{"publicDeviceRecordKey":"3f4ad9da-b6d6-4e1f-9835-776607a3de00","publicVersionStatus":"New","deviceRecordStatus":"Published","publicVersionNumber":1,"publicVersionDate":"2026-04-22T00:00:00.000Z","devicePublishDate":"2026-04-14T00:00:00.000Z","deviceCommDistributionEndDate":null,"deviceCommDistributionStatus":"In Commercial Distribution","identifiers":{"identifier":[{"deviceId":"26970057571021","deviceIdType":"Package","deviceIdIssuingAgency":"GS1","containsDINumber":"06970057571027","pkgQuantity":2,"pkgDiscontinueDate":null,"pkgStatus":"In Commercial Distribution","pkgType":"box"},{"deviceId":"06970057571027","deviceIdType":"Primary","deviceIdIssuingAgency":"GS1","containsDINumber":null,"pkgQuantity":null,"pkgDiscontinueDate":null,"pkgStatus":null,"pkgType":null},{"deviceId":"56970057571022","deviceIdType":"Package","deviceIdIssuingAgency":"GS1","containsDINumber":"06970057571027","pkgQuantity":20,"pkgDiscontinueDate":null,"pkgStatus":"In Commercial Distribution","pkgType":"carton"}]},"brandName":"Stone Extraction Balloon","versionModelNumber":"VDK-BAL-23-11/13/15-B","catalogNumber":null,"dunsNumber":"544430136","companyName":"Jiangsu Vedkang Medical Science and Technology Co.,Ltd.","deviceCount":1,"deviceDescription":null,"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":false,"MRISafetyStatus":"Labeling does not contain MRI Safety Information","rx":true,"otc":false,"contacts":{"customerContact":[]},"premarketSubmissions":{"premarketSubmission":[{"submissionNumber":"K232752","supplementNumber":"000"}]},"gmdnTerms":{"gmdn":[{"gmdnCode":"46715","gmdnPTName":"ERCP catheter, balloon, non-electrical, stone-retrieval","gmdnPTDefinition":"A flexible, tubular, non-electrical device with an inflatable multi-sizing balloon at the distal end designed for the removal of stones (calculi) from the biliary tract during endoscopic retrograde cholangiopancreatography (ERCP). It is inserted through the working channel of an endoscope, typically beyond the stones, where the balloon is inflated and retracted to push the stones out. It typically has more than one lumen to allow, e.g., use of a guidewire while simultaneously enabling the injection of a contrast medium into the biliary tree for fluoroscopic visualization of the bile ducts. This is a single-use device.","implantable":false,"gmdnCodeStatus":"Active"}]},"productCodes":{"fdaProductCode":[{"productCode":"GCA","productCodeName":"Biliary Catheter For Stone Removal That May Also Allow For Irrigation And Contrast Injection"}]},"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}