{"publicDeviceRecordKey":"4db390a3-5cf8-4e84-a1b3-05765ebf3071","publicVersionStatus":"New","deviceRecordStatus":"Published","publicVersionNumber":1,"publicVersionDate":"2023-09-12T00:00:00.000Z","devicePublishDate":"2023-09-04T00:00:00.000Z","deviceCommDistributionEndDate":null,"deviceCommDistributionStatus":"In Commercial Distribution","identifiers":{"identifier":[{"deviceId":"08033860004255","deviceIdType":"Primary","deviceIdIssuingAgency":"GS1","containsDINumber":null,"pkgQuantity":null,"pkgDiscontinueDate":null,"pkgStatus":null,"pkgType":null}]},"brandName":"Biopsybell","versionModelNumber":"SPEEDYBELL","catalogNumber":"SB1510EC","dunsNumber":"438746708","companyName":"BIOPSYBELL SRL","deviceCount":1,"deviceDescription":"Semiautomatic guillotine needle for soft-tissue biopsy","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":"K130616","supplementNumber":"000"}]},"gmdnTerms":{"gmdn":[{"gmdnCode":"22726","gmdnPTName":"End-cut biopsy gun handpiece/needle","gmdnPTDefinition":"A hand-operated, non-electronic, surgical instrument designed for the automatic extraction of a core tissue sample from an anatomical structure (a biopsy), while causing minimal surrounding tissue damage, for tissue pathological examination/testing. It consists of both: 1) a handpiece with a spring-loaded mechanism and release trigger; and 2) a percutaneous, open, cylindrical biopsy needle that allows a full-width tissue sample to be obtained over the entire length of the biopsy when activated. It is typically used to obtain samples of soft tissue from the kidneys, prostate, pancreas, liver, and breast, often performed under image guidance. This is a single-use device.","implantable":false,"gmdnCodeStatus":"Active"}]},"productCodes":{"fdaProductCode":[{"productCode":"FCG","productCodeName":"Biopsy Needle"},{"productCode":"KNW","productCodeName":"Instrument, Biopsy"}]},"deviceSizes":{"deviceSize":[{"sizeType":"Length","size":{"unit":"Millimeter","value":"100"},"sizeText":null,"sizeString":"Length: 100 Millimeter"},{"sizeType":"Needle Gauge","size":{"unit":"Gauge","value":"15"},"sizeText":null,"sizeString":"Needle Gauge: 15 Gauge"}]},"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}