<?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>d5a4c0ec-0029-402c-8630-3473f4627f2f</publicDeviceRecordKey><publicVersionStatus>Update</publicVersionStatus><deviceRecordStatus>Published</deviceRecordStatus><publicVersionNumber>3</publicVersionNumber><publicVersionDate>2018-07-06</publicVersionDate><devicePublishDate>2016-09-01</devicePublishDate><deviceCommDistributionEndDate>2017-06-30</deviceCommDistributionEndDate><deviceCommDistributionStatus>Not in Commercial Distribution</deviceCommDistributionStatus><identifiers><identifier><deviceId>07613353000332</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><identifier><deviceId>07613353000349</deviceId><deviceIdType>Package</deviceIdType><deviceIdIssuingAgency>GS1</deviceIdIssuingAgency><containsDINumber>07613353000332</containsDINumber><pkgQuantity>5</pkgQuantity><pkgDiscontinueDate>2017-06-30</pkgDiscontinueDate><pkgStatus>Not in Commercial Distribution</pkgStatus><pkgType xsi:nil="true"/></identifier></identifiers><brandName>LithoClast</brandName><versionModelNumber>DT-059</versionModelNumber><catalogNumber>M0068407500</catalogNumber><dunsNumber>481233849</dunsNumber><companyName>E.M.S. Electro Medical Systems S.A.</companyName><deviceCount>1</deviceCount><deviceDescription>Stone catcher - sterile </deviceDescription><DMExempt>false</DMExempt><premarketExempt>false</premarketExempt><deviceHCTP>false</deviceHCTP><deviceKit>false</deviceKit><deviceCombinationProduct>false</deviceCombinationProduct><singleUse>true</singleUse><lotBatch>true</lotBatch><serialNumber>false</serialNumber><manufacturingDate>false</manufacturingDate><expirationDate>true</expirationDate><donationIdNumber>false</donationIdNumber><labeledContainsNRL>false</labeledContainsNRL><labeledNoNRL>false</labeledNoNRL><MRISafetyStatus>Labeling does not contain MRI Safety Information</MRISafetyStatus><rx>true</rx><otc>false</otc><contacts><customerContact><phone>+41229944700</phone><phoneExtension xsi:nil="true"/><email>udi@ems-ch.com</email></customerContact></contacts><premarketSubmissions><premarketSubmission><submissionNumber>K963285</submissionNumber><supplementNumber>000</supplementNumber></premarketSubmission></premarketSubmissions><gmdnTerms><gmdn><gmdnCode>47464</gmdnCode><gmdnPTName>Intracorporeal lithotripsy suction system</gmdnPTName><gmdnPTDefinition>An assembly of devices designed for use with an intracorporeal lithotripsy system to evacuate, by suction, the irrigation fluid-containing fragments of urinary calculi from the kidneys, ureters, and bladder during lithotripsy. It typically consists of a pneumatically-powered pump that creates suction via the venturi mechanism, a vacuum gauge, vacuum control knob, a compressed air connector, tubing, a moisture filter, and possibly a microbial filter. The vacuum created by the pump is applied to the body through the tubing and an inserted probe, for the removal of the calculi in a stone catcher and the fluid in a collection container.</gmdnPTDefinition><implantable>false</implantable><gmdnCodeStatus>Active</gmdnCodeStatus></gmdn></gmdnTerms><productCodes><fdaProductCode><productCode>FFK</productCode><productCodeName>Lithotriptor, Electro-Hydraulic</productCodeName></fdaProductCode></productCodes><deviceSizes/><environmentalConditions/><sterilization><deviceSterile>true</deviceSterile><sterilizationPriorToUse>false</sterilizationPriorToUse><methodTypes/></sterilization></device>