{"publicDeviceRecordKey":"cf75fd95-55a3-4346-9a2a-0dfbd1c0b0d4","publicVersionStatus":"New","deviceRecordStatus":"Published","publicVersionNumber":1,"publicVersionDate":"2019-06-10T00:00:00.000Z","devicePublishDate":"2019-06-01T00:00:00.000Z","deviceCommDistributionEndDate":null,"deviceCommDistributionStatus":"In Commercial Distribution","identifiers":{"identifier":[{"deviceId":"CS4308","deviceIdType":"Primary","deviceIdIssuingAgency":"HIBCC","containsDINumber":null,"pkgQuantity":null,"pkgDiscontinueDate":null,"pkgStatus":null,"pkgType":null}]},"brandName":"Endoch","versionModelNumber":"CS-430T","catalogNumber":"CS-430T","dunsNumber":"241382683","companyName":"Endoch Inc","deviceCount":1,"deviceDescription":"Video Colonoscope\n","DMExempt":false,"premarketExempt":false,"deviceHCTP":false,"deviceKit":false,"deviceCombinationProduct":false,"singleUse":true,"lotBatch":false,"serialNumber":false,"manufacturingDate":false,"expirationDate":false,"donationIdNumber":false,"labeledContainsNRL":false,"labeledNoNRL":false,"MRISafetyStatus":"Labeling does not contain MRI Safety Information","rx":false,"otc":false,"contacts":{"customerContact":[]},"gmdnTerms":{"gmdn":[{"gmdnCode":"62159","gmdnPTName":"Flexible video colonoscope, single-use","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 typically to examine the colon (e.g., diseases on the colon) or colon contents (e.g., blood in stools). It may be designed to be manually inserted or designed with features to assist/power insertion (e.g., push/pull double-balloons, powered propelling mechanism). Anatomical images are transmitted to the user by a video system with an image sensor chip at the distal end of the endoscope and the images showing on a monitor. This is a single-use device.","implantable":false,"gmdnCodeStatus":"Active"},{"gmdnCode":"36117","gmdnPTName":"Flexible video colonoscope, reusable","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 a monitor for viewing by a video system with a charge-coupled device (CCD) chip at the distal end of the endoscope. 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":true,"sterilizationPriorToUse":false,"methodTypes":{"sterilizationMethod":[]}},"xmlns":"http://www.fda.gov/cdrh/gudid","xsi":"http://www.w3.org/2001/XMLSchema-instance","anomaly":null,"premarketSubmissions":{"premarketSubmission":[]}}