{"publicDeviceRecordKey":"332e1b06-6318-498c-8434-cdb31c6959db","publicVersionStatus":"Update","deviceRecordStatus":"Published","publicVersionNumber":6,"publicVersionDate":"2024-12-24T00:00:00.000Z","devicePublishDate":"2014-09-22T00:00:00.000Z","deviceCommDistributionEndDate":"2021-01-05T00:00:00.000Z","deviceCommDistributionStatus":"Not in Commercial Distribution","identifiers":{"identifier":[{"deviceId":"04046963319625","deviceIdType":"Primary","deviceIdIssuingAgency":"GS1","containsDINumber":null,"pkgQuantity":null,"pkgDiscontinueDate":null,"pkgStatus":null,"pkgType":null}]},"brandName":"AESCULAP","versionModelNumber":"SW474T","catalogNumber":"SW474T","dunsNumber":"315018218","companyName":"Aesculap AG","deviceCount":1,"deviceDescription":"S4 MONOAXIAL SCREW 8.5X40MM CANULATED","DMExempt":false,"premarketExempt":false,"deviceHCTP":false,"deviceKit":false,"deviceCombinationProduct":false,"singleUse":true,"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(800)282-9000","phoneExtension":null,"email":"GUDID.BBMUS_Service@bbraun.com"}]},"gmdnTerms":{"gmdn":[{"gmdnCode":"46651","gmdnPTName":"Spinal bone screw, non-bioabsorbable","gmdnPTDefinition":"A small, threaded, implantable rod with a screw head and drive intended for internal spinal fixation by being screwed into the spine to hold a correction/stabilization device (e.g., rod, plate, tether) to bone; it is made of a material that is not chemically degraded or absorbed via natural body processes (e.g., surgical steel, titanium alloy, carbon fibre). It is available in various types (e.g., pedicle or transfacet, with a slotted, cross, star, or polygonal drive), and is typically used to provide immobilization and stabilization of spinal segments in the treatment of spinal instabilities or deformities. A screw head adaptor intended to stabilize a rod may be included with the screw.","implantable":true,"gmdnCodeStatus":"Active"}]},"productCodes":{"fdaProductCode":[{"productCode":"NKB","productCodeName":"Orthosis, spinal pedicle fixation, for degenerative disc disease"}]},"deviceSizes":{"deviceSize":[{"sizeType":"Device Size Text, specify","size":{"unit":"","value":""},"sizeText":"Length : 40.000 MM"},{"sizeType":"Device Size Text, specify","size":{"unit":"","value":""},"sizeText":"Diameter (mm) : 8.500 MM"}]},"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":[]}}