{"publicDeviceRecordKey":"a6a92888-642e-488e-b8d7-4ca5902fd135","publicVersionStatus":"Update","deviceRecordStatus":"Published","publicVersionNumber":2,"publicVersionDate":"2021-02-05T00:00:00.000Z","devicePublishDate":"2018-09-07T00:00:00.000Z","deviceCommDistributionEndDate":null,"deviceCommDistributionStatus":"In Commercial Distribution","identifiers":{"identifier":[{"deviceId":"09348992000334","deviceIdType":"Primary","deviceIdIssuingAgency":"GS1","containsDINumber":null,"pkgQuantity":null,"pkgDiscontinueDate":null,"pkgStatus":null,"pkgType":null}]},"brandName":"CardioCel 3D","versionModelNumber":"UC0405A30","catalogNumber":"C0405A30","dunsNumber":"741172167","companyName":"ADMEDUS REGEN PTY LTD","deviceCount":1,"deviceDescription":"CardioCel® 3D is prepared from bovine pericardium using the ADAPT® Tissue Processing Technology.\nThe pericardium is procured from cattle originating in Australia. Australia is considered as being of negligible risk\nfor BSE.\nThe device is a sterile, off-white, moist, pre-cut, flat or curved sheet of acellular collagen, presented sterile in a\nsolution of propylene glycol and sealed in a container impermeable to air and moisture.\n","DMExempt":false,"premarketExempt":false,"deviceHCTP":false,"deviceKit":false,"deviceCombinationProduct":false,"singleUse":true,"lotBatch":true,"serialNumber":false,"manufacturingDate":true,"expirationDate":true,"donationIdNumber":true,"labeledContainsNRL":false,"labeledNoNRL":false,"MRISafetyStatus":"Labeling does not contain MRI Safety Information","rx":true,"otc":false,"contacts":{"customerContact":[{"phone":"+61892660100","phoneExtension":null,"email":"info@admedus.com"}]},"premarketSubmissions":{"premarketSubmission":[{"submissionNumber":"K170951","supplementNumber":"000"}]},"gmdnTerms":{"gmdn":[{"gmdnCode":"35273","gmdnPTName":"Cardiovascular patch, animal-derived","gmdnPTDefinition":"An implantable material designed to reinforce suture lines and/or increase the strength of weak or injured cardiac and/or peripheral vascular tissues during cardiovascular repair/reconstruction procedures (e.g., annulus or septal defect repair, endarterectomy, profundaplasty). It is a patch made of, or coated/impregnated with, materials of animal origin (e.g., porcine, bovine, or equine pericardium/collagen), that is typically implanted with sutures.","implantable":true,"gmdnCodeStatus":"Active"}]},"productCodes":{"fdaProductCode":[{"productCode":"PSQ","productCodeName":"Intracardiac Patch Or Pledget, Biologically Derived"}]},"deviceSizes":{"deviceSize":[{"sizeType":"Width","size":{"unit":"Centimeter","value":"4"},"sizeText":null,"sizeString":"Width: 4 Centimeter"},{"sizeType":"Length","size":{"unit":"Centimeter","value":"5"},"sizeText":null,"sizeString":"Length: 5 Centimeter"},{"sizeType":"Angle","size":{"unit":"degree","value":"30"},"sizeText":null,"sizeString":"Angle: 30 degree"}]},"environmentalConditions":{"storageHandling":[{"storageHandlingType":"Handling Environment Temperature","storageHandlingHigh":{"unit":"Degrees Celsius","value":"25"},"storageHandlingLow":{"unit":"Degrees Celsius","value":"2"},"storageHandlingSpecialConditionText":null}]},"sterilization":{"deviceSterile":true,"sterilizationPriorToUse":false,"methodTypes":{"sterilizationMethod":[]}},"xmlns":"http://www.fda.gov/cdrh/gudid","xsi":"http://www.w3.org/2001/XMLSchema-instance","anomaly":null}