROBELLA MEDICAL, LLC NRB 2017-03-01 00853077002015 Qoustic Wound Therapy System® Converter Hand Piece AROBELLA MEDICAL, LLC NRB 2017-03-01 00853077002022 Qoustic Wound Therapy System®, Cart, AR Series, Type 1, Support AROBELLA MEDICAL, LLC NRB 2017-03-01 00853077002039 Qoustic Wound Therapy System®, Cart, AR Series, Type 1, Base AROBELLA MEDICAL, LLC NRB 2017-03-01 00853077002060 Qoustic Wound Therapy System®, Qoustic Qurette® Probe, Type 1 AROBELLA MEDICAL, LLC NRB 2017-03-01 00853077002077 Qoustic Wound Therapy System®, Model AR1000B Series AROBELLA MEDICAL, LLC NRB 2017-03-01 00853077002091 Qoustic Wound Therapy System®, Qoustic Qurette® Probe, Type 4 AROBELLA MEDICAL, LLC NRB 2017-03-01 00853077002107 Qoustic Wound Therapy System®, Qoustic Qurette® Probe, Type 6 AROBELLA MEDICAL, LLC NRB 2017-03-01 00853077002114 Qoustic Wound Therapy System®, Qoustic Qurette® Probe, Type 7 AROBELLA MEDICAL, LLC NRB 2017-03-01 00853077002121 Qoustic Wound Therapy System® Qoustic Key® AROBELLA MEDICAL, LLC NRB 2017-03-01 00853077002138 Qoustic Choice® Wound Therapy System, Model AR1000D Series AROBELLA MEDICAL, LLC NRB 2017-03-01 00853077002145 Qoustic Choice® Wound Therapy System Converter Hand Piece AROBELLA MEDICAL, LLC NRB 2017-03-01 00853077002152 Qoustic Wound Therapy System®, Qoustic Qurette® Probe, Type 11 AROBELLA MEDICAL, LLC NRB 2017-03-01 00853077002169 Qoustic Wound Therapy System®, Qoustic Qurette® Probe, Type 12 AROBELLA MEDICAL, LLC NRB 2017-03-01 00853077002176 Qoustic Wound Therapy System®, Qoustic Qurette® Probe, Type 13 AROBELLA MEDICAL, LLC NRB 2017-03-01 00853077002213 Qoustic Wound Therapy System®, Qoustic Qurette® Probe, Type 14 AROBELLA MEDICAL, LLC NRB 2017-03-01 00853077002220 Qoustic Wound Therapy System® Ultrasonic Generator AROBELLA MEDICAL, LLC NRB 2017-03-01 00853077002237 Qoustic Wound Therapy System® Ultrasonic Generator AROBELLA MEDICAL, LLC NRB 2017-03-01 00853077002244 Qoustic Choice® Wound Therapy System Ultrasonic Generator AROBELLA MEDICAL, LLC NRB 2017-03-01 00853077002183 Qoustic Choice® Wound Therapy System, Disposable Tubing Set AROBELLA MEDICAL, LLC NRB 2017-01-20 00816789010204 UltraMIST Treatment Wand ALLIQUA BIOMEDICAL, INC. NRB 2016-09-07 00816789010235 UltraMIST Applicator ALLIQUA BIOMEDICAL, INC. NRB 2016-09-07 00816789010242 MIST 360 Applicator ALLIQUA BIOMEDICAL, INC. NRB 2016-09-07 00816789010259 MIST Therapy Applicator ALLIQUA BIOMEDICAL, INC. NRB 2016-09-07 10816789010201 UltraMIST Treatment Wand ALLIQUA BIOMEDICAL, INC. NRB 2016-09-07 00816789010211 UltraMIST Generator ALLIQUA BIOMEDICAL, INC. NRB 2016-09-07
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