AROBELLA MEDICAL, LLC

Address:111 Cheshire Lane, Suite 700,Minnetonka,MN,55305,US

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Device Class

Class-1 (A medical device with low to moderate risk that requires general controls) Class-2 (A medical device with a moderate to high risk that requires special controls) Class-3 (A medical device with high risk that requires premarket approval) Class-U (Unclassified)

Product Code

Instrument, Ultrasonic Surgical (LFL) (10) Wound Cleaner, Ultrasound (NRB) (10)

Premarket Exempt

Clear

Qoustic Choice® Wound Therapy System, Model AR1000D Series - 00853077002138 Catalog Number : AR1000D-SYS

Device Description : Qoustic Choice® Wound Therapy System, Model AR1000D Series - ultrasound wound th Qoustic Choice® Wound Therapy System, Model AR1000D Series - ultrasound wound therapy system for wound debridement and management

Device Class : 2

Duns Number: 839978876

Premarket Exempt : No

Product Code : NRB, LFL

Prescription Use : Yes

Device Count : 1

Qoustic Choice® Wound Therapy System Converter Hand Piece - 00853077002145 Catalog Number : AR1000D-H/P

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

Device Class : 2

Duns Number: 839978876

Premarket Exempt : No

Product Code : NRB, LFL

Prescription Use : Yes

Device Count : 1

Qoustic Wound Therapy System®, Qoustic Qurette® Probe, Type 11 - 00853077002152 Catalog Number : AR1000D-QT11

Device Description : Qoustic Wound Therapy System®, Qoustic Qurette® Probe, Type 11 + Shroud, Type PWD

Device Class : 2

Duns Number: 839978876

Premarket Exempt : No

Product Code : NRB, LFL

Prescription Use : Yes

Device Count : 1

Qoustic Wound Therapy System®, Qoustic Qurette® Probe, Type 12 - 00853077002169 Catalog Number : AR1000D-QT12

Device Description : Qoustic Wound Therapy System®, Qoustic Qurette® Probe, Type 12 + Qoustic Qurette Qoustic Wound Therapy System®, Qoustic Qurette® Probe, Type 12 + Qoustic Qurette® Shroud, Type PWD

Device Class : 2

Duns Number: 839978876

Premarket Exempt : No

Product Code : NRB, LFL

Prescription Use : Yes

Device Count : 1

Qoustic Wound Therapy System®, Qoustic Qurette® Probe, Type 13 - 00853077002176 Catalog Number : AR1000D-QT13

Device Description : Qoustic Wound Therapy System®, Qoustic Qurette® Probe, Type 13 + Qoustic Qurette Qoustic Wound Therapy System®, Qoustic Qurette® Probe, Type 13 + Qoustic Qurette® Shroud, Type PWD

Device Class : 2

Duns Number: 839978876

Premarket Exempt : No

Product Code : NRB, LFL

Prescription Use : Yes

Device Count : 1

Qoustic Choice® Wound Therapy System, Disposable Tubing Set - 00853077002183 Catalog Number : AR1000D-DTS

Device Description : Disposable Tubing Set, Qoustic Choice® Wound Therapy System, Model AR1000D Series

Device Class : 2

Duns Number: 839978876

Premarket Exempt : No

Product Code : NRB, LFL

Prescription Use : Yes

Device Count : 1

Qoustic Wound Therapy System®, Qoustic Qurette® Probe, Type 14 - 00853077002213 Catalog Number : AR1000D-QT14

Device Description : Qoustic Wound Therapy System®, Qoustic Qurette® Probe, Type 14 + Qoustic Qurette Qoustic Wound Therapy System®, Qoustic Qurette® Probe, Type 14 + Qoustic Qurette® Shroud, Type P

Device Class : 2

Duns Number: 839978876

Premarket Exempt : No

Product Code : NRB, LFL

Prescription Use : Yes

Device Count : 1

Qoustic Wound Therapy System® Ultrasonic Generator - 00853077002220 Catalog Number : AR1000-GEN

Device Description : Ultrasonic Generator, Qoustic Wound Therapy System®, Model AR1000 Series

Device Class : 2

Duns Number: 839978876

Premarket Exempt : No

Product Code : NRB, LFL

Prescription Use : Yes

Device Count : 1

Qoustic Wound Therapy System® Ultrasonic Generator - 00853077002237 Catalog Number : AR1000B-GEN

Device Description : Ultrasonic Generator, Qoustic Wound Therapy System®, Model AR1000B Series

Device Class : 2

Duns Number: 839978876

Premarket Exempt : No

Product Code : NRB, LFL

Prescription Use : Yes

Device Count : 1

Qoustic Choice® Wound Therapy System Ultrasonic Generator - 00853077002244 Catalog Number : AR1000D-GEN

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

Device Class : 2

Duns Number: 839978876

Premarket Exempt : No

Product Code : NRB, LFL

Prescription Use : Yes

Device Count : 1

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