Qoustic Wound Therapy System®, Qoustic Qurette® Probe, Type 14 AR1000D-QT14

GUDID 00853077002213

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

AROBELLA MEDICAL, LLC

Soft-tissue ultrasonic surgical system
Primary Device ID00853077002213
NIH Device Record Keyb1ff6c67-d30e-49fa-9ca2-fdae95b14fbe
Commercial Distribution StatusIn Commercial Distribution
Brand NameQoustic Wound Therapy System®, Qoustic Qurette® Probe, Type 14
Version Model NumberAR1000D
Catalog NumberAR1000D-QT14
Company DUNS839978876
Company NameAROBELLA MEDICAL, LLC
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usefalse
Lot Batchtrue
Serial Numberfalse
Manufacturing Datefalse
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latextrue
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone952-288-2810
Emaillyoshikawa@arobella.com

Device Dimensions

Outer Diameter10 Millimeter
Outer Diameter10 Millimeter
Outer Diameter10 Millimeter
Outer Diameter10 Millimeter
Outer Diameter10 Millimeter
Outer Diameter10 Millimeter

Operating and Storage Conditions

Handling Environment HumidityBetween 0 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Handling Environment HumidityBetween 0 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Handling Environment HumidityBetween 0 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity

Device Identifiers

Device Issuing AgencyDevice ID
GS100853077002213 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

NRBWound Cleaner, Ultrasound

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[00853077002213]

Moist Heat or Steam Sterilization

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number3
Public Version Date2018-08-06
Device Publish Date2017-03-01

Devices Manufactured by AROBELLA MEDICAL, LLC

00853077002220 - Qoustic Wound Therapy System® Ultrasonic Generator2018-09-24 Ultrasonic Generator, Qoustic Wound Therapy System®, Model AR1000 Series
00853077002237 - Qoustic Wound Therapy System® Ultrasonic Generator2018-09-24 Ultrasonic Generator, Qoustic Wound Therapy System®, Model AR1000B Series
00853077002244 - Qoustic Choice® Wound Therapy System Ultrasonic Generator2018-09-24 Ultrasonic Generator, Qoustic Choice® Wound Therapy System, Model AR1000D Series
00853077002008 - Qoustic Wound Therapy System®, Model AR1000 Series2018-08-06 Qoustic Wound Therapy System®, Model AR1000 Series - ultrasound wound therapy system for wound debridement and management
00853077002015 - Qoustic Wound Therapy System® Converter Hand Piece2018-08-06 Hand Piece, Converter, Qoustic Wound Therapy System®, Model AR1000 Series
00853077002022 - Qoustic Wound Therapy System®, Cart, AR Series, Type 1, Support2018-08-06 Support, Cart, AR Series, Type 1, Qoustic Wound Therapy System®, Model AR1000 Series
00853077002039 - Qoustic Wound Therapy System®, Cart, AR Series, Type 1, Base2018-08-06 Base, Cart, AR Series, Type 1, Qoustic Wound Therapy System®, Model AR1000 Series
00853077002060 - Qoustic Wound Therapy System®, Qoustic Qurette® Probe, Type 12018-08-06 Qoustic Wound Therapy System®, Qoustic Qurette® Probe, Type 1 + Qoustic Qurette® Shroud, Type P

Trademark Results [Qoustic Wound Therapy System]

Mark Image

Registration | Serial
Company
Trademark
Application Date
QOUSTIC WOUND THERAPY SYSTEM
QOUSTIC WOUND THERAPY SYSTEM
77172279 3481679 Dead/Cancelled
Arobella Medical, LLC
2007-05-03
© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.