<?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>8c93c130-0208-4a5f-a665-0466502f9dc0</publicDeviceRecordKey><publicVersionStatus>Update</publicVersionStatus><deviceRecordStatus>Published</deviceRecordStatus><publicVersionNumber>5</publicVersionNumber><publicVersionDate>2023-09-15</publicVersionDate><devicePublishDate>2015-09-20</devicePublishDate><deviceCommDistributionEndDate>2022-09-01</deviceCommDistributionEndDate><deviceCommDistributionStatus>Not in Commercial Distribution</deviceCommDistributionStatus><identifiers><identifier><deviceId>10886704040767</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>CODMAN HOLTER</brandName><versionModelNumber>82-1697</versionModelNumber><catalogNumber>821697</catalogNumber><dunsNumber>607846297</dunsNumber><companyName>Cerenovus, Inc.</companyName><deviceCount>1</deviceCount><deviceDescription>CODMAN HOLTER In-Line Shunt Filter, Hoffman Design</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 Conditional</MRISafetyStatus><rx>true</rx><otc>false</otc><contacts><customerContact><phone>+1(800)255-2500</phone><phoneExtension xsi:nil="true"/><email>xx@xx.xx</email></customerContact></contacts><premarketSubmissions><premarketSubmission><submissionNumber>K102961</submissionNumber><supplementNumber>000</supplementNumber></premarketSubmission></premarketSubmissions><gmdnTerms><gmdn><gmdnCode>15688</gmdnCode><gmdnPTName>Cerebrospinal fluid shunt filter</gmdnPTName><gmdnPTDefinition>A sterile implantable device intended to be used with a cerebrospinal fluid (CSF) shunt assembly (e.g., ventriculoperitoneal shunt, lumboperitoneal shunt) for in-line shunt placement to filter particles by size to prevent transmission of cells when draining CSF from the brain. It typically includes a cellulose membrane supported in a stainless steel mesh encased in, e.g., silicone, and has ports for connection to the shunt. It is used when neoplasms are present or suspected in patients who need treatment using a CSF shunt. It may be implanted behind the mastoid air cells to expose its content to radiation when applied.</gmdnPTDefinition><implantable>true</implantable><gmdnCodeStatus>Active</gmdnCodeStatus></gmdn></gmdnTerms><productCodes><fdaProductCode><productCode>JXG</productCode><productCodeName>Shunt, central nervous system and components</productCodeName></fdaProductCode></productCodes><deviceSizes/><environmentalConditions/><sterilization><deviceSterile>true</deviceSterile><sterilizationPriorToUse>false</sterilizationPriorToUse><methodTypes/></sterilization></device>