{"publicDeviceRecordKey":"0bfdfc18-fadf-4539-84df-a524841cac53","publicVersionStatus":"Update","deviceRecordStatus":"Published","publicVersionNumber":5,"publicVersionDate":"2023-09-04T00:00:00.000Z","devicePublishDate":"2016-09-12T00:00:00.000Z","deviceCommDistributionEndDate":null,"deviceCommDistributionStatus":"In Commercial Distribution","identifiers":{"identifier":[{"deviceId":"B39034191","deviceIdType":"Primary","deviceIdIssuingAgency":"HIBCC","containsDINumber":null,"pkgQuantity":null,"pkgDiscontinueDate":null,"pkgStatus":null,"pkgType":null}]},"brandName":"Reprocessed 2.9mm Full Radius Blade","versionModelNumber":"3419","catalogNumber":null,"dunsNumber":"785616934","companyName":"SURETEK MEDICAL","deviceCount":1,"deviceDescription":null,"DMExempt":false,"premarketExempt":true,"deviceHCTP":false,"deviceKit":false,"deviceCombinationProduct":false,"singleUse":true,"lotBatch":true,"serialNumber":false,"manufacturingDate":false,"expirationDate":true,"donationIdNumber":false,"labeledContainsNRL":false,"labeledNoNRL":false,"MRISafetyStatus":"Labeling does not contain MRI Safety Information","rx":true,"otc":false,"contacts":{"customerContact":[]},"gmdnTerms":{"gmdn":[{"gmdnCode":"61800","gmdnPTName":"Arthroscopic shaver system blade, reprocessed","gmdnPTDefinition":"A cutting device designed for use in a powered arthroscopic shaver system handpiece (not included) for bone and soft-tissue resection during arthroscopic surgery on a joint (e.g., a knee, shoulder, or ankle). It is locked into the handpiece, and typically consists of a small outer tube with a hub and a rotating inner tube with a connector that performs a rotational or reciprocating (back and forth) motion. It is typically made of high-grade stainless steel. This is a previously used single-use device that has been processed for an additional single-use patient application.","implantable":false,"gmdnCodeStatus":"Active"}]},"productCodes":{"fdaProductCode":[{"productCode":"NBH","productCodeName":"Accessories, Arthroscopic"}]},"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":[]}}