{"publicDeviceRecordKey":"8bb92031-eb24-40f0-85a3-6c0920ca0d28","publicVersionStatus":"New","deviceRecordStatus":"Published","publicVersionNumber":1,"publicVersionDate":"2020-09-28T00:00:00.000Z","devicePublishDate":"2020-09-19T00:00:00.000Z","deviceCommDistributionEndDate":null,"deviceCommDistributionStatus":"In Commercial Distribution","identifiers":{"identifier":[{"deviceId":"00811801034800","deviceIdType":"Primary","deviceIdIssuingAgency":"GS1","containsDINumber":null,"pkgQuantity":null,"pkgDiscontinueDate":null,"pkgStatus":null,"pkgType":null}]},"brandName":"General Instruments","versionModelNumber":"CI-10197-10","catalogNumber":null,"dunsNumber":"602465783","companyName":"ALPHATEC SPINE, INC.","deviceCount":1,"deviceDescription":"Graft Containment Slides w/Ledge - Untracked","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(760)431-9286","phoneExtension":null,"email":"Regulatory@alphatecspine.com"}]},"gmdnTerms":{"gmdn":[{"gmdnCode":"44874","gmdnPTName":"Orthopaedic graft guide","gmdnPTDefinition":"A device used to protect a graft during delivery to the site of implantation. The graft is inserted into the device, which allows introduction and manoeuvring into difficult sites [e.g., during delivery into the tibial and femoral tunnel during anterior cruciate ligament (ACL) reconstruction surgery]. It is typically tubular-shaped, made of sturdy materials (e.g., stainless steel, hard plastic) and comes in varying sizes. This is a single-use device.","implantable":false,"gmdnCodeStatus":"Active"}]},"productCodes":{"fdaProductCode":[{"productCode":"LXH","productCodeName":"ORTHOPEDIC MANUAL SURGICAL INSTRUMENT"}]},"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":[]}}