{"publicDeviceRecordKey":"257e8304-bd59-433f-aa7a-1cce3b224a84","publicVersionStatus":"New","deviceRecordStatus":"Published","publicVersionNumber":1,"publicVersionDate":"2023-07-13T00:00:00.000Z","devicePublishDate":"2023-07-05T00:00:00.000Z","deviceCommDistributionEndDate":null,"deviceCommDistributionStatus":"In Commercial Distribution","identifiers":{"identifier":[{"deviceId":"B091152030","deviceIdType":"Primary","deviceIdIssuingAgency":"HIBCC","containsDINumber":null,"pkgQuantity":null,"pkgDiscontinueDate":null,"pkgStatus":null,"pkgType":null}]},"brandName":"Flashing Butterfly Fixation Stick","versionModelNumber":"1","catalogNumber":null,"dunsNumber":"002373249","companyName":"Gulden Ophthalmics Inc.","deviceCount":1,"deviceDescription":null,"DMExempt":false,"premarketExempt":true,"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":false,"otc":false,"contacts":{"customerContact":[]},"gmdnTerms":{"gmdn":[{"gmdnCode":"64186","gmdnPTName":"Ophthalmic examination target holder","gmdnPTDefinition":"A supportive device intended to be used during an ophthalmic examination (e.g., general eye test, dynamic retinoscopy, ophthalmoscopy) to hold a patient’s visual target in direct line of sight of the clinician, facilitating clinical observations and measurements along the visual axis. It is designed as a frame to support the visual target (e.g., mobile phone, eye test card) and has an opening through which eye observations are made; it typically includes connectors/clamps for fixation to an ophthalmic examination station and ophthalmic instruments. This device is typically used to help engage the patient when cooperation is difficult (e.g., a child or a person with a disability).","implantable":false,"gmdnCodeStatus":"Active"}]},"productCodes":{"fdaProductCode":[{"productCode":"HPL","productCodeName":"Device, Fixation, Ac-Powered, 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":[]}}