{"publicDeviceRecordKey":"6f1e560c-3491-43e3-b480-7585416c51ea","publicVersionStatus":"Update","deviceRecordStatus":"Published","publicVersionNumber":4,"publicVersionDate":"2019-04-09T00:00:00.000Z","devicePublishDate":"2016-05-08T00:00:00.000Z","deviceCommDistributionEndDate":"2018-10-05T00:00:00.000Z","deviceCommDistributionStatus":"Not in Commercial Distribution","identifiers":{"identifier":[{"deviceId":"08033477034294","deviceIdType":"Primary","deviceIdIssuingAgency":"GS1","containsDINumber":null,"pkgQuantity":null,"pkgDiscontinueDate":null,"pkgStatus":null,"pkgType":null}]},"brandName":"FiberNet","versionModelNumber":"FBC500600190","catalogNumber":null,"dunsNumber":"006261481","companyName":"MEDTRONIC, INC.","deviceCount":1,"deviceDescription":"Cath FBC500600190 FBC SW 5.0-6.0 UL1900","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"}]},"gmdnTerms":{"gmdn":[{"gmdnCode":"44841","gmdnPTName":"Embolic protection filtering guidewire","gmdnPTDefinition":"A steerable wire with a filter at its distal end intended to be used to facilitate the placement of diagnostic/interventional vascular devices (e.g., angioplasty balloons, intravascular stents) in the lumen of a blood vessel (coronary, carotid, peripheral), and to provide embolic protection by capturing emboli that may result from the procedure. The filter is deployable (expandable) once inserted distal to the vascular lesion (e.g., atherosclerotic plaque). It typically includes devices for introduction/removal of the guidewire (e.g., deployment/removal sheath), which are not intended to be used as working channels for other interventional devices. This is a single-use device.","implantable":false,"gmdnCodeStatus":"Active"}]},"productCodes":{"fdaProductCode":[{"productCode":"NTE","productCodeName":"Temporary Carotid Catheter for Embolic Capture"}]},"deviceSizes":{"deviceSize":[{"sizeType":"Device Size Text, specify","size":{"unit":"","value":""},"sizeText":"5.0-6.0 MM Recommended Vessel Diameter"},{"sizeType":"Length","size":{"unit":"Centimeter","value":"190.0"},"sizeText":null,"sizeString":"Length: 190.0 Centimeter"}]},"environmentalConditions":{"storageHandling":[{"storageHandlingType":"Special Storage Condition, Specify","storageHandlingHigh":{"unit":"","value":""},"storageHandlingLow":{"unit":"","value":""},"storageHandlingSpecialConditionText":"Store at controlled room temperature, in a dry place.  Keep away from sunlight."}]},"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":[]}}