{"publicDeviceRecordKey":"58f0f082-8b72-42de-9f88-743f3376670b","publicVersionStatus":"Update","deviceRecordStatus":"Published","publicVersionNumber":4,"publicVersionDate":"2020-11-06T00:00:00.000Z","devicePublishDate":"2016-09-24T00:00:00.000Z","deviceCommDistributionEndDate":null,"deviceCommDistributionStatus":"In Commercial Distribution","identifiers":{"identifier":[{"deviceId":"00827002145474","deviceIdType":"Primary","deviceIdIssuingAgency":"GS1","containsDINumber":null,"pkgQuantity":null,"pkgDiscontinueDate":null,"pkgStatus":null,"pkgType":null}]},"brandName":"Rutner","versionModelNumber":"G14547","catalogNumber":"014255","dunsNumber":"042823948","companyName":"COOK INCORPORATED","deviceCount":1,"deviceDescription":"Rutner Balloon Dilation Helical Stone Extractor","DMExempt":false,"premarketExempt":true,"deviceHCTP":false,"deviceKit":false,"deviceCombinationProduct":false,"singleUse":true,"lotBatch":true,"serialNumber":false,"manufacturingDate":true,"expirationDate":true,"donationIdNumber":false,"labeledContainsNRL":false,"labeledNoNRL":false,"MRISafetyStatus":"Labeling does not contain MRI Safety Information","rx":true,"otc":false,"contacts":{"customerContact":[{"phone":"+1(812)330-5494","phoneExtension":null,"email":"sharedservices@cookmedical.com"}]},"gmdnTerms":{"gmdn":[{"gmdnCode":"46452","gmdnPTName":"Biliary/urinary stone retrieval basket, single-use","gmdnPTDefinition":"A flexible, manual instrument designed to trap/retrieve biliary and/or urinary stones (gallbladder and/or renal/ureteric calculi) from the body during an open surgical and/or endoscopic/laparoscopic procedure [e.g., choledochoscopy, endoscopic retrograde cholangiopancreatography (ERCP)]; it is not intended to fragment/crush. It is typically designed with a long, thin, flexible shank that has an expandable basket of wire (typically metallic) at its distal end in which the stones are caught. This is a single-use device.","implantable":false,"gmdnCodeStatus":"Active"}]},"productCodes":{"fdaProductCode":[{"productCode":"FFL","productCodeName":"DISLODGER, STONE, BASKET, URETERAL, METAL"}]},"deviceSizes":{"deviceSize":[]},"environmentalConditions":{"storageHandling":[{"storageHandlingType":"Special Storage Condition, Specify","storageHandlingHigh":{"unit":"","value":""},"storageHandlingLow":{"unit":"","value":""},"storageHandlingSpecialConditionText":"Store in dark, dry, cool place."}]},"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":[]}}