{"publicDeviceRecordKey":"8c93c130-0208-4a5f-a665-0466502f9dc0","publicVersionStatus":"Update","deviceRecordStatus":"Published","publicVersionNumber":5,"publicVersionDate":"2023-09-15T00:00:00.000Z","devicePublishDate":"2015-09-20T00:00:00.000Z","deviceCommDistributionEndDate":"2022-09-01T00:00:00.000Z","deviceCommDistributionStatus":"Not in Commercial Distribution","identifiers":{"identifier":[{"deviceId":"10886704040767","deviceIdType":"Primary","deviceIdIssuingAgency":"GS1","containsDINumber":null,"pkgQuantity":null,"pkgDiscontinueDate":null,"pkgStatus":null,"pkgType":null}]},"brandName":"CODMAN HOLTER","versionModelNumber":"82-1697","catalogNumber":"821697","dunsNumber":"607846297","companyName":"Cerenovus, Inc.","deviceCount":1,"deviceDescription":"CODMAN HOLTER In-Line Shunt Filter, Hoffman Design","DMExempt":false,"premarketExempt":false,"deviceHCTP":false,"deviceKit":false,"deviceCombinationProduct":false,"singleUse":true,"lotBatch":true,"serialNumber":false,"manufacturingDate":false,"expirationDate":true,"donationIdNumber":false,"labeledContainsNRL":false,"labeledNoNRL":false,"MRISafetyStatus":"MR Conditional","rx":true,"otc":false,"contacts":{"customerContact":[{"phone":"+1(800)255-2500","phoneExtension":null,"email":"xx@xx.xx"}]},"premarketSubmissions":{"premarketSubmission":[{"submissionNumber":"K102961","supplementNumber":"000"}]},"gmdnTerms":{"gmdn":[{"gmdnCode":"15688","gmdnPTName":"Cerebrospinal fluid shunt filter","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.","implantable":true,"gmdnCodeStatus":"Active"}]},"productCodes":{"fdaProductCode":[{"productCode":"JXG","productCodeName":"Shunt, central nervous system and components"}]},"deviceSizes":{"deviceSize":[]},"environmentalConditions":{"storageHandling":[]},"sterilization":{"deviceSterile":true,"sterilizationPriorToUse":false,"methodTypes":{"sterilizationMethod":[]}},"xmlns":"http://www.fda.gov/cdrh/gudid","xsi":"http://www.w3.org/2001/XMLSchema-instance","anomaly":null}