{"publicDeviceRecordKey":"ba555c07-3c3a-48e8-846c-e0f19b332b07","publicVersionStatus":"New","deviceRecordStatus":"Published","publicVersionNumber":1,"publicVersionDate":"2025-01-28T00:00:00.000Z","devicePublishDate":"2025-01-20T00:00:00.000Z","deviceCommDistributionEndDate":null,"deviceCommDistributionStatus":"In Commercial Distribution","identifiers":{"identifier":[{"deviceId":"B356JB430100","deviceIdType":"Primary","deviceIdIssuingAgency":"HIBCC","containsDINumber":null,"pkgQuantity":null,"pkgDiscontinueDate":null,"pkgStatus":null,"pkgType":null}]},"brandName":"American Medicals","versionModelNumber":"1","catalogNumber":null,"dunsNumber":"109909627","companyName":"American Medicals","deviceCount":1,"deviceDescription":null,"DMExempt":false,"premarketExempt":true,"deviceHCTP":false,"deviceKit":false,"deviceCombinationProduct":false,"singleUse":false,"lotBatch":false,"serialNumber":false,"manufacturingDate":false,"expirationDate":false,"donationIdNumber":false,"labeledContainsNRL":false,"labeledNoNRL":false,"MRISafetyStatus":"Labeling does not contain MRI Safety Information","rx":false,"otc":false,"contacts":{"customerContact":[]},"gmdnTerms":{"gmdn":[{"gmdnCode":"11264","gmdnPTName":"Fallopian tube dilator","gmdnPTDefinition":"A surgical instrument used for the mechanical augmentation (stretching and enlarging) of the internal lumen of the Fallopian tube during a gynaecological/obstetrical procedure. It is a rod-like device with a long, slender, hollow or solid body and a rounded nose at its distal end, that is available in a variety of sizes and typically made of metal. This is a reusable device.","implantable":false,"gmdnCodeStatus":"Active"}]},"productCodes":{"fdaProductCode":[{"productCode":"HTO","productCodeName":"Reamer"}]},"deviceSizes":{"deviceSize":[]},"environmentalConditions":{"storageHandling":[]},"sterilization":{"deviceSterile":false,"sterilizationPriorToUse":true,"methodTypes":{"sterilizationMethod":["Microwave Radiation"]}},"xmlns":"http://www.fda.gov/cdrh/gudid","xsi":"http://www.w3.org/2001/XMLSchema-instance","anomaly":null,"premarketSubmissions":{"premarketSubmission":[]}}