{"publicDeviceRecordKey":"05819d06-2f24-494b-b13c-f1e6824957cb","publicVersionStatus":"Update","deviceRecordStatus":"Published","publicVersionNumber":3,"publicVersionDate":"2024-09-11T00:00:00.000Z","devicePublishDate":"2020-09-24T00:00:00.000Z","deviceCommDistributionEndDate":null,"deviceCommDistributionStatus":"In Commercial Distribution","identifiers":{"identifier":[{"deviceId":"04046826146061","deviceIdType":"Primary","deviceIdIssuingAgency":"GS1","containsDINumber":null,"pkgQuantity":null,"pkgDiscontinueDate":null,"pkgStatus":null,"pkgType":null}]},"brandName":"Medicon","versionModelNumber":"75.95.34","catalogNumber":"75.95.34","dunsNumber":"315492330","companyName":"Medicon eG. Chirurgiemechaniker-Genossenschaft","deviceCount":1,"deviceDescription":"guide pin Ø 4.0mm ","DMExempt":false,"premarketExempt":true,"deviceHCTP":false,"deviceKit":false,"deviceCombinationProduct":false,"singleUse":false,"lotBatch":true,"serialNumber":false,"manufacturingDate":false,"expirationDate":false,"donationIdNumber":false,"labeledContainsNRL":false,"labeledNoNRL":false,"MRISafetyStatus":"Labeling does not contain MRI Safety Information","rx":true,"otc":false,"contacts":{"customerContact":[{"phone":"+490746220090","phoneExtension":null,"email":"sales@medicon.de"}]},"gmdnTerms":{"gmdn":[{"gmdnCode":"46165","gmdnPTName":"Orthopaedic guidewire, reusable","gmdnPTDefinition":"A thin, non-implantable rod designed to guide the insertion of a cannulated/tubular orthopaedic implant (typically an intramedullary nail, a bone screw or femoral fixation plate) and/or surgical instrument (e.g., drill bit) during an orthopaedic procedure. It is made of metal and is available in a variety of sizes, lengths, and designs (e.g., round-tip, trocar-tip, or flexible-tip). This is a reusable device.","implantable":false,"gmdnCodeStatus":"Active"}]},"productCodes":{"fdaProductCode":[{"productCode":"FZX","productCodeName":"Guide, surgical, instrument"}]},"deviceSizes":{"deviceSize":[]},"environmentalConditions":{"storageHandling":[]},"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,"premarketSubmissions":{"premarketSubmission":[]}}