{"publicDeviceRecordKey":"4076d534-4b9e-4c80-abce-b155441d4d75","publicVersionStatus":"Update","deviceRecordStatus":"Published","publicVersionNumber":2,"publicVersionDate":"2026-03-23T00:00:00.000Z","devicePublishDate":"2023-11-17T00:00:00.000Z","deviceCommDistributionEndDate":null,"deviceCommDistributionStatus":"In Commercial Distribution","identifiers":{"identifier":[{"deviceId":"B369MES01035","deviceIdType":"Primary","deviceIdIssuingAgency":"HIBCC","containsDINumber":null,"pkgQuantity":null,"pkgDiscontinueDate":null,"pkgStatus":null,"pkgType":null}]},"brandName":"MEDISONO","versionModelNumber":"Medisono END-VYS EC-2200 Colonoscope","catalogNumber":"MES01035","dunsNumber":"079686615","companyName":"Medisono, LLC","deviceCount":1,"deviceDescription":"Medisono END-VYS EC-2200 Colonoscope\n","DMExempt":false,"premarketExempt":false,"deviceHCTP":false,"deviceKit":false,"deviceCombinationProduct":false,"singleUse":false,"lotBatch":false,"serialNumber":true,"manufacturingDate":true,"expirationDate":false,"donationIdNumber":false,"labeledContainsNRL":false,"labeledNoNRL":false,"MRISafetyStatus":"MR Unsafe","rx":false,"otc":false,"contacts":{"customerContact":[{"phone":"13054063931","phoneExtension":null,"email":"nicolo.briante@strenamedical.com"}]},"premarketSubmissions":{"premarketSubmission":[{"submissionNumber":"K211882","supplementNumber":"000"}]},"gmdnTerms":{"gmdn":[{"gmdnCode":"34966","gmdnPTName":"Flexible fibreoptic colonoscope","gmdnPTDefinition":"An endoscope with a flexible inserted portion intended for the visual examination and treatment of the entire colon [lower gastrointestinal (GI) tract]. It is inserted through the anus during colonoscopy. Anatomical images are transmitted to the user by the device through a fibreoptic bundle. This device is commonly used to examine the lining of the colon or to evaluate altered bowel habits, colonic cancer, polyps, diverticular disease, occult or frank blood in stools, or unexplained anaemia. This is a reusable device.","implantable":false,"gmdnCodeStatus":"Active"}]},"productCodes":{"fdaProductCode":[{"productCode":"FDF","productCodeName":"Colonoscope And Accessories, Flexible/Rigid"}]},"deviceSizes":{"deviceSize":[]},"environmentalConditions":{"storageHandling":[]},"sterilization":{"deviceSterile":false,"sterilizationPriorToUse":false,"methodTypes":{"sterilizationMethod":[]}},"xmlns":"http://www.fda.gov/cdrh/gudid","xsi":"http://www.w3.org/2001/XMLSchema-instance","anomaly":null}