{"publicDeviceRecordKey":"12b909d7-f4fe-4dee-9c2b-6a48b78c8b0c","publicVersionStatus":"Update","deviceRecordStatus":"Published","publicVersionNumber":3,"publicVersionDate":"2025-10-29T00:00:00.000Z","devicePublishDate":"2024-08-20T00:00:00.000Z","deviceCommDistributionEndDate":"2025-01-09T00:00:00.000Z","deviceCommDistributionStatus":"Not in Commercial Distribution","identifiers":{"identifier":[{"deviceId":"00887482114223","deviceIdType":"Primary","deviceIdIssuingAgency":"GS1","containsDINumber":null,"pkgQuantity":null,"pkgDiscontinueDate":null,"pkgStatus":null,"pkgType":null}]},"brandName":"Symmetry Surgical®","versionModelNumber":"61-0438","catalogNumber":"61-0438","dunsNumber":"027680821","companyName":"ASPEN SURGICAL PRODUCTS, INC.","deviceCount":1,"deviceDescription":"Symmetry® Fenestrometer, Paparella, 1 mm \u0026 0.5 mm Markings, 4 mm Head, 6 1/2 in","DMExempt":true,"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":true,"otc":false,"contacts":{"customerContact":[]},"gmdnTerms":{"gmdn":[{"gmdnCode":"33400","gmdnPTName":"Mastoid gauge","gmdnPTDefinition":"A manual surgical instrument designed for introduction into and calibration of the mastoid bone antrum during surgical procedures (e.g., mastoidectomy). It is typically a slender, hand-held, calibrated (e.g., in millimetres) metallic device with an angled blunt distal end (also known as a searcher or seeker). This is a reusable device.","implantable":false,"gmdnCodeStatus":"Active"}]},"productCodes":{"fdaProductCode":[{"productCode":"JYJ","productCodeName":"Gauge, Measuring"}]},"deviceSizes":{"deviceSize":[]},"environmentalConditions":{"storageHandling":[]},"sterilization":{"deviceSterile":false,"sterilizationPriorToUse":true,"methodTypes":{"sterilizationMethod":["Moist Heat or Steam Sterilization"]}},"xmlns":"http://www.fda.gov/cdrh/gudid","xsi":"http://www.w3.org/2001/XMLSchema-instance","anomaly":null,"premarketSubmissions":{"premarketSubmission":[]}}