{"publicDeviceRecordKey":"b0f42e10-c15d-4ebf-b718-f26bbe329247","publicVersionStatus":"Update","deviceRecordStatus":"Published","publicVersionNumber":4,"publicVersionDate":"2023-12-08T00:00:00.000Z","devicePublishDate":"2022-07-11T00:00:00.000Z","deviceCommDistributionEndDate":"2023-11-01T00:00:00.000Z","deviceCommDistributionStatus":"Not in Commercial Distribution","identifiers":{"identifier":[{"deviceId":"00685447012467","deviceIdType":"Primary","deviceIdIssuingAgency":"GS1","containsDINumber":null,"pkgQuantity":null,"pkgDiscontinueDate":null,"pkgStatus":null,"pkgType":null}]},"brandName":"VersaCross Large Access Solution","versionModelNumber":"VLAK0007","catalogNumber":"NA","dunsNumber":"249225954","companyName":"Baylis Médicale Cie Inc","deviceCount":1,"deviceDescription":"1 x VersaCross Large Access Transseptal Dilator (including 1 x J-tip Mechanical Guidewire); 1 x VersaCross RF Wire (including 1 x Connector Cable (Single Use))","DMExempt":false,"premarketExempt":false,"deviceHCTP":false,"deviceKit":true,"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":"5144889801","phoneExtension":null,"email":"info@baylismedical.com"}]},"gmdnTerms":{"gmdn":[{"gmdnCode":"47247","gmdnPTName":"Cardiac transseptal access set","gmdnPTDefinition":"A collection of nonimplantable, invasive devices intended to be used to puncture the interatrial septum during a transseptal catheterization procedure, and to create a conduit for the introduction of various cardiovascular catheters into the left side of the heart. It includes a vascular guide-catheter (which may be referred to as a steerable introducer) with a transseptal needle to create the puncture, and typically includes additional introduction assistive devices necessary for the procedure (e.g., stylet, guidewire, dilator). This is a single-use device.","implantable":false,"gmdnCodeStatus":"Active"}]},"productCodes":{"fdaProductCode":[{"productCode":"DXF","productCodeName":"Catheter, Septostomy"},{"productCode":"DRE","productCodeName":"Dilator, Vessel, For Percutaneous Catheterization"}]},"deviceSizes":{"deviceSize":[{"sizeType":"Device Size Text, specify","size":{"unit":"","value":""},"sizeText":"12.5F 85cm VersaCross Large Access Transseptal Dilator with standard curve D0 (180cm J-Tip Mechanical Guidewire OD=0.035in (0.89mm)); 230cm J-Tip VersaCross RF Wire OD=0.035in/10ft/3m Connector Cable"}]},"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,"premarketSubmissions":{"premarketSubmission":[]}}