{"publicDeviceRecordKey":"551a0a48-2dc2-49e6-a081-0d1af9808808","publicVersionStatus":"New","deviceRecordStatus":"Published","publicVersionNumber":1,"publicVersionDate":"2020-10-05T00:00:00.000Z","devicePublishDate":"2020-09-25T00:00:00.000Z","deviceCommDistributionEndDate":null,"deviceCommDistributionStatus":"In Commercial Distribution","identifiers":{"identifier":[{"deviceId":"04046826119430","deviceIdType":"Primary","deviceIdIssuingAgency":"GS1","containsDINumber":null,"pkgQuantity":null,"pkgDiscontinueDate":null,"pkgStatus":null,"pkgType":null}]},"brandName":"Medicon","versionModelNumber":"68.25.89","catalogNumber":"68.25.89","dunsNumber":"315492330","companyName":"Medicon eG. Chirurgiemechaniker-Genossenschaft","deviceCount":1,"deviceDescription":"Steinhäuser bone hold fcps 16.5cm","DMExempt":true,"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":true,"otc":false,"contacts":{"customerContact":[{"phone":"+490746220090","phoneExtension":null,"email":"sales@medicon.de"}]},"gmdnTerms":{"gmdn":[{"gmdnCode":"34949","gmdnPTName":"Bone approximation clamp","gmdnPTDefinition":"A hand-held manual surgical instrument designed to grip and hold a bone or, being used in pairs one on either side of the fracture, to approximate the proximal and distal segment of a fractured bone during orthopaedic surgery. It is typically made of high-grade stainless steel and is designed with a double hooked, blade-like jaw at the distal end (this hooks over the upper edge of the bone) whilst an adjustable single hook is tightened against the lower edge of the bone through a screw mechanism. A traction bar may be employed to bridge the two bone clamps and using its screw mechanism, the fracture is drawn together. This is a reusable device.","implantable":false,"gmdnCodeStatus":"Active"}]},"productCodes":{"fdaProductCode":[{"productCode":"GDJ","productCodeName":"CLAMP, 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":[]}}