{"publicDeviceRecordKey":"9a826336-f333-42b8-a279-7e4d5c3bee3e","publicVersionStatus":"New","deviceRecordStatus":"Published","publicVersionNumber":1,"publicVersionDate":"2025-01-20T00:00:00.000Z","devicePublishDate":"2025-01-10T00:00:00.000Z","deviceCommDistributionEndDate":null,"deviceCommDistributionStatus":"In Commercial Distribution","identifiers":{"identifier":[{"deviceId":"15060238201848","deviceIdType":"Primary","deviceIdIssuingAgency":"GS1","containsDINumber":null,"pkgQuantity":null,"pkgDiscontinueDate":null,"pkgStatus":null,"pkgType":null}]},"brandName":"Bone Cement  Delivery Gun","versionModelNumber":"H719","catalogNumber":"H719","dunsNumber":"221751311","companyName":"SUMMIT MEDICAL LIMITED","deviceCount":1,"deviceDescription":"Bone Cement  Delivery Gun\n","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":"Labeling does not contain MRI Safety Information","rx":true,"otc":false,"contacts":{"customerContact":[{"phone":"+441451821311","phoneExtension":null,"email":"info@summit-medical.co.uk"}]},"gmdnTerms":{"gmdn":[{"gmdnCode":"47703","gmdnPTName":"Orthopaedic cement/bone filler dispensing gun","gmdnPTDefinition":"A hand-operated device designed to hold an orthopaedic cement/filler syringe/cartridge and to facilitate the dispensing of the substance to the application site or an application device. It is a pistol-like device with a barrel recess, to place the syringe/cartridge, which includes a trigger mechanism to force the substance from the distal end, and may include graduated markings to dispense the substance in discrete quantities. This is a reusable device.","implantable":false,"gmdnCodeStatus":"Active"}]},"productCodes":{"fdaProductCode":[{"productCode":"LXH","productCodeName":"Orthopedic Manual Surgical Instrument"}]},"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":[]}}