{"publicDeviceRecordKey":"5794f46b-af7d-452d-9b07-bf5857fa9224","publicVersionStatus":"Update","deviceRecordStatus":"Published","publicVersionNumber":4,"publicVersionDate":"2024-03-13T00:00:00.000Z","devicePublishDate":"2015-06-10T00:00:00.000Z","deviceCommDistributionEndDate":null,"deviceCommDistributionStatus":"In Commercial Distribution","identifiers":{"identifier":[{"deviceId":"04057217001050","deviceIdType":"Primary","deviceIdIssuingAgency":"GS1","containsDINumber":null,"pkgQuantity":null,"pkgDiscontinueDate":null,"pkgStatus":null,"pkgType":null}]},"brandName":"NA","versionModelNumber":"A06081S","catalogNumber":null,"dunsNumber":"332068761","companyName":"Z-Medical GmbH  +  Co.  KG","deviceCount":1,"deviceDescription":null,"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":"Labeling does not contain MRI Safety Information","rx":true,"otc":false,"contacts":{"customerContact":[{"phone":"+497462945540","phoneExtension":null,"email":"info@z-medical.de"}]},"gmdnTerms":{"gmdn":[{"gmdnCode":"65866","gmdnPTName":"Pedicle screw guide","gmdnPTDefinition":"A thin metal rod intended to guide the implantation of a pedicle screw during a minimally-invasive procedure, where it can also function as a guide for a gauge to provide a screw length measurement. It is inserted into the pedicle of a vertebra so that a cannulated pedicle screw is advanced over the guide, after a gauge is used over the guide to provide a measurement. This is a single-use device.","implantable":false,"gmdnCodeStatus":"Active"}]},"productCodes":{"fdaProductCode":[{"productCode":"HTY","productCodeName":"Pin, Fixation, Smooth"}]},"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,"premarketSubmissions":{"premarketSubmission":[]}}