{"publicDeviceRecordKey":"795cc169-9dbf-4467-b7aa-9939c5283e8f","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":"B369MES01040","deviceIdType":"Primary","deviceIdIssuingAgency":"HIBCC","containsDINumber":null,"pkgQuantity":null,"pkgDiscontinueDate":null,"pkgStatus":null,"pkgType":null}]},"brandName":"MEDISONO","versionModelNumber":"Medisono END-VYS  EG-550Z Zoom Scopes","catalogNumber":"MES01040","dunsNumber":"079686615","companyName":"Medisono, LLC","deviceCount":1,"deviceDescription":"Medisono END-VYS  EG-550Z Zoom Scopes\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":"35088","gmdnPTName":"Flexible fibreoptic gastroscope","gmdnPTDefinition":"An endoscope with a flexible inserted portion intended for the visual examination and treatment of the oesophagus and the stomach. It is inserted into the body through the mouth during gastroscopy. Anatomical images are transmitted to the user by the device through a fibreoptic bundle. This device is commonly used in the evaluation or treatment of unusual abdominal pain, bleeding, cancer, chronic heartburn, polyps, gastritis, ulcers, or hiatal hernia. Physicians may also use the device to obtain biopsies or perform other procedures. This is a reusable device.","implantable":false,"gmdnCodeStatus":"Active"}]},"productCodes":{"fdaProductCode":[{"productCode":"NWB","productCodeName":"Endoscope, Accessories, Narrow Band Spectrum"}]},"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}