{"publicDeviceRecordKey":"8a9bf77d-63e3-4f7e-9f80-9e1bf52f4f30","publicVersionStatus":"New","deviceRecordStatus":"Published","publicVersionNumber":1,"publicVersionDate":"2024-03-18T00:00:00.000Z","devicePublishDate":"2024-03-08T00:00:00.000Z","deviceCommDistributionEndDate":null,"deviceCommDistributionStatus":"In Commercial Distribution","identifiers":{"identifier":[{"deviceId":"00763000757779","deviceIdType":"Primary","deviceIdIssuingAgency":"GS1","containsDINumber":null,"pkgQuantity":null,"pkgDiscontinueDate":null,"pkgStatus":null,"pkgType":null}]},"brandName":"NanoCross™ Elite","versionModelNumber":"AB14W035080090","catalogNumber":null,"dunsNumber":"006261481","companyName":"MEDTRONIC, INC.","deviceCount":1,"deviceDescription":"PTA AB14W035080090 NANOCROSS 014 V06","DMExempt":false,"premarketExempt":false,"deviceHCTP":false,"deviceKit":false,"deviceCombinationProduct":false,"singleUse":true,"lotBatch":true,"serialNumber":false,"manufacturingDate":false,"expirationDate":false,"donationIdNumber":false,"labeledContainsNRL":false,"labeledNoNRL":false,"MRISafetyStatus":"Labeling does not contain MRI Safety Information","rx":true,"otc":false,"contacts":{"customerContact":[{"phone":"+1(800)633-8766","phoneExtension":null,"email":"Corporate.UDI@medtronic.com"}]},"premarketSubmissions":{"premarketSubmission":[{"submissionNumber":"K141118","supplementNumber":"000"}]},"gmdnTerms":{"gmdn":[{"gmdnCode":"17184","gmdnPTName":"Peripheral angioplasty balloon catheter, basic","gmdnPTDefinition":"A sterile, non-drug-eluting, flexible tube designed for percutaneous transluminal angioplasty (PTA) to dilate a stenotic peripheral (i.e., non-cerebral, non-coronary) artery by controlled inflation of a distensible balloon(s) at its distal tip; it may also be intended for positioning and expansion of a stent/stent-graft. It is available as an over-the-wire (OTW) type with multiple lumens, or a rapid exchange (RX) type with a single lumen. Some types may include cutting/scoring elements (e.g., microsurgical blades, dual wire configurations) to score/modify the plaque. This is a single-use device.","implantable":false,"gmdnCodeStatus":"Active"}]},"productCodes":{"fdaProductCode":[{"productCode":"LIT","productCodeName":"Catheter, angioplasty, peripheral, transluminal"}]},"deviceSizes":{"deviceSize":[{"sizeType":"Balloon Diameter","size":{"unit":"Millimeter","value":"3.5"},"sizeText":null,"sizeString":"Balloon Diameter: 3.5 Millimeter"},{"sizeType":"Catheter Working Length","size":{"unit":"Centimeter","value":"90.0"},"sizeText":null,"sizeString":"Catheter Working Length: 90.0 Centimeter"},{"sizeType":"Balloon Length","size":{"unit":"Millimeter","value":"80.0"},"sizeText":null,"sizeString":"Balloon Length: 80.0 Millimeter"},{"sizeType":"Device Size Text, specify","size":{"unit":"","value":""},"sizeText":"Minimum sheath inner diameter 4 Fr"}]},"environmentalConditions":{"storageHandling":[{"storageHandlingType":"Special Storage Condition, Specify","storageHandlingHigh":{"unit":"","value":""},"storageHandlingLow":{"unit":"","value":""},"storageHandlingSpecialConditionText":"Keep away from sunlight"},{"storageHandlingType":"Special Storage Condition, Specify","storageHandlingHigh":{"unit":"","value":""},"storageHandlingLow":{"unit":"","value":""},"storageHandlingSpecialConditionText":"Keep dry"}]},"sterilization":{"deviceSterile":true,"sterilizationPriorToUse":false,"methodTypes":{"sterilizationMethod":[]}},"xmlns":"http://www.fda.gov/cdrh/gudid","xsi":"http://www.w3.org/2001/XMLSchema-instance","anomaly":null}