{"publicDeviceRecordKey":"ccefdb99-eef9-4de1-ad6c-4bba30d8ea44","publicVersionStatus":"New","deviceRecordStatus":"Published","publicVersionNumber":1,"publicVersionDate":"2025-06-17T00:00:00.000Z","devicePublishDate":"2025-06-09T00:00:00.000Z","deviceCommDistributionEndDate":null,"deviceCommDistributionStatus":"In Commercial Distribution","identifiers":{"identifier":[{"deviceId":"00840343726331","deviceIdType":"Primary","deviceIdIssuingAgency":"GS1","containsDINumber":null,"pkgQuantity":null,"pkgDiscontinueDate":null,"pkgStatus":null,"pkgType":null}]},"brandName":"GEN2","versionModelNumber":"G2E11043B","catalogNumber":"G2E11043B","dunsNumber":"080402644","companyName":"SURGIX MEDICAL LLC","deviceCount":1,"deviceDescription":"FARR SPEC 6X7 EBON OV/OBL\n","DMExempt":false,"premarketExempt":false,"deviceHCTP":false,"deviceKit":false,"deviceCombinationProduct":false,"singleUse":false,"lotBatch":true,"serialNumber":false,"manufacturingDate":false,"expirationDate":false,"donationIdNumber":false,"labeledContainsNRL":false,"labeledNoNRL":false,"MRISafetyStatus":"Labeling does not contain MRI Safety Information","rx":true,"otc":false,"contacts":{"customerContact":[{"phone":"888-247-0477","phoneExtension":null,"email":"customerservice@surgixmedical.com"}]},"gmdnTerms":{"gmdn":[{"gmdnCode":"33395","gmdnPTName":"Ear speculum, reusable","gmdnPTDefinition":"A rigid plastic or metal tube that is cone-shaped (i.e., it tapers down from a standard instrument fitting size to a small opening) and is either hand-held and manually inserted, or fitted onto a compatible otoscope, and then inserted into the ear canal to create a channel for examination, suction, irrigation, or the insertion of another surgical device during an ear/nose/throat (ENT) procedure. It may in addition be intended for use with an audiometer and might also be referred to as an ear cannula or probe. This is a reusable device.","implantable":false,"gmdnCodeStatus":"Active"}]},"productCodes":{"fdaProductCode":[{"productCode":"EPY","productCodeName":"Speculum, Ent"}]},"deviceSizes":{"deviceSize":[{"sizeType":"Length","size":{"unit":"Millimeter","value":"6"},"sizeText":null,"sizeString":"Length: 6 Millimeter"},{"sizeType":"Width","size":{"unit":"Millimeter","value":"7"},"sizeText":null,"sizeString":"Width: 7 Millimeter"}]},"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":[]}}