{"publicDeviceRecordKey":"60b1d347-4f06-45c6-9c42-54535e735460","publicVersionStatus":"Update","deviceRecordStatus":"Published","publicVersionNumber":5,"publicVersionDate":"2018-09-24T00:00:00.000Z","devicePublishDate":"2016-08-19T00:00:00.000Z","deviceCommDistributionEndDate":"2018-09-24T00:00:00.000Z","deviceCommDistributionStatus":"Not in Commercial Distribution","identifiers":{"identifier":[{"deviceId":"B09927001200","deviceIdType":"Primary","deviceIdIssuingAgency":"HIBCC","containsDINumber":null,"pkgQuantity":null,"pkgDiscontinueDate":null,"pkgStatus":null,"pkgType":null}]},"brandName":"TUBBS MITRAL VALVE DILATOR","versionModelNumber":"2700-120","catalogNumber":null,"dunsNumber":"040729840","companyName":"SONTEC INSTRUMENTS, INC.","deviceCount":1,"deviceDescription":"TUBBS MITRAL VALVE DILATOR \n","DMExempt":false,"premarketExempt":false,"deviceHCTP":false,"deviceKit":false,"deviceCombinationProduct":false,"singleUse":false,"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":"303-790-9411","phoneExtension":null,"email":"info@sontecinstruments.com"}]},"premarketSubmissions":{"premarketSubmission":[{"submissionNumber":"K100518","supplementNumber":"000"}]},"gmdnTerms":{"gmdn":[{"gmdnCode":"11255","gmdnPTName":"Mitral valve dilator","gmdnPTDefinition":"A hand-operated surgical instrument with specially designed expanding blades designed to dilate mitral stenosis during mitral valve surgery. It typically has forceps-like handles that include an adjustable, self-retaining mechanism to hold the blades at the desired expanded position. It is typically made of high-grade stainless steel and is available in various sizes. This is a reusable device.","implantable":false,"gmdnCodeStatus":"Active"}]},"productCodes":{"fdaProductCode":[{"productCode":"DWP","productCodeName":"Dilator, Vessel, Surgical"}]},"deviceSizes":{"deviceSize":[{"sizeType":"Outer Diameter","size":{"unit":"Millimeter","value":"8"},"sizeText":null,"sizeString":"Outer Diameter: 8 Millimeter"}]},"environmentalConditions":{"storageHandling":[]},"sterilization":{"deviceSterile":false,"sterilizationPriorToUse":true,"methodTypes":{"sterilizationMethod":["Moist Heat or Steam Sterilization","Dry Heat Sterilization"]}},"xmlns":"http://www.fda.gov/cdrh/gudid","xsi":"http://www.w3.org/2001/XMLSchema-instance","anomaly":null}