{"publicDeviceRecordKey":"0bf7bd54-4cc7-42f0-82a3-915c71e26c5e","publicVersionStatus":"Update","deviceRecordStatus":"Published","publicVersionNumber":3,"publicVersionDate":"2026-06-08T00:00:00.000Z","devicePublishDate":"2019-10-02T00:00:00.000Z","deviceCommDistributionEndDate":null,"deviceCommDistributionStatus":"In Commercial Distribution","identifiers":{"identifier":[{"deviceId":"18055002906576","deviceIdType":"Package","deviceIdIssuingAgency":"GS1","containsDINumber":"08055002906579","pkgQuantity":20,"pkgDiscontinueDate":null,"pkgStatus":"In Commercial Distribution","pkgType":null},{"deviceId":"08055002906579","deviceIdType":"Primary","deviceIdIssuingAgency":"GS1","containsDINumber":null,"pkgQuantity":null,"pkgDiscontinueDate":null,"pkgStatus":null,"pkgType":null}]},"brandName":"FRANSEEN","versionModelNumber":"FR20160-01","catalogNumber":null,"dunsNumber":"440211428","companyName":"MEDAX SRL UNIPERSONALE","deviceCount":1,"deviceDescription":"FRANSEEN fine aspiration needle 20G x 160MM","DMExempt":false,"premarketExempt":false,"deviceHCTP":false,"deviceKit":false,"deviceCombinationProduct":false,"singleUse":true,"lotBatch":true,"serialNumber":false,"manufacturingDate":true,"expirationDate":true,"donationIdNumber":false,"labeledContainsNRL":false,"labeledNoNRL":true,"MRISafetyStatus":"MR Unsafe","rx":true,"otc":false,"contacts":{"customerContact":[]},"premarketSubmissions":{"premarketSubmission":[{"submissionNumber":"K181803","supplementNumber":"000"}]},"gmdnTerms":{"gmdn":[{"gmdnCode":"35886","gmdnPTName":"Body aspiration needle, single-use","gmdnPTDefinition":"A sterile, sharp bevel-edged, hollow tubular metal instrument designed to remove fluid from a body cavity or to obtain a biopsy specimen from a patient through aspiration; it is not dedicated to a particular part of the anatomy. The device is typically longer than a hypodermic needle and usually has a wider hub. It is not intended for administration of pharmaceuticals. This is a single-use device.","implantable":false,"gmdnCodeStatus":"Active"}]},"productCodes":{"fdaProductCode":[{"productCode":"KNW","productCodeName":"Instrument, Biopsy"}]},"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}