<?xml version='1.0' encoding='UTF-8'?><device xmlns='http://www.fda.gov/cdrh/gudid' xmlns:xsi='http://www.w3.org/2001/XMLSchema-instance'><publicDeviceRecordKey>3f97fa25-8c75-498e-aa68-9cd9d53768b1</publicDeviceRecordKey><publicVersionStatus>Update</publicVersionStatus><deviceRecordStatus>Published</deviceRecordStatus><publicVersionNumber>3</publicVersionNumber><publicVersionDate>2018-08-06</publicVersionDate><devicePublishDate>2017-03-01</devicePublishDate><deviceCommDistributionEndDate xsi:nil="true"/><deviceCommDistributionStatus>In Commercial Distribution</deviceCommDistributionStatus><identifiers><identifier><deviceId>00853077002145</deviceId><deviceIdType>Primary</deviceIdType><deviceIdIssuingAgency>GS1</deviceIdIssuingAgency><containsDINumber xsi:nil="true"/><pkgQuantity xsi:nil="true"/><pkgDiscontinueDate xsi:nil="true"/><pkgStatus xsi:nil="true"/><pkgType xsi:nil="true"/></identifier></identifiers><brandName>Qoustic Choice® Wound Therapy System Converter Hand Piece</brandName><versionModelNumber>AR1000D</versionModelNumber><catalogNumber>AR1000D-H/P</catalogNumber><dunsNumber>839978876</dunsNumber><companyName>AROBELLA MEDICAL, LLC</companyName><deviceCount>1</deviceCount><deviceDescription>Hand Piece, Converter, Qoustic Choice® Wound Therapy System, Model AR1000D Series</deviceDescription><DMExempt>false</DMExempt><premarketExempt>false</premarketExempt><deviceHCTP>false</deviceHCTP><deviceKit>false</deviceKit><deviceCombinationProduct>false</deviceCombinationProduct><singleUse>false</singleUse><lotBatch>false</lotBatch><serialNumber>true</serialNumber><manufacturingDate>true</manufacturingDate><expirationDate>false</expirationDate><donationIdNumber>false</donationIdNumber><labeledContainsNRL>false</labeledContainsNRL><labeledNoNRL>true</labeledNoNRL><MRISafetyStatus>Labeling does not contain MRI Safety Information</MRISafetyStatus><rx>true</rx><otc>false</otc><contacts><customerContact><phone>952-288-2810</phone><phoneExtension xsi:nil="true"/><email>lyoshikawa@arobella.com</email></customerContact><customerContact><phone>952-345-6840</phone><phoneExtension xsi:nil="true"/><email>service@arobella.com</email></customerContact></contacts><premarketSubmissions><premarketSubmission><submissionNumber>K062544</submissionNumber><supplementNumber>000</supplementNumber></premarketSubmission><premarketSubmission><submissionNumber>K131096</submissionNumber><supplementNumber>000</supplementNumber></premarketSubmission></premarketSubmissions><gmdnTerms><gmdn><gmdnCode>44750</gmdnCode><gmdnPTName>Soft-tissue ultrasonic surgical system handpiece, reusable</gmdnPTName><gmdnPTDefinition>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.</gmdnPTDefinition><implantable>false</implantable><gmdnCodeStatus>Active</gmdnCodeStatus></gmdn></gmdnTerms><productCodes><fdaProductCode><productCode>NRB</productCode><productCodeName>Wound Cleaner, Ultrasound</productCodeName></fdaProductCode><fdaProductCode><productCode>LFL</productCode><productCodeName>Instrument, Ultrasonic Surgical</productCodeName></fdaProductCode></productCodes><deviceSizes><deviceSize><sizeType>Weight</sizeType><size unit="Pound" value="1"/><sizeText xsi:nil="true"/></deviceSize><deviceSize><sizeType>Height</sizeType><size unit="Inch" value="6"/><sizeText xsi:nil="true"/></deviceSize><deviceSize><sizeType>Width</sizeType><size unit="Inch" value="12"/><sizeText xsi:nil="true"/></deviceSize><deviceSize><sizeType>Depth</sizeType><size unit="Inch" value="12"/><sizeText xsi:nil="true"/></deviceSize></deviceSizes><environmentalConditions><storageHandling><storageHandlingType>Storage Environment Temperature</storageHandlingType><storageHandlingHigh unit="Degrees Celsius" value="50"/><storageHandlingLow unit="Degrees Celsius" value="-20"/><storageHandlingSpecialConditionText xsi:nil="true"/></storageHandling><storageHandling><storageHandlingType>Storage Environment Humidity</storageHandlingType><storageHandlingHigh unit="Percent (%) Relative Humidity" value="90"/><storageHandlingLow unit="Percent (%) Relative Humidity" value="0"/><storageHandlingSpecialConditionText xsi:nil="true"/></storageHandling><storageHandling><storageHandlingType>Handling Environment Humidity</storageHandlingType><storageHandlingHigh unit="Percent (%) Relative Humidity" value="90"/><storageHandlingLow unit="Percent (%) Relative Humidity" value="0"/><storageHandlingSpecialConditionText xsi:nil="true"/></storageHandling></environmentalConditions><sterilization><deviceSterile>false</deviceSterile><sterilizationPriorToUse>true</sterilizationPriorToUse><methodTypes><sterilizationMethod>Liquid Chemical</sterilizationMethod><sterilizationMethod>Moist Heat or Steam Sterilization</sterilizationMethod></methodTypes></sterilization></device>