{"publicDeviceRecordKey":"1e963e69-5ef6-4aca-b742-d5cb81d6282a","publicVersionStatus":"Update","deviceRecordStatus":"Published","publicVersionNumber":3,"publicVersionDate":"2025-10-29T00:00:00.000Z","devicePublishDate":"2021-02-25T00:00:00.000Z","deviceCommDistributionEndDate":null,"deviceCommDistributionStatus":"In Commercial Distribution","identifiers":{"identifier":[{"deviceId":"00192896106932","deviceIdType":"Primary","deviceIdIssuingAgency":"GS1","containsDINumber":null,"pkgQuantity":null,"pkgDiscontinueDate":null,"pkgStatus":null,"pkgType":null}]},"brandName":"House-Bellucci Ear Scissors","versionModelNumber":"469-093Q","catalogNumber":null,"dunsNumber":"040729840","companyName":"SONTEC INSTRUMENTS, INC.","deviceCount":1,"deviceDescription":"HOUSE-BELLUCCI EAR SCISSORS DELICATE 8 MILLIMETER BLADES STRAIGHT QUANTUM","DMExempt":false,"premarketExempt":true,"deviceHCTP":false,"deviceKit":false,"deviceCombinationProduct":false,"singleUse":false,"lotBatch":true,"serialNumber":false,"manufacturingDate":false,"expirationDate":false,"donationIdNumber":false,"labeledContainsNRL":false,"labeledNoNRL":true,"MRISafetyStatus":"Labeling does not contain MRI Safety Information","rx":true,"otc":false,"contacts":{"customerContact":[{"phone":"+1(800)821-7496","phoneExtension":null,"email":"info@sontecinstruments.com"}]},"gmdnTerms":{"gmdn":[{"gmdnCode":"33414","gmdnPTName":"Ear scissors, reusable","gmdnPTDefinition":"A long, thin, hand-held manual surgical instrument designed to cut tissue during ear surgery; it is not intended for insertion through an endoscope. Sometimes referred to as alligator scissors, it typically has a slender body (to allow for restricted access) and small shearing blades which are hinged at the distal (working) end. It is made of metal and available in various sizes/lengths; the blades may have carbide inserts along the cutting edges. This is a reusable device.","implantable":false,"gmdnCodeStatus":"Active"}]},"productCodes":{"fdaProductCode":[{"productCode":"JZB","productCodeName":"SCISSORS, EAR"}]},"deviceSizes":{"deviceSize":[]},"environmentalConditions":{"storageHandling":[]},"sterilization":{"deviceSterile":false,"sterilizationPriorToUse":true,"methodTypes":{"sterilizationMethod":["Dry Heat Sterilization","Moist Heat or Steam Sterilization"]}},"xmlns":"http://www.fda.gov/cdrh/gudid","xsi":"http://www.w3.org/2001/XMLSchema-instance","anomaly":null,"premarketSubmissions":{"premarketSubmission":[]}}