{"publicDeviceRecordKey":"7b6327b0-c122-4b1a-b8f6-4f81c55c9cdc","publicVersionStatus":"Update","deviceRecordStatus":"Published","publicVersionNumber":6,"publicVersionDate":"2024-09-24T00:00:00.000Z","devicePublishDate":"2015-07-01T00:00:00.000Z","deviceCommDistributionEndDate":null,"deviceCommDistributionStatus":"In Commercial Distribution","identifiers":{"identifier":[{"deviceId":"10859389005147","deviceIdType":"Package","deviceIdIssuingAgency":"GS1","containsDINumber":"00859389005140","pkgQuantity":5,"pkgDiscontinueDate":null,"pkgStatus":"In Commercial Distribution","pkgType":"Box"},{"deviceId":"00859389005140","deviceIdType":"Primary","deviceIdIssuingAgency":"GS1","containsDINumber":null,"pkgQuantity":null,"pkgDiscontinueDate":null,"pkgStatus":null,"pkgType":null}]},"brandName":"VasCure for Vascular Repair","versionModelNumber":"CMCV-013-609","catalogNumber":null,"dunsNumber":"080924060","companyName":"Elutia Med LLC","deviceCount":1,"deviceDescription":"VasCure for Vascular Repair is intended for use as a patch material for repair and reconstruction of peripheral vasculature including the carotid, renal, iliac, femoral, and tibial blood vessels. VasCure for Vascular Repair may be used for patch closure of vessels, as a pledget, or for suture line buttressing when repairing peripheral vessels.","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":"MR Safe","rx":true,"otc":false,"contacts":{"customerContact":[{"phone":"470-514-4080","phoneExtension":null,"email":"xxx@xx.xx"}]},"premarketSubmissions":{"premarketSubmission":[{"submissionNumber":"K140789","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":"Height","size":{"unit":"Centimeter","value":"1"},"sizeText":null,"sizeString":"Height: 1 Centimeter"},{"sizeType":"Width","size":{"unit":"Centimeter","value":"10"},"sizeText":null,"sizeString":"Width: 10 Centimeter"}]},"environmentalConditions":{"storageHandling":[{"storageHandlingType":"Storage Environment Temperature","storageHandlingHigh":{"unit":"Degrees Celsius","value":"30"},"storageHandlingLow":{"unit":"Degrees Celsius","value":"10"},"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}