{"publicDeviceRecordKey":"c23b9e65-aee8-4012-b413-6cc65d70b8ce","publicVersionStatus":"Update","deviceRecordStatus":"Published","publicVersionNumber":2,"publicVersionDate":"2022-06-10T00:00:00.000Z","devicePublishDate":"2021-03-18T00:00:00.000Z","deviceCommDistributionEndDate":null,"deviceCommDistributionStatus":"In Commercial Distribution","identifiers":{"identifier":[{"deviceId":"00190376317618","deviceIdType":"Primary","deviceIdIssuingAgency":"GS1","containsDINumber":null,"pkgQuantity":null,"pkgDiscontinueDate":null,"pkgStatus":null,"pkgType":null}]},"brandName":"IdentiTi","versionModelNumber":"113-110-11226000","catalogNumber":null,"dunsNumber":"602465783","companyName":"ALPHATEC SPINE, INC.","deviceCount":1,"deviceDescription":"LIF Rasping Distractor, Straight, 11 x 22 mm","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":"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":"HTR","productCodeName":"RASP"}]},"deviceSizes":{"deviceSize":[{"sizeType":"Width","size":{"unit":"Millimeter","value":"22"},"sizeText":null,"sizeString":"Width: 22 Millimeter"},{"sizeType":"Height","size":{"unit":"Millimeter","value":"11"},"sizeText":null,"sizeString":"Height: 11 Millimeter"}]},"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":[]}}