{"publicDeviceRecordKey":"c035c794-0a99-41a0-96c1-24bb010674df","publicVersionStatus":"New","deviceRecordStatus":"Published","publicVersionNumber":1,"publicVersionDate":"2023-06-09T00:00:00.000Z","devicePublishDate":"2023-06-01T00:00:00.000Z","deviceCommDistributionEndDate":null,"deviceCommDistributionStatus":"In Commercial Distribution","identifiers":{"identifier":[{"deviceId":"26950900961902","deviceIdType":"Package","deviceIdIssuingAgency":"GS1","containsDINumber":"06950900961908","pkgQuantity":5,"pkgDiscontinueDate":null,"pkgStatus":"In Commercial Distribution","pkgType":" box"},{"deviceId":"06950900961908","deviceIdType":"Primary","deviceIdIssuingAgency":"GS1","containsDINumber":null,"pkgQuantity":null,"pkgDiscontinueDate":null,"pkgStatus":null,"pkgType":null},{"deviceId":"46950900961906","deviceIdType":"Package","deviceIdIssuingAgency":"GS1","containsDINumber":"06950900961908","pkgQuantity":200,"pkgDiscontinueDate":null,"pkgStatus":"In Commercial Distribution","pkgType":"carton"}]},"brandName":"INT or KDL","versionModelNumber":"NIS02","catalogNumber":null,"dunsNumber":"420827639","companyName":"Shanghai Kindly Medical Instruments Co., Ltd.","deviceCount":1,"deviceDescription":" Interventional radiology percutaneous-access procedure kit.","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":[]},"gmdnTerms":{"gmdn":[{"gmdnCode":"60437","gmdnPTName":"Interventional radiology percutaneous-access kit, single-use","gmdnPTDefinition":"A collection of various instruments/devices (e.g., introducer sheath, dilator, guides, cannula, needle, angiographic catheter) intended to be used for percutaneous body-access to facilitate a radiological image-guided interventional radiology or surgical procedure [e.g., bile duct biopsy, percutaneous transhepatic cholangiogram, non-vascular drainage procedures, ultrasound-guided spinal surgery]. Some types are designed to function as a channel to facilitate the introduction of radiological image guidance devices (e.g., ultrasound probe/transducer) [not included]. It does not contain pharmaceuticals. This is a single-use device.","implantable":false,"gmdnCodeStatus":"Obsolete"}]},"productCodes":{"fdaProductCode":[{"productCode":"DYB","productCodeName":"Introducer, 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,"premarketSubmissions":{"premarketSubmission":[]}}