{"publicDeviceRecordKey":"90d39f8a-ed50-418c-8fcc-878f03e588e9","publicVersionStatus":"New","deviceRecordStatus":"Published","publicVersionNumber":1,"publicVersionDate":"2024-07-08T00:00:00.000Z","devicePublishDate":"2024-06-28T00:00:00.000Z","deviceCommDistributionEndDate":null,"deviceCommDistributionStatus":"In Commercial Distribution","identifiers":{"identifier":[{"deviceId":"04049197190824","deviceIdType":"Primary","deviceIdIssuingAgency":"GS1","containsDINumber":null,"pkgQuantity":null,"pkgDiscontinueDate":null,"pkgStatus":null,"pkgType":null}]},"brandName":"RZ Medizintechnik GmbH","versionModelNumber":"260-002-203","catalogNumber":"260-002-203","dunsNumber":"312953227","companyName":"RZ-Medizintechnik GmbH","deviceCount":1,"deviceDescription":"SHAPER Endoforehead Elevator            \nstraight, 7 mm wide, 240mm, 9 1/2''     \nwith Ergo Handle, malleable","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":true,"MRISafetyStatus":"Labeling does not contain MRI Safety Information","rx":true,"otc":false,"contacts":{"customerContact":[{"phone":"+49746294700","phoneExtension":null,"email":"info@rz-medizintechnik.com"}]},"gmdnTerms":{"gmdn":[{"gmdnCode":"35048","gmdnPTName":"Bone lever/elevator, reusable","gmdnPTDefinition":"A manual surgical instrument designed to lift, position, or pry up (elevate) bone, other anatomical structures, or surgical material/devices during an orthopaedic intervention. It is made of high-grade stainless steel and is available in a wide variety of sizes, designs, and blade shapes. It is typically a robust instrument with a blunted blade with no cutting edge at the distal end that can be pointed, rounded, flat, curved or hook shaped and a handle of various designs at the proximal end. Some types can have special functions, e.g., for angle joint operations or for luxation procedures. This is a reusable device.","implantable":false,"gmdnCodeStatus":"Active"}]},"productCodes":{"fdaProductCode":[{"productCode":"GEG","productCodeName":"ELEVATOR, SURGICAL, GENERAL \u0026 PLASTIC SURGERY"}]},"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":[]}}