<?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>ca97eab7-d483-47dd-8ed8-bffe3cc6f732</publicDeviceRecordKey><publicVersionStatus>Update</publicVersionStatus><deviceRecordStatus>Published</deviceRecordStatus><publicVersionNumber>2</publicVersionNumber><publicVersionDate>2020-07-07</publicVersionDate><devicePublishDate>2019-12-18</devicePublishDate><deviceCommDistributionEndDate xsi:nil="true"/><deviceCommDistributionStatus>In Commercial Distribution</deviceCommDistributionStatus><identifiers><identifier><deviceId>B360PSVGS0</deviceId><deviceIdType>Primary</deviceIdType><deviceIdIssuingAgency>HIBCC</deviceIdIssuingAgency><containsDINumber xsi:nil="true"/><pkgQuantity xsi:nil="true"/><pkgDiscontinueDate xsi:nil="true"/><pkgStatus xsi:nil="true"/><pkgType xsi:nil="true"/></identifier></identifiers><brandName>PRAGER SHELL® P106SVGS</brandName><versionModelNumber>P106SV GOLD SERIES</versionModelNumber><catalogNumber xsi:nil="true"/><dunsNumber>829391734</dunsNumber><companyName>ESI CORPORATION</companyName><deviceCount>1</deviceCount><deviceDescription>PRAGER SHELL® P106 AUTOCLAVABLE ULTRASOUND IMMERSION SHELL.</deviceDescription><DMExempt>false</DMExempt><premarketExempt>false</premarketExempt><deviceHCTP>false</deviceHCTP><deviceKit>false</deviceKit><deviceCombinationProduct>false</deviceCombinationProduct><singleUse>false</singleUse><lotBatch>false</lotBatch><serialNumber>false</serialNumber><manufacturingDate>true</manufacturingDate><expirationDate>false</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>763-473-2533</phone><phoneExtension xsi:nil="true"/><email>sales@eyesurgin.com</email></customerContact></contacts><premarketSubmissions><premarketSubmission><submissionNumber>K082893</submissionNumber><supplementNumber>000</supplementNumber></premarketSubmission></premarketSubmissions><gmdnTerms><gmdn><gmdnCode>11653</gmdnCode><gmdnPTName>Eye wash cup</gmdnPTName><gmdnPTDefinition>A receptacle designed to fit around the eye socket and which is filled with warm water or an eyewash solution and placed over the eye to allow the liquid to wash the affected eye. It is typically used as a first line measure when dust or other particles have inadvertently entered the eye. It is usually made of plastic, glass or a ceramic material and is intended for use in the home, in a clinical setting, or for hospitalized or institutionalized patients. This is a reusable device.</gmdnPTDefinition><implantable>false</implantable><gmdnCodeStatus>Active</gmdnCodeStatus></gmdn></gmdnTerms><productCodes><fdaProductCode><productCode>ITX</productCode><productCodeName>Transducer, Ultrasonic, Diagnostic</productCodeName></fdaProductCode></productCodes><deviceSizes><deviceSize><sizeType>Lumen/Inner Diameter</sizeType><size unit="Millimeter" value="12.2"/><sizeText xsi:nil="true"/></deviceSize><deviceSize><sizeType>Outer Diameter</sizeType><size unit="Millimeter" value="14"/><sizeText xsi:nil="true"/></deviceSize></deviceSizes><environmentalConditions/><sterilization><deviceSterile>false</deviceSterile><sterilizationPriorToUse>true</sterilizationPriorToUse><methodTypes><sterilizationMethod>Moist Heat or Steam Sterilization</sterilizationMethod></methodTypes></sterilization></device>