AROBELLA MEDICAL, LLC

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

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Filters

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 Wound Therapy System®, Model AR1000 Series - 00853077002008 Catalog Number : AR1000-SYS

Device Description : Qoustic Wound Therapy System®, Model AR1000 Series - ultrasound wound therapy sy Qoustic Wound Therapy System®, Model AR1000 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 Wound Therapy System® Converter Hand Piece - 00853077002015 Catalog Number : AR1000-H/P

Device Description : Hand Piece, Converter, 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®, Cart, AR Series, Type 1, Support - 00853077002022 Catalog Number : AR1000-CRT1A

Device Description : Support, Cart, AR Series, Type 1, 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®, Cart, AR Series, Type 1, Base - 00853077002039 Catalog Number : AR1000-CRT1B

Device Description : Base, Cart, AR Series, Type 1, 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®, Qoustic Qurette® Probe, Type 1 - 00853077002060 Catalog Number : AR1000-QT1

Device Description : Qoustic Wound Therapy System®, Qoustic Qurette® Probe, Type 1 + Qoustic Qurette® Qoustic Wound Therapy System®, Qoustic Qurette® Probe, Type 1 + 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®, Model AR1000B Series - 00853077002077 Catalog Number : AR1000B-SYS

Device Description : Qoustic Wound Therapy System®, Model AR1000B Series - ultrasound wound therapy s Qoustic Wound Therapy System®, Model AR1000B 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 Wound Therapy System®, Qoustic Qurette® Probe, Type 4 - 00853077002091 Catalog Number : AR1000-QT4

Device Description : Qoustic Wound Therapy System®, Qoustic Qurette® Probe, Type 4 + Qoustic Qurette® Qoustic Wound Therapy System®, Qoustic Qurette® Probe, Type 4 + 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®, Qoustic Qurette® Probe, Type 6 - 00853077002107 Catalog Number : AR1000-QT6

Device Description : Qoustic Wound Therapy System®, Qoustic Qurette® Probe, Type 6 + Qoustic Qurette® Qoustic Wound Therapy System®, Qoustic Qurette® Probe, Type 6 + 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®, Qoustic Qurette® Probe, Type 7 - 00853077002114 Catalog Number : AR1000-QT7

Device Description : Qoustic Wound Therapy System®, Qoustic Qurette® Probe, Type 7 + Qoustic Qurette® Qoustic Wound Therapy System®, Qoustic Qurette® Probe, Type 7 + 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® Qoustic Key® - 00853077002121 Catalog Number : AR1000-KEY

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

Device Class : 2

Duns Number: 839978876

Premarket Exempt : No

Product Code : NRB, LFL

Prescription Use : Yes

Device Count : 1

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