{"publicDeviceRecordKey":"4331570a-8fbc-4246-af18-55d9c3344c28","publicVersionStatus":"New","deviceRecordStatus":"Published","publicVersionNumber":1,"publicVersionDate":"2023-12-26T00:00:00.000Z","devicePublishDate":"2023-12-18T00:00:00.000Z","deviceCommDistributionEndDate":null,"deviceCommDistributionStatus":"In Commercial Distribution","identifiers":{"identifier":[{"deviceId":"G586N681603CC0","deviceIdType":"Primary","deviceIdIssuingAgency":"HIBCC","containsDINumber":null,"pkgQuantity":null,"pkgDiscontinueDate":null,"pkgStatus":null,"pkgType":null}]},"brandName":"Novo Surgical","versionModelNumber":"N6816-03CC","catalogNumber":"N6816-03CC","dunsNumber":"033029433","companyName":"NOVO SURGICAL, INC.","deviceCount":1,"deviceDescription":"ceramic cut spurling-kerrison rongeur, thin footplates, large handles, 15.0 mm opening, black ceramic coat, 40 degrees up, 2.0 mm bite, 11\" (27.9 cm)","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":false,"MRISafetyStatus":"Labeling does not contain MRI Safety Information","rx":true,"otc":false,"contacts":{"customerContact":[{"phone":"+1(877)860-6686","phoneExtension":null,"email":"info@novosurgical.com"}]},"gmdnTerms":{"gmdn":[{"gmdnCode":"64337","gmdnPTName":"Bone-coring punch, reusable","gmdnPTDefinition":"A hand-held manual surgical instrument designed to cut out (core) sections of bone, or a combination of bone and soft-tissue, during surgery. It consists of a handle and a cylindrical distal tip which has a bevelled, sharp cutting edge, which when cored into the bone and gently rotated will penetrate and cut through the bone allowing that section to be removed. This is a reusable device.","implantable":false,"gmdnCodeStatus":"Active"}]},"productCodes":{"fdaProductCode":[{"productCode":"HTX","productCodeName":"RONGEUR"}]},"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":[]}}