{"publicDeviceRecordKey":"83d36034-cbc7-4cc2-a82f-936199ded14e","publicVersionStatus":"Update","deviceRecordStatus":"Published","publicVersionNumber":2,"publicVersionDate":"2018-03-29T00:00:00.000Z","devicePublishDate":"2016-09-24T00:00:00.000Z","deviceCommDistributionEndDate":null,"deviceCommDistributionStatus":"In Commercial Distribution","identifiers":{"identifier":[{"deviceId":"00815384021202","deviceIdType":"Package","deviceIdIssuingAgency":"GS1","containsDINumber":"00815384021196","pkgQuantity":2,"pkgDiscontinueDate":null,"pkgStatus":"In Commercial Distribution","pkgType":"CASE"},{"deviceId":"00815384021196","deviceIdType":"Package","deviceIdIssuingAgency":"GS1","containsDINumber":"00815384021189","pkgQuantity":10,"pkgDiscontinueDate":null,"pkgStatus":"In Commercial Distribution","pkgType":"INNER PACK"},{"deviceId":"00815384021189","deviceIdType":"Primary","deviceIdIssuingAgency":"GS1","containsDINumber":null,"pkgQuantity":null,"pkgDiscontinueDate":null,"pkgStatus":null,"pkgType":null}]},"brandName":"OPTICS ONE","versionModelNumber":"4943-62","catalogNumber":"4943-62","dunsNumber":"790514756","companyName":"MEDICAL TECHNIQUE, INC.","deviceCount":1,"deviceDescription":"Zeiss OpMi Microscope Drape 42 x 62 - Sgl outside oculars\n","DMExempt":false,"premarketExempt":true,"deviceHCTP":false,"deviceKit":false,"deviceCombinationProduct":false,"singleUse":true,"lotBatch":true,"serialNumber":false,"manufacturingDate":false,"expirationDate":true,"donationIdNumber":false,"labeledContainsNRL":false,"labeledNoNRL":true,"MRISafetyStatus":"Labeling does not contain MRI Safety Information","rx":true,"otc":false,"contacts":{"customerContact":[{"phone":"520-733-7999","phoneExtension":null,"email":"INFO@MTIDRAPE.COM"}]},"gmdnTerms":{"gmdn":[{"gmdnCode":"45021","gmdnPTName":"Instrument/equipment drape, single-use, sterile","gmdnPTDefinition":"A sterile device made of natural and/or synthetic flexible materials intended to be used as a non-dedicated protective covering for various surgical and/or non-surgical instruments/equipment [e.g., surgical tray, operating room (OR) equipment table, endoscope and endoscopic instruments, surgical cameras and lasers], to provide a barrier against cross-contamination in various clinical settings. This is a single-use device.","implantable":false,"gmdnCodeStatus":"Obsolete"}]},"productCodes":{"fdaProductCode":[{"productCode":"HMW","productCodeName":"Drape, Microscope, Ophthalmic"}]},"deviceSizes":{"deviceSize":[]},"environmentalConditions":{"storageHandling":[]},"sterilization":{"deviceSterile":true,"sterilizationPriorToUse":true,"methodTypes":{"sterilizationMethod":["Ethylene Oxide"]}},"xmlns":"http://www.fda.gov/cdrh/gudid","xsi":"http://www.w3.org/2001/XMLSchema-instance","anomaly":null,"premarketSubmissions":{"premarketSubmission":[]}}