{"publicDeviceRecordKey":"e1c922ee-fd38-423a-a241-d52c7ed1df37","publicVersionStatus":"Update","deviceRecordStatus":"Published","publicVersionNumber":2,"publicVersionDate":"2025-01-21T00:00:00.000Z","devicePublishDate":"2024-01-11T00:00:00.000Z","deviceCommDistributionEndDate":null,"deviceCommDistributionStatus":"In Commercial Distribution","identifiers":{"identifier":[{"deviceId":"08033860023980","deviceIdType":"Primary","deviceIdIssuingAgency":"GS1","containsDINumber":null,"pkgQuantity":null,"pkgDiscontinueDate":null,"pkgStatus":null,"pkgType":null}]},"brandName":"BIOPSYBELL","versionModelNumber":"RENOVA SPINE BALLOON CATHETER","catalogNumber":"RESB15J","dunsNumber":"438746708","companyName":"BIOPSYBELL SRL","deviceCount":1,"deviceDescription":"REDUCTION AND FIXATION OF FRACTURES AND/OR CREATION OF A VOID IN CANCELLOUS BONE IN THE SPINE DURING BALLOON KYPHOPLASTY (FOR USE WITH CLEARED SPINAL POLYMETHYLMETHACRYLATE (PMMA) BONE CEMENTS)","DMExempt":false,"premarketExempt":false,"deviceHCTP":false,"deviceKit":false,"deviceCombinationProduct":false,"singleUse":true,"lotBatch":true,"serialNumber":false,"manufacturingDate":false,"expirationDate":true,"donationIdNumber":false,"labeledContainsNRL":false,"labeledNoNRL":true,"MRISafetyStatus":"Labeling does not contain MRI Safety Information","rx":true,"otc":false,"contacts":{"customerContact":[{"phone":"+39053527850","phoneExtension":null,"email":"support@biopsybell.it"}]},"premarketSubmissions":{"premarketSubmission":[{"submissionNumber":"K231340","supplementNumber":"000"}]},"gmdnTerms":{"gmdn":[{"gmdnCode":"58020","gmdnPTName":"Kyphoplasty balloon catheter","gmdnPTDefinition":"A sterile, flexible tube designed to be used for the creation of a void within a vertebral body during a minimally invasive procedure commonly known as balloon kyphoplasty. It is manually inserted percutaneously through an access channel under fluoroscopic guidance to a vertebral compression fracture (VCF) site (e.g., in the lumbar or thoracic region of the spine) where its balloon is inflated with a medium (e.g., a liquid contrast medium) to force the vertebrae apart for insertion of bone cement; thereafter it is deflated and removed via the access channel. This is a single-use device.","implantable":false,"gmdnCodeStatus":"Active"}]},"productCodes":{"fdaProductCode":[{"productCode":"HRX","productCodeName":"Arthroscope"},{"productCode":"NDN","productCodeName":"Cement, Bone, Vertebroplasty"}]},"deviceSizes":{"deviceSize":[{"sizeType":"Needle Gauge","size":{"unit":"Gauge","value":"11"},"sizeText":null,"sizeString":"Needle Gauge: 11 Gauge"},{"sizeType":"Balloon Length","size":{"unit":"Millimeter","value":"15"},"sizeText":null,"sizeString":"Balloon Length: 15 Millimeter"}]},"environmentalConditions":{"storageHandling":[]},"sterilization":{"deviceSterile":true,"sterilizationPriorToUse":false,"methodTypes":{"sterilizationMethod":[]}},"xmlns":"http://www.fda.gov/cdrh/gudid","xsi":"http://www.w3.org/2001/XMLSchema-instance","anomaly":null}