{"publicDeviceRecordKey":"8525dfb8-ca57-4f86-9c89-1eef8c54be73","publicVersionStatus":"New","deviceRecordStatus":"Published","publicVersionNumber":2,"publicVersionDate":"2018-07-06T00:00:00.000Z","devicePublishDate":"2018-06-01T00:00:00.000Z","deviceCommDistributionEndDate":"2018-06-01T00:00:00.000Z","deviceCommDistributionStatus":"Not in Commercial Distribution","identifiers":{"identifier":[{"deviceId":"00817580021925","deviceIdType":"Primary","deviceIdIssuingAgency":"GS1","containsDINumber":null,"pkgQuantity":null,"pkgDiscontinueDate":null,"pkgStatus":null,"pkgType":null}]},"brandName":"Kelyniam CSI ","versionModelNumber":"PEEK-IM1002","catalogNumber":"PEEK-IM1002","dunsNumber":"785088829","companyName":"KELYNIAM GLOBAL, INC.","deviceCount":1,"deviceDescription":"PEEK Customized Cranial Implant, Medium","DMExempt":false,"premarketExempt":false,"deviceHCTP":false,"deviceKit":false,"deviceCombinationProduct":false,"singleUse":true,"lotBatch":true,"serialNumber":true,"manufacturingDate":true,"expirationDate":true,"donationIdNumber":true,"labeledContainsNRL":false,"labeledNoNRL":true,"MRISafetyStatus":"MR Safe","rx":true,"otc":false,"contacts":{"customerContact":[]},"premarketSubmissions":{"premarketSubmission":[{"submissionNumber":"K103582","supplementNumber":"000"}]},"gmdnTerms":{"gmdn":[{"gmdnCode":"46268","gmdnPTName":"Cranioplasty plate, non-alterable","gmdnPTDefinition":"An implantable shield designed to repair larger skull defects that is preformed before surgery and typically made of sheets of material [e.g., stainless steel, vitallium, titanium (Ti), plastic resins] that cannot be reshaped at the time of surgery without changing the physical or chemical properties of the material. The device is generally preformed with a central convex curvature matching the curvature of the forehead, side, or rear areas of the human adult skull; it is usually fixed to the intact cranial bones using screws and/or other fasteners. The device is used to repair defects due to injury, surgical intervention for tumour removal, congenital anomaly, or disease.","implantable":true,"gmdnCodeStatus":"Active"}]},"productCodes":{"fdaProductCode":[{"productCode":"GXN","productCodeName":"Plate, Cranioplasty, Preformed, Non-Alterable"}]},"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}