{"publicDeviceRecordKey":"ba04300e-f733-44d5-b744-e0b1930bc5d7","publicVersionStatus":"New","deviceRecordStatus":"Published","publicVersionNumber":1,"publicVersionDate":"2023-08-29T00:00:00.000Z","devicePublishDate":"2023-08-21T00:00:00.000Z","deviceCommDistributionEndDate":null,"deviceCommDistributionStatus":"In Commercial Distribution","identifiers":{"identifier":[{"deviceId":"26950900965160","deviceIdType":"Package","deviceIdIssuingAgency":"GS1","containsDINumber":"06950900965166","pkgQuantity":5,"pkgDiscontinueDate":null,"pkgStatus":"In Commercial Distribution","pkgType":" box"},{"deviceId":"06950900965166","deviceIdType":"Primary","deviceIdIssuingAgency":"GS1","containsDINumber":null,"pkgQuantity":null,"pkgDiscontinueDate":null,"pkgStatus":null,"pkgType":null},{"deviceId":"46950900965164","deviceIdType":"Package","deviceIdIssuingAgency":"GS1","containsDINumber":"06950900965166","pkgQuantity":25,"pkgDiscontinueDate":null,"pkgStatus":"In Commercial Distribution","pkgType":"carton"}]},"brandName":"INT,FineThrough","versionModelNumber":"NS1403200CS","catalogNumber":null,"dunsNumber":"420827639","companyName":"Shanghai Kindly Medical Instruments Co., Ltd.","deviceCount":1,"deviceDescription":null,"DMExempt":false,"premarketExempt":false,"deviceHCTP":false,"deviceKit":false,"deviceCombinationProduct":false,"singleUse":true,"lotBatch":true,"serialNumber":false,"manufacturingDate":true,"expirationDate":true,"donationIdNumber":false,"labeledContainsNRL":false,"labeledNoNRL":false,"MRISafetyStatus":"Labeling does not contain MRI Safety Information","rx":false,"otc":false,"contacts":{"customerContact":[]},"premarketSubmissions":{"premarketSubmission":[{"submissionNumber":"K180177","supplementNumber":"000"}]},"gmdnTerms":{"gmdn":[{"gmdnCode":"35094","gmdnPTName":"Cardiac/peripheral vascular guidewire, single-use","gmdnPTDefinition":"A long, thin, sterile wire intended to be percutaneously placed into the cardiac vasculature (ventricles or coronary vessels) to function as a guide for the introduction, positioning, and/or operation of a device (e.g., catheter, pacing lead); it may also be used in the peripheral vasculature. It may be made of metal (e.g., stainless steel, Nitinol), or polymer and/or glass materials to provide MRI-compatibility, with or without coating, and is available in a variety of distal tip designs. It is used for various diagnostic and interventional procedures, and may include devices used to facilitate manipulation (e.g., torque device). This is a single-use device.","implantable":false,"gmdnCodeStatus":"Active"}]},"productCodes":{"fdaProductCode":[{"productCode":"DQX","productCodeName":"Wire, Guide, Catheter"}]},"deviceSizes":{"deviceSize":[]},"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}