{"publicDeviceRecordKey":"8d12e622-5250-4fa2-9ee5-eea9e8d7c58e","publicVersionStatus":"Update","deviceRecordStatus":"Published","publicVersionNumber":2,"publicVersionDate":"2018-03-29T00:00:00.000Z","devicePublishDate":"2017-10-12T00:00:00.000Z","deviceCommDistributionEndDate":null,"deviceCommDistributionStatus":"In Commercial Distribution","identifiers":{"identifier":[{"deviceId":"08714729953371","deviceIdType":"Primary","deviceIdIssuingAgency":"GS1","containsDINumber":null,"pkgQuantity":null,"pkgDiscontinueDate":null,"pkgStatus":null,"pkgType":null}]},"brandName":"NaviGuide","versionModelNumber":"M0067001320","catalogNumber":null,"dunsNumber":"021717889","companyName":"BOSTON SCIENTIFIC CORPORATION","deviceCount":1,"deviceDescription":"Percutaneous Access Needle","DMExempt":false,"premarketExempt":true,"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":[]},"gmdnTerms":{"gmdn":[{"gmdnCode":"61503","gmdnPTName":"Nephrostomy catheter introduction needle","gmdnPTDefinition":"A sterile, sharp bevel-edged, hollow tubular metal instrument designed to make the initial percutaneous puncture to access the kidney during nephrostomy catheter introduction for urinary drainage. It is intended to enable introduction of a guidewire (Seldinger technique); the therapeutic or diagnostic aspiration of fluids may be achieved during its placement. It may include an intraluminal stylet intended to add rigidity to the needle during introduction. This is a single-use device.","implantable":false,"gmdnCodeStatus":"Active"}]},"productCodes":{"fdaProductCode":[{"productCode":"GBO","productCodeName":"CATHETER, NEPHROSTOMY, GENERAL \u0026 PLASTIC SURGERY"}]},"deviceSizes":{"deviceSize":[{"sizeType":"Device Size Text, specify","size":{"unit":"","value":""},"sizeText":"1.3 mm Diameter"},{"sizeType":"Device Size Text, specify","size":{"unit":"","value":""},"sizeText":"16 cm Length"},{"sizeType":"Device Size Text, specify","size":{"unit":"","value":""},"sizeText":"18 ga Diameter"}]},"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":[]}}