{"publicDeviceRecordKey":"623e8d40-a978-40e2-8f96-6ca999823138","publicVersionStatus":"New","deviceRecordStatus":"Published","publicVersionNumber":1,"publicVersionDate":"2020-10-02T00:00:00.000Z","devicePublishDate":"2020-09-24T00:00:00.000Z","deviceCommDistributionEndDate":null,"deviceCommDistributionStatus":"In Commercial Distribution","identifiers":{"identifier":[{"deviceId":"04046826015282","deviceIdType":"Primary","deviceIdIssuingAgency":"GS1","containsDINumber":null,"pkgQuantity":null,"pkgDiscontinueDate":null,"pkgStatus":null,"pkgType":null}]},"brandName":"Medicon","versionModelNumber":"09.96.08","catalogNumber":"09.96.08","dunsNumber":"315492330","companyName":"Medicon eG. Chirurgiemechaniker-Genossenschaft","deviceCount":1,"deviceDescription":"endarterectomy stripper Ø 8.5mm 55cm","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":"31729","gmdnPTName":"Intraluminal artery stripper, reusable","gmdnPTDefinition":"A hand-held manual surgical instrument designed to perform an endarterectomy (the removal of plaque deposits from arteriosclerotic arteries) during a vasculature reconstruction procedure. It is typically made of high-grade stainless steel and is available in various designs including the \"MollRing cutter\". Indications for its use include disabling claudication, ischemic pain at rest, ischemic skin lesions, or gangrene. This is a reusable device.","implantable":false,"gmdnCodeStatus":"Active"}]},"productCodes":{"fdaProductCode":[{"productCode":"GDI","productCodeName":"DISSECTOR, SURGICAL, GENERAL \u0026 PLASTIC SURGERY"}]},"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":[]}}