<?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>b568aaf2-ba1c-4947-aac6-896e9c34a3b6</publicDeviceRecordKey><publicVersionStatus>Update</publicVersionStatus><deviceRecordStatus>Published</deviceRecordStatus><publicVersionNumber>2</publicVersionNumber><publicVersionDate>2018-03-29</publicVersionDate><devicePublishDate>2017-01-24</devicePublishDate><deviceCommDistributionEndDate xsi:nil="true"/><deviceCommDistributionStatus>In Commercial Distribution</deviceCommDistributionStatus><identifiers><identifier><deviceId>D0470011751</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>GC PLASTIC SYRINGE</brandName><versionModelNumber>001175</versionModelNumber><catalogNumber>001175</catalogNumber><dunsNumber>005473608</dunsNumber><companyName>Gc America Inc.</companyName><deviceCount>1</deviceCount><deviceDescription>GC Plastic Syringe Kit, Packed with 2 syringes, extra &quot;O&quot; Rings, Tips and Cleaning Brush</deviceDescription><DMExempt>false</DMExempt><premarketExempt>true</premarketExempt><deviceHCTP>false</deviceHCTP><deviceKit>false</deviceKit><deviceCombinationProduct>false</deviceCombinationProduct><singleUse>false</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>+1(708)597-0900</phone><phoneExtension xsi:nil="true"/><email>customerservice@gcamerica.com</email></customerContact></contacts><gmdnTerms><gmdn><gmdnCode>35860</gmdnCode><gmdnPTName>Dental impression material syringe, reusable</gmdnPTName><gmdnPTDefinition>A non-sterile hand-held manual dental instrument designed to inject impression material into an impression tray or directly into a patient&apos;s mouth. This is a reusable device.</gmdnPTDefinition><implantable>false</implantable><gmdnCodeStatus>Active</gmdnCodeStatus></gmdn></gmdnTerms><productCodes><fdaProductCode><productCode>EID</productCode><productCodeName>SYRINGE, RESTORATIVE AND IMPRESSION MATERIAL</productCodeName></fdaProductCode></productCodes><deviceSizes/><environmentalConditions/><sterilization><deviceSterile>false</deviceSterile><sterilizationPriorToUse>false</sterilizationPriorToUse><methodTypes/></sterilization></device>