{"publicDeviceRecordKey":"db415542-ed1a-4062-b42e-da66d130c6e9","publicVersionStatus":"Update","deviceRecordStatus":"Published","publicVersionNumber":4,"publicVersionDate":"2020-06-19T00:00:00.000Z","devicePublishDate":"2017-02-12T00:00:00.000Z","deviceCommDistributionEndDate":null,"deviceCommDistributionStatus":"In Commercial Distribution","identifiers":{"identifier":[{"deviceId":"M958BPY0010","deviceIdType":"Primary","deviceIdIssuingAgency":"HIBCC","containsDINumber":null,"pkgQuantity":null,"pkgDiscontinueDate":null,"pkgStatus":null,"pkgType":null}]},"brandName":"BioSphere Putty","versionModelNumber":"1cc","catalogNumber":"BPY-001","dunsNumber":"078270195","companyName":"SYNERGY BIOMEDICAL, LLC","deviceCount":1,"deviceDescription":null,"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":false,"MRISafetyStatus":"Labeling does not contain MRI Safety Information","rx":true,"otc":false,"contacts":{"customerContact":[{"phone":"484-902-8141","phoneExtension":null,"email":"info@synergybiomedical.com"}]},"premarketSubmissions":{"premarketSubmission":[{"submissionNumber":"K140844","supplementNumber":"000"}]},"gmdnTerms":{"gmdn":[{"gmdnCode":"17751","gmdnPTName":"Bone matrix implant, synthetic, non-antimicrobial","gmdnPTDefinition":"A bioabsorbable device made of synthetic material intended to be implanted into the body to provide osteoconductive bone-tissue scaffolds, and sometimes osteovascularization, to replace bone lost through trauma, surgery, or pathological conditions (e.g., osteoporosis); it does not include an antimicrobial agent(s). It may be made of ceramics (e.g., tricalcium phosphate or hydroxyapatite), bioactive glasses/minerals/metals (e.g., strontium), or bioabsorbable polymers. It is used to fill cystic defects, repair fractures, and/or extend autogenous bone grafts and is typically provided as cancellous blocks, chips, or granules of varying sizes, or mouldable/fluid materials.","implantable":true,"gmdnCodeStatus":"Active"}]},"productCodes":{"fdaProductCode":[{"productCode":"MQV","productCodeName":"Filler, Bone Void, Calcium Compound"}]},"deviceSizes":{"deviceSize":[{"sizeType":"Total Volume","size":{"unit":"Milliliter","value":"1"},"sizeText":null,"sizeString":"Total Volume: 1 Milliliter"}]},"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}