{"publicDeviceRecordKey":"0b634841-69df-40e8-80a0-f2c3875ab5a1","publicVersionStatus":"Update","deviceRecordStatus":"Published","publicVersionNumber":4,"publicVersionDate":"2025-10-29T00:00:00.000Z","devicePublishDate":"2022-09-26T00:00:00.000Z","deviceCommDistributionEndDate":null,"deviceCommDistributionStatus":"In Commercial Distribution","identifiers":{"identifier":[{"deviceId":"00887482098103","deviceIdType":"Primary","deviceIdIssuingAgency":"GS1","containsDINumber":null,"pkgQuantity":null,"pkgDiscontinueDate":null,"pkgStatus":null,"pkgType":null}]},"brandName":"Symmetry Surgical","versionModelNumber":"57-5246","catalogNumber":"57-5246","dunsNumber":"027680821","companyName":"ASPEN SURGICAL PRODUCTS, INC.","deviceCount":1,"deviceDescription":"Symmetry® Driver, Lumbar \u0026 Cervical Impactor/Graft, Narrow, 8 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":[{"phone":"+1 888-364-7004","phoneExtension":null,"email":"customerservice@symmetrysurgical.com"}]},"gmdnTerms":{"gmdn":[{"gmdnCode":"33968","gmdnPTName":"Surgical screwdriver, reusable","gmdnPTDefinition":"A non-powered tool intended to fit into a screw head (e.g., slotted, cross/hex head) for the application of rotation to introduce/remove a screw (e.g., craniofacial bone screw, dental screw) into/from a patient in association with a surgical procedure [e.g., orthopaedic, dental, computer assisted surgery (CAS), image registration]. It may also be used to connect/disconnect a device to/from another device attached to a patient (e.g., implant component, fiducial marker). The proximal end of the device may have a handle for manual use or a profiled tang that fits into an independent chuck or power driver; it is typically made of metallic and/or polymer materials. This is a reusable device.","implantable":false,"gmdnCodeStatus":"Active"}]},"productCodes":{"fdaProductCode":[{"productCode":"HWA","productCodeName":"Impactor"}]},"deviceSizes":{"deviceSize":[{"sizeType":"Length","size":{"unit":"Inch","value":"8.5"},"sizeText":null,"sizeString":"Length: 8.5 Inch"}]},"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":[]}}