<?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>b3f56998-914c-49e5-924a-189f87ef54c2</publicDeviceRecordKey><publicVersionStatus>Update</publicVersionStatus><deviceRecordStatus>Published</deviceRecordStatus><publicVersionNumber>3</publicVersionNumber><publicVersionDate>2018-07-06</publicVersionDate><devicePublishDate>2016-09-17</devicePublishDate><deviceCommDistributionEndDate xsi:nil="true"/><deviceCommDistributionStatus>In Commercial Distribution</deviceCommDistributionStatus><identifiers><identifier><deviceId>10873263003289</deviceId><deviceIdType>Package</deviceIdType><deviceIdIssuingAgency>GS1</deviceIdIssuingAgency><containsDINumber>00873263003282</containsDINumber><pkgQuantity>5</pkgQuantity><pkgDiscontinueDate xsi:nil="true"/><pkgStatus>In Commercial Distribution</pkgStatus><pkgType>PK/5</pkgType></identifier><identifier><deviceId>00873263003282</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>microTargeting™ Insertion Tube</brandName><versionModelNumber>66-IT-DB11P-00328</versionModelNumber><catalogNumber>66-IT-DB11P</catalogNumber><dunsNumber>108179458</dunsNumber><companyName>FHC, INC.</companyName><deviceCount>1</deviceCount><deviceDescription>microTargeting Single Insertion Tube with Stylet, 10mm above target, 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>MR Unsafe</MRISafetyStatus><rx>true</rx><otc>false</otc><contacts><customerContact><phone>+1(800)326-2905</phone><phoneExtension xsi:nil="true"/><email>fhcinc@fh-co.com</email></customerContact></contacts><premarketSubmissions><premarketSubmission><submissionNumber>K011775</submissionNumber><supplementNumber>000</supplementNumber></premarketSubmission></premarketSubmissions><gmdnTerms><gmdn><gmdnCode>61964</gmdnCode><gmdnPTName>Intracerebral cannula, implantable</gmdnPTName><gmdnPTDefinition>A sterile, implantable tube intended to be surgically placed in a specific area of the brain (e.g., basal ganglia) to position a deep brain electrical stimulation lead/electrode, using a stereotactic surgery system, and to function as a guide for subsequent and regular placement and/or removal of the lead/electrode. It is made of synthetic polymer materials (e.g., polyurethane) and may include a stylet/trocar blade.</gmdnPTDefinition><implantable>true</implantable><gmdnCodeStatus>Active</gmdnCodeStatus></gmdn></gmdnTerms><productCodes><fdaProductCode><productCode>HAW</productCode><productCodeName>Neurological stereotaxic Instrument</productCodeName></fdaProductCode></productCodes><deviceSizes><deviceSize><sizeType>Length</sizeType><size unit="Millimeter" value="223.6"/><sizeText xsi:nil="true"/></deviceSize><deviceSize><sizeType>Lumen/Inner Diameter</sizeType><size unit="Millimeter" value="1.6"/><sizeText xsi:nil="true"/></deviceSize><deviceSize><sizeType>Outer Diameter</sizeType><size unit="Millimeter" value="1.83"/><sizeText xsi:nil="true"/></deviceSize></deviceSizes><environmentalConditions><storageHandling><storageHandlingType>Handling Environment Humidity</storageHandlingType><storageHandlingHigh unit="Percent (%) Relative Humidity" value="95"/><storageHandlingLow unit="Percent (%) Relative Humidity" value="0"/><storageHandlingSpecialConditionText xsi:nil="true"/></storageHandling><storageHandling><storageHandlingType>Storage Environment Temperature</storageHandlingType><storageHandlingHigh unit="Degrees Celsius" value="40"/><storageHandlingLow unit="Degrees Celsius" value="0"/><storageHandlingSpecialConditionText xsi:nil="true"/></storageHandling><storageHandling><storageHandlingType>Storage Environment Humidity</storageHandlingType><storageHandlingHigh unit="Percent (%) Relative Humidity" value="95"/><storageHandlingLow unit="Percent (%) Relative Humidity" value="0"/><storageHandlingSpecialConditionText xsi:nil="true"/></storageHandling></environmentalConditions><sterilization><deviceSterile>true</deviceSterile><sterilizationPriorToUse>true</sterilizationPriorToUse><methodTypes><sterilizationMethod>Moist Heat or Steam Sterilization</sterilizationMethod><sterilizationMethod>Ethylene Oxide</sterilizationMethod></methodTypes></sterilization></device>