{"publicDeviceRecordKey":"ab3c1e64-4d70-4cc7-9319-416438b627f1","publicVersionStatus":"Update","deviceRecordStatus":"Published","publicVersionNumber":2,"publicVersionDate":"2021-02-05T00:00:00.000Z","devicePublishDate":"2020-07-16T00:00:00.000Z","deviceCommDistributionEndDate":null,"deviceCommDistributionStatus":"In Commercial Distribution","identifiers":{"identifier":[{"deviceId":"05037881010663","deviceIdType":"Primary","deviceIdIssuingAgency":"GS1","containsDINumber":null,"pkgQuantity":null,"pkgDiscontinueDate":null,"pkgStatus":null,"pkgType":null}]},"brandName":"Gelsoft™ Cardiovascular Patch","versionModelNumber":"961001S","catalogNumber":"961001S","dunsNumber":"229053087","companyName":"VASCUTEK LTD","deviceCount":1,"deviceDescription":"Gelsoft Gelatin Impregnated Knitted Cardiovascular Patch","DMExempt":false,"premarketExempt":false,"deviceHCTP":false,"deviceKit":false,"deviceCombinationProduct":false,"singleUse":true,"lotBatch":true,"serialNumber":true,"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":"+1(800)888-3786","phoneExtension":null,"email":"tmccustomer.admin@terumomedical.com"}]},"premarketSubmissions":{"premarketSubmission":[{"submissionNumber":"K200955","supplementNumber":"000"},{"submissionNumber":"K963611","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":"DXZ","productCodeName":"PATCH, PLEDGET AND INTRACARDIAC, PETP, PTFE, POLYPROPYLENE"}]},"deviceSizes":{"deviceSize":[{"sizeType":"Device Size Text, specify","size":{"unit":"","value":""},"sizeText":"Dimensions 10 x 1 cm"}]},"environmentalConditions":{"storageHandling":[{"storageHandlingType":"Special Storage Condition, Specify","storageHandlingHigh":{"unit":"","value":""},"storageHandlingLow":{"unit":"","value":""},"storageHandlingSpecialConditionText":"Store in clean, dry area at room temperature. Vascutek Ltd Sealed Patches must be\nimplanted within one month after removal from\nthe foil pouch."}]},"sterilization":{"deviceSterile":true,"sterilizationPriorToUse":false,"methodTypes":{"sterilizationMethod":[]}},"xmlns":"http://www.fda.gov/cdrh/gudid","xsi":"http://www.w3.org/2001/XMLSchema-instance","anomaly":null}