{"publicDeviceRecordKey":"0bc3f877-e37d-471c-89a4-02de8f25a262","publicVersionStatus":"New","deviceRecordStatus":"Published","publicVersionNumber":1,"publicVersionDate":"2026-05-11T00:00:00.000Z","devicePublishDate":"2026-05-03T00:00:00.000Z","deviceCommDistributionEndDate":null,"deviceCommDistributionStatus":"In Commercial Distribution","identifiers":{"identifier":[{"deviceId":"B945MFLIPM5000","deviceIdType":"Primary","deviceIdIssuingAgency":"HIBCC","containsDINumber":null,"pkgQuantity":null,"pkgDiscontinueDate":null,"pkgStatus":null,"pkgType":null}]},"brandName":"Bernell","versionModelNumber":"MFLIP-5.00","catalogNumber":"MFLIP-5.00","dunsNumber":"175947340","companyName":"Bernell","deviceCount":1,"deviceDescription":"Monocular Flipper -5.00D","DMExempt":false,"premarketExempt":true,"deviceHCTP":false,"deviceKit":false,"deviceCombinationProduct":false,"singleUse":false,"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":true,"contacts":{"customerContact":[]},"gmdnTerms":{"gmdn":[{"gmdnCode":"64350","gmdnPTName":"Vision testing/training flipper","gmdnPTDefinition":"A device in the form of flipper lenses (two lenses on either side of a rotatable stem) intended to be used for the diagnosis and treatment of ophthalmic accommodation disorders. It consists of binocular spherical plus/minus lenses that can quickly be flipped from plus to minus, and which can be used by a healthcare professional for diagnosis or by a patient for self-training. This is a reusable device.","implantable":false,"gmdnCodeStatus":"Active"}]},"productCodes":{"fdaProductCode":[{"productCode":"HPB","productCodeName":"Clip, Lens, Trial, 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":[]}}