{"publicDeviceRecordKey":"75ae7598-0aeb-42ba-8aeb-b6caeef79dee","publicVersionStatus":"Update","deviceRecordStatus":"Published","publicVersionNumber":3,"publicVersionDate":"2022-08-17T00:00:00.000Z","devicePublishDate":"2019-12-11T00:00:00.000Z","deviceCommDistributionEndDate":null,"deviceCommDistributionStatus":"In Commercial Distribution","identifiers":{"identifier":[{"deviceId":"00840314214799","deviceIdType":"Primary","deviceIdIssuingAgency":"GS1","containsDINumber":null,"pkgQuantity":null,"pkgDiscontinueDate":null,"pkgStatus":null,"pkgType":null}]},"brandName":"gSource","versionModelNumber":"gS 36.6438","catalogNumber":"gS 36.6438","dunsNumber":"008162518","companyName":"GSOURCE LLC","deviceCount":1,"deviceDescription":"Caspar Nerve Root Retr 9 1/2\" 8mm malleable\n","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":false,"otc":false,"contacts":{"customerContact":[]},"gmdnTerms":{"gmdn":[{"gmdnCode":"46768","gmdnPTName":"Nerve/vessel retractor","gmdnPTDefinition":"A hand-held, non-self-retaining surgical instrument intended to be used for retracting a nerve, tendon, or blood vessel to separate it from the surrounding tissue primarily to allow access to other tissues during a surgical intervention. It is a shaft-like metallic instrument with a blunt bulbous or rounded hook-like retraction tip at the distal end, and a handle at the proximal end. It is available in a variety of designs such as, curved, right-angled, or 45 degree angled. This is a reusable device.","implantable":false,"gmdnCodeStatus":"Active"}]},"productCodes":{"fdaProductCode":[{"productCode":"GAD","productCodeName":"Retractor"}]},"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":[]}}