{"publicDeviceRecordKey":"b7a67080-94d0-4cb5-8e0e-fd5dd3eea09f","publicVersionStatus":"Update","deviceRecordStatus":"Published","publicVersionNumber":3,"publicVersionDate":"2021-01-22T00:00:00.000Z","devicePublishDate":"2019-01-23T00:00:00.000Z","deviceCommDistributionEndDate":null,"deviceCommDistributionStatus":"In Commercial Distribution","identifiers":{"identifier":[{"deviceId":"B504OMSP4100","deviceIdType":"Primary","deviceIdIssuingAgency":"HIBCC","containsDINumber":null,"pkgQuantity":null,"pkgDiscontinueDate":null,"pkgStatus":null,"pkgType":null}]},"brandName":"MicroAire","versionModelNumber":"SP-410","catalogNumber":null,"dunsNumber":"016889401","companyName":"Provision","deviceCount":1,"deviceDescription":null,"DMExempt":true,"premarketExempt":true,"deviceHCTP":false,"deviceKit":false,"deviceCombinationProduct":false,"singleUse":true,"lotBatch":true,"serialNumber":false,"manufacturingDate":true,"expirationDate":true,"donationIdNumber":false,"labeledContainsNRL":false,"labeledNoNRL":false,"MRISafetyStatus":"Labeling does not contain MRI Safety Information","rx":true,"otc":false,"contacts":{"customerContact":[{"phone":"541-480-7953","phoneExtension":null,"email":"customersupport@provisiondrs.com"}]},"gmdnTerms":{"gmdn":[{"gmdnCode":"63598","gmdnPTName":"Surgical saw blade, reciprocating, reprocessed","gmdnPTDefinition":"A flat surgical cutting instrument with a serrated edge, designed for attachment to a dedicated powered saw used for cutting bone/tissue during orthopaedic or oral surgery; it is not dedicated to cutting through the sternum (not a dedicated sternum saw blade). It is designed with the cutting teeth arranged in a straight line along the cutting edge and which cuts when the blade is powered in a rapid reciprocating movement (a back and forth motion like a jigsaw) against the object to be cut. The end of the blade is typically not protected. This is a single-use device that has previously been used on a patient and has been reprocessed for an additional single-use patient application.","implantable":false,"gmdnCodeStatus":"Active"}]},"productCodes":{"fdaProductCode":[{"productCode":"GFA","productCodeName":"Blade, Saw, General \u0026 Plastic Surgery, 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":[]}}