{"publicDeviceRecordKey":"91dd4a4c-7d76-4517-8a37-be8afb77dcb1","publicVersionStatus":"Update","deviceRecordStatus":"Published","publicVersionNumber":2,"publicVersionDate":"2024-05-22T00:00:00.000Z","devicePublishDate":"2021-07-30T00:00:00.000Z","deviceCommDistributionEndDate":null,"deviceCommDistributionStatus":"In Commercial Distribution","identifiers":{"identifier":[{"deviceId":"00873263008317","deviceIdType":"Primary","deviceIdIssuingAgency":"GS1","containsDINumber":null,"pkgQuantity":null,"pkgDiscontinueDate":null,"pkgStatus":null,"pkgType":null}]},"brandName":"STar™ Drive Frame Adapter","versionModelNumber":"FC8005-00831","catalogNumber":"FC8005","dunsNumber":"108179458","companyName":"FHC, INC.","deviceCount":1,"deviceDescription":"STar™ Drive Frame Adapter for use with Leibinger RM stereotactic frame","DMExempt":false,"premarketExempt":false,"deviceHCTP":false,"deviceKit":false,"deviceCombinationProduct":false,"singleUse":false,"lotBatch":false,"serialNumber":true,"manufacturingDate":true,"expirationDate":false,"donationIdNumber":false,"labeledContainsNRL":false,"labeledNoNRL":false,"MRISafetyStatus":"MR Unsafe","rx":true,"otc":false,"contacts":{"customerContact":[{"phone":"+1(800)326-2905","phoneExtension":null,"email":"fhcinc@fh-co.com"}]},"premarketSubmissions":{"premarketSubmission":[{"submissionNumber":"K092562","supplementNumber":"000"}]},"gmdnTerms":{"gmdn":[{"gmdnCode":"46863","gmdnPTName":"Neurosurgical micro targeting drive","gmdnPTDefinition":"A calibrated guide mechanism used by a surgeon to manually operate a Z-axis positioner which allows extremely accurate placement of a single or multiple microelectrodes, stimulation electrodes, probes, instruments, or implantable devices, along a chosen track during neurosurgery on the brain. It is intended to be used with a neurosurgical stereotactic system. It typically consists of a metal, graduated frame along which an instrument holder traverses (e.g., approximately 50 mm) by adjustment of a graduated knob that revolves a fine pitched lead screw (e.g., one revolution of the knob will advance the drive by 1 mm). Some types can have an electrical motor attached for motorized drive.","implantable":false,"gmdnCodeStatus":"Active"}]},"productCodes":{"fdaProductCode":[{"productCode":"HAW","productCodeName":"Neurological stereotaxic Instrument"}]},"deviceSizes":{"deviceSize":[]},"environmentalConditions":{"storageHandling":[{"storageHandlingType":"Storage Environment Temperature","storageHandlingHigh":{"unit":"Degrees Celsius","value":"57"},"storageHandlingLow":{"unit":"","value":""},"storageHandlingSpecialConditionText":null}]},"sterilization":{"deviceSterile":false,"sterilizationPriorToUse":true,"methodTypes":{"sterilizationMethod":["Moist Heat or Steam Sterilization"]}},"xmlns":"http://www.fda.gov/cdrh/gudid","xsi":"http://www.w3.org/2001/XMLSchema-instance","anomaly":null}