{"publicDeviceRecordKey":"40746570-356b-48ec-b161-8a03e6933afa","publicVersionStatus":"Update","deviceRecordStatus":"Published","publicVersionNumber":2,"publicVersionDate":"2025-05-02T00:00:00.000Z","devicePublishDate":"2024-10-21T00:00:00.000Z","deviceCommDistributionEndDate":null,"deviceCommDistributionStatus":"In Commercial Distribution","identifiers":{"identifier":[{"deviceId":"H965459151","deviceIdType":"Package","deviceIdIssuingAgency":"HIBCC","containsDINumber":"H965459150","pkgQuantity":5,"pkgDiscontinueDate":null,"pkgStatus":"In Commercial Distribution","pkgType":"Box"},{"deviceId":"H965459150","deviceIdType":"Primary","deviceIdIssuingAgency":"HIBCC","containsDINumber":null,"pkgQuantity":null,"pkgDiscontinueDate":null,"pkgStatus":null,"pkgType":null}]},"brandName":"Navilyst Medical","versionModelNumber":"45-915","catalogNumber":null,"dunsNumber":"079252781","companyName":"Angiodynamics, Inc.","deviceCount":1,"deviceDescription":"MiniStick II Microintroducer Kit 4F, 45cm Nitinol/SS Wire","DMExempt":false,"premarketExempt":true,"deviceHCTP":false,"deviceKit":false,"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":"+1(800)772-6446","phoneExtension":null,"email":"customerservice@angiodynamics.com"}]},"gmdnTerms":{"gmdn":[{"gmdnCode":"58865","gmdnPTName":"Vascular catheter introduction set, nonimplantable","gmdnPTDefinition":"A collection of nonimplantable, invasive devices intended to provide percutaneous vascular access to enable introduction of a catheter (not included) into the vascular system. It includes a non-steerable introducer sheath with an inner obturator/dilator, and typically an additional access device(s) [e.g., guidewire, introducer needle, syringe, additional dilators] which may include a haemostatic valve to control blood loss, usually to enable arterial access. This is a single-use device.","implantable":false,"gmdnCodeStatus":"Active"}]},"productCodes":{"fdaProductCode":[{"productCode":"OFL","productCodeName":"Percutaneous Sheath Introducer Kit"}]},"deviceSizes":{"deviceSize":[{"sizeType":"Needle Gauge","size":{"unit":"Gauge","value":"21"},"sizeText":null,"sizeString":"Needle Gauge: 21 Gauge"},{"sizeType":"Catheter Gauge","size":{"unit":"French","value":"4"},"sizeText":null,"sizeString":"Catheter Gauge: 4 French"},{"sizeType":"Guidewire Length","size":{"unit":"Centimeter","value":"45"},"sizeText":null,"sizeString":"Guidewire Length: 45 Centimeter"},{"sizeType":"Guidewire Diameter","size":{"unit":"Inch","value":".018"},"sizeText":null,"sizeString":"Guidewire Diameter: .018 Inch"},{"sizeType":"Catheter Length","size":{"unit":"Centimeter","value":"7"},"sizeText":null,"sizeString":"Catheter Length: 7 Centimeter"}]},"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":[]}}