{"publicDeviceRecordKey":"58ec5de5-342d-4bf9-811d-0c35e0aaf0ab","publicVersionStatus":"Update","deviceRecordStatus":"Published","publicVersionNumber":3,"publicVersionDate":"2020-09-07T00:00:00.000Z","devicePublishDate":"2014-09-24T00:00:00.000Z","deviceCommDistributionEndDate":null,"deviceCommDistributionStatus":"In Commercial Distribution","identifiers":{"identifier":[{"deviceId":"M68120104000000","deviceIdType":"Primary","deviceIdIssuingAgency":"HIBCC","containsDINumber":null,"pkgQuantity":null,"pkgDiscontinueDate":null,"pkgStatus":null,"pkgType":null}]},"brandName":"Apelo®  / Apelo® MIS","versionModelNumber":"2010-40-0000","catalogNumber":"2010-40-0000","dunsNumber":"140801007","companyName":"ATLAS SPINE, INC.","deviceCount":1,"deviceDescription":"MIS Sleeve Assembly, Cannulated Screwdriver","DMExempt":false,"premarketExempt":true,"deviceHCTP":false,"deviceKit":false,"deviceCombinationProduct":false,"singleUse":false,"lotBatch":false,"serialNumber":true,"manufacturingDate":true,"expirationDate":false,"donationIdNumber":false,"labeledContainsNRL":false,"labeledNoNRL":false,"MRISafetyStatus":"MR Conditional","rx":true,"otc":false,"contacts":{"customerContact":[{"phone":"(561) 741-1108","phoneExtension":null,"email":"sales@atlasspine.com"}]},"gmdnTerms":{"gmdn":[{"gmdnCode":"47831","gmdnPTName":"Orthopaedic implantation sleeve, reusable","gmdnPTDefinition":"A hand-held tubular surgical device designed to be used during an orthopaedic implantation procedure to hold/grip an implant (e.g., an orthopaedic bone screw), facilitate the acceptance of an orthopaedic instrument (e.g., a screwdriver or a smaller diameter sleeve) through it, stabilize an instrument/implant coupling, and/or protect the surgeon's gloved hand or patient tissue. It is not primarily intended to place, angle, and guide a rotating surgical drill. It is typically made of high-grade stainless steel and/or synthetic materials and is available in various sizes and lengths. This is a reusable device.","implantable":false,"gmdnCodeStatus":"Active"}]},"productCodes":{"fdaProductCode":[{"productCode":"HXX","productCodeName":"Screwdriver"}]},"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":[]}}