{"publicDeviceRecordKey":"64e9ef14-4d2a-47f3-ab50-2ab89d3a1095","publicVersionStatus":"Update","deviceRecordStatus":"Published","publicVersionNumber":2,"publicVersionDate":"2022-06-10T00:00:00.000Z","devicePublishDate":"2021-09-23T00:00:00.000Z","deviceCommDistributionEndDate":null,"deviceCommDistributionStatus":"In Commercial Distribution","identifiers":{"identifier":[{"deviceId":"M719GC3RHS080","deviceIdType":"Primary","deviceIdIssuingAgency":"HIBCC","containsDINumber":null,"pkgQuantity":null,"pkgDiscontinueDate":null,"pkgStatus":null,"pkgType":null}]},"brandName":"3DP Cervical Interbody System","versionModelNumber":"1","catalogNumber":"GC3-RH-S08","dunsNumber":"017921066","companyName":"Genesys Orthopedics Systems LLC","deviceCount":1,"deviceDescription":"Small 8mm 3DP Cervical Rasp with Handle ","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":"5123817070","phoneExtension":null,"email":"info@genesysspine.com"}]},"premarketSubmissions":{"premarketSubmission":[{"submissionNumber":"K191489","supplementNumber":"000"}]},"gmdnTerms":{"gmdn":[{"gmdnCode":"35559","gmdnPTName":"Bone file/rasp, manual, reusable","gmdnPTDefinition":"A hand-held manual surgical instrument with a surface(s) of coarse and/or fine grooves or teeth designed to scrape and smooth the surface of bone during a surgical procedure. The device is typically a one-piece instrument with grooves/teeth along all or part of its working end(s). It is available in a variety of sizes and working end designs, including straight and curved ends and often double-ended with a central handle. It is not dedicated for use at a specific anatomy (e.g., sinus, ear) and it is made of metal [e.g., stainless steel, titanium (Ti)]. This is a reusable device.","implantable":false,"gmdnCodeStatus":"Active"}]},"productCodes":{"fdaProductCode":[{"productCode":"OVE","productCodeName":"Intervertebral Fusion Device With Integrated Fixation, Cervical"},{"productCode":"ODP","productCodeName":"Intervertebral Fusion Device With Bone Graft, Cervical"}]},"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}