{"publicDeviceRecordKey":"3cb214fb-f7bc-4c85-b5bb-d8d23b85c1e3","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":"B091121310","deviceIdType":"Primary","deviceIdIssuingAgency":"HIBCC","containsDINumber":null,"pkgQuantity":null,"pkgDiscontinueDate":null,"pkgStatus":null,"pkgType":null}]},"brandName":"Clip-on Spielmann","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":false,"serialNumber":false,"manufacturingDate":false,"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":"46490","gmdnPTName":"Spectacle lens occluder","gmdnPTDefinition":"A thin, plastic, flap-like device that is clipped onto the upper frame of a pair of existing spectacles (eyeware) to block vision through the spectacle lens. It is typically made of plastic and is available in preformed, leaf-shaped, disks, usually with a pair of clip on hinges on its top edge; it is subsequently applied to the exterior of the lens. The device is often used for children and is intended to be used prophylactically (e.g., to prevent amblyopia -- impairment of vision without apparent disease) and/or therapeutically [e.g., to treat squinting, double vision (diplopia), and problems due to absence of a natural lens (aphakia)]. 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":[]}}