<?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>b317ece8-0a2a-4a40-820d-3ea38f5ea091</publicDeviceRecordKey><publicVersionStatus>Update</publicVersionStatus><deviceRecordStatus>Published</deviceRecordStatus><publicVersionNumber>3</publicVersionNumber><publicVersionDate>2018-07-06</publicVersionDate><devicePublishDate>2015-09-18</devicePublishDate><deviceCommDistributionEndDate xsi:nil="true"/><deviceCommDistributionStatus>In Commercial Distribution</deviceCommDistributionStatus><identifiers><identifier><deviceId>00841365106934</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>Best Medical International</brandName><versionModelNumber>1830</versionModelNumber><catalogNumber xsi:nil="true"/><dunsNumber>086352655</dunsNumber><companyName>BEST MEDICAL INTERNATIONAL, INC.</companyName><deviceCount>1</deviceCount><deviceDescription xsi:nil="true"/><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>true</manufacturingDate><expirationDate>true</expirationDate><donationIdNumber>false</donationIdNumber><labeledContainsNRL>false</labeledContainsNRL><labeledNoNRL>false</labeledNoNRL><MRISafetyStatus>Labeling does not contain MRI Safety Information</MRISafetyStatus><rx>false</rx><otc>false</otc><contacts/><premarketSubmissions><premarketSubmission><submissionNumber>K910862</submissionNumber><supplementNumber>000</supplementNumber></premarketSubmission></premarketSubmissions><gmdnTerms><gmdn><gmdnCode>38427</gmdnCode><gmdnPTName>Prostate brachytherapy system applicator, remote-afterloading</gmdnPTName><gmdnPTDefinition>A remote afterloading brachytherapy applicator specifically designed for use in radiation therapy treatments of the prostate. It is designed for temporary implantation within the prostate and serve as a guide for computer-controlled placement and removal of single or multiple radioactive sources. This GMDN code includes a variety of applicators, e.g., hollow needles, tubes, or catheters, and their associated components.</gmdnPTDefinition><implantable>false</implantable><gmdnCodeStatus>Active</gmdnCodeStatus></gmdn></gmdnTerms><productCodes><fdaProductCode><productCode>IWJ</productCode><productCodeName>System, Applicator, Radionuclide, Manual</productCodeName></fdaProductCode></productCodes><deviceSizes/><environmentalConditions/><sterilization><deviceSterile>true</deviceSterile><sterilizationPriorToUse>false</sterilizationPriorToUse><methodTypes/></sterilization></device>