{"publicDeviceRecordKey":"7f5e9ebe-d563-40a8-809c-ba509f4c6fc8","publicVersionStatus":"New","deviceRecordStatus":"Published","publicVersionNumber":1,"publicVersionDate":"2019-08-29T00:00:00.000Z","devicePublishDate":"2019-08-21T00:00:00.000Z","deviceCommDistributionEndDate":null,"deviceCommDistributionStatus":"In Commercial Distribution","identifiers":{"identifier":[{"deviceId":"04049539104403","deviceIdType":"Primary","deviceIdIssuingAgency":"GS1","containsDINumber":null,"pkgQuantity":null,"pkgDiscontinueDate":null,"pkgStatus":null,"pkgType":null}]},"brandName":"CALLISTO eye","versionModelNumber":"3.6.2","catalogNumber":null,"dunsNumber":"342228620","companyName":"Carl Zeiss Meditec AG","deviceCount":1,"deviceDescription":null,"DMExempt":false,"premarketExempt":false,"deviceHCTP":false,"deviceKit":false,"deviceCombinationProduct":false,"singleUse":false,"lotBatch":true,"serialNumber":false,"manufacturingDate":true,"expirationDate":false,"donationIdNumber":false,"labeledContainsNRL":false,"labeledNoNRL":false,"MRISafetyStatus":"Labeling does not contain MRI Safety Information","rx":true,"otc":false,"contacts":{"customerContact":[]},"gmdnTerms":{"gmdn":[{"gmdnCode":"58117","gmdnPTName":"Operating room audiovisual data/device management system","gmdnPTDefinition":"A mains electricity (AC-powered) device assembly designed to provide operating room (OR) staff with a single point of management to operate electromechanical/electronic medical devices of different makes during surgery. It is a computer-based integrated hardware/software application that typically consists of a base unit (outside the sterile field or the OR) to which all device cabling is connected, and software that runs on an off-the-shelf computer with a touchscreen (in the OR). The system is intended to manipulate devices such as OR lights, OR tables, cameras, video endoscope images, and monitors; it may also be used to manage patient data from these devices.","implantable":false,"gmdnCodeStatus":"Active"}]},"productCodes":{"fdaProductCode":[{"productCode":"NFJ","productCodeName":"System, Image Management, Ophthalmic"}]},"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,"premarketSubmissions":{"premarketSubmission":[]}}