{"publicDeviceRecordKey":"6390ac3a-1ee4-40c6-a761-43d575c2286e","publicVersionStatus":"New","deviceRecordStatus":"Published","publicVersionNumber":1,"publicVersionDate":"2022-09-12T00:00:00.000Z","devicePublishDate":"2022-09-02T00:00:00.000Z","deviceCommDistributionEndDate":null,"deviceCommDistributionStatus":"In Commercial Distribution","identifiers":{"identifier":[{"deviceId":"08055060728786","deviceIdType":"Primary","deviceIdIssuingAgency":"GS1","containsDINumber":null,"pkgQuantity":null,"pkgDiscontinueDate":null,"pkgStatus":null,"pkgType":null}]},"brandName":"\"Alphatec  (Manufacturer:Tsunami Medical)\"","versionModelNumber":"TVN 11/15","catalogNumber":null,"dunsNumber":"435819002","companyName":"TSUNAMI SRL","deviceCount":1,"deviceDescription":null,"DMExempt":false,"premarketExempt":true,"deviceHCTP":false,"deviceKit":false,"deviceCombinationProduct":false,"singleUse":true,"lotBatch":true,"serialNumber":true,"manufacturingDate":true,"expirationDate":true,"donationIdNumber":false,"labeledContainsNRL":false,"labeledNoNRL":false,"MRISafetyStatus":"Labeling does not contain MRI Safety Information","rx":false,"otc":false,"contacts":{"customerContact":[]},"gmdnTerms":{"gmdn":[{"gmdnCode":"46750","gmdnPTName":"Vertebral bone biopsy procedure kit, single-use","gmdnPTDefinition":"A collection of sterile devices, equipment, and supplies used to obtain a bone specimen from the vertebrae of a patient (the bony segments of the spinal column) for histological analysis. It typically contains a metal cannula which can have various tip designs (e.g., bevelled, pyramidal, scoop-, or diamond-shaped) and stylet(s), a biopsy needle, an obturator, a needle holder, syringes, and connecting tube. The specimen can be used for the detection of cancer, infection, or other bone disorders. The device may also be used for vertebral infusion (e.g., injection of bone cement). This is a single-use device.","implantable":false,"gmdnCodeStatus":"Active"}]},"productCodes":{"fdaProductCode":[{"productCode":"GDF","productCodeName":"Guide, Needle, Surgical"}]},"deviceSizes":{"deviceSize":[]},"environmentalConditions":{"storageHandling":[]},"sterilization":{"deviceSterile":true,"sterilizationPriorToUse":false,"methodTypes":{"sterilizationMethod":[]}},"xmlns":"http://www.fda.gov/cdrh/gudid","xsi":"http://www.w3.org/2001/XMLSchema-instance","anomaly":null,"premarketSubmissions":{"premarketSubmission":[]}}