{"publicDeviceRecordKey":"326c80f7-1d8f-4d46-ac60-ca6d21dcbbe3","publicVersionStatus":"New","deviceRecordStatus":"Published","publicVersionNumber":1,"publicVersionDate":"2022-08-09T00:00:00.000Z","devicePublishDate":"2022-08-01T00:00:00.000Z","deviceCommDistributionEndDate":null,"deviceCommDistributionStatus":"In Commercial Distribution","identifiers":{"identifier":[{"deviceId":"08717872034447","deviceIdType":"Primary","deviceIdIssuingAgency":"GS1","containsDINumber":null,"pkgQuantity":null,"pkgDiscontinueDate":null,"pkgStatus":null,"pkgType":null}]},"brandName":"EVA NEXUS™, Phaco vitrectomy system including laser with SMA connector","versionModelNumber":"9000.COMU3","catalogNumber":null,"dunsNumber":"407522184","companyName":"D.O.R.C. Dutch Ophthalmic Research Center (International) B.V.","deviceCount":1,"deviceDescription":null,"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":"Labeling does not contain MRI Safety Information","rx":true,"otc":false,"contacts":{"customerContact":[]},"premarketSubmissions":{"premarketSubmission":[{"submissionNumber":"K213467","supplementNumber":"000"}]},"gmdnTerms":{"gmdn":[{"gmdnCode":"45072","gmdnPTName":"Phacoemulsification/vitrectomy system","gmdnPTDefinition":"An assembly of ophthalmic devices intended to deliver energies (e.g., ultrasonic, piezoelectric, high frequency current) through dedicated handpieces and tips that are introduced through an incision or incisions made in the eye, for the purpose of performing phacoemulsification and/or vitrectomy (the removal and replacement of cataracts and/or the vitreous in anterior and posterior segment surgical procedures). It typically consists of a generator providing the energy, irrigation and suction system for the removal of the debris, a tamponade system (e.g., silicone and air), diathermy device, intraocular illuminator, handpieces and cables, the tips/needles/electrodes, and a foot control.","implantable":false,"gmdnCodeStatus":"Active"}]},"productCodes":{"fdaProductCode":[{"productCode":"HQC","productCodeName":"Unit, Phacofragmentation"},{"productCode":"HQE","productCodeName":"Instrument, Vitreous Aspiration And Cutting, Ac-Powered"},{"productCode":"HQF","productCodeName":"Laser, 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}