{"publicDeviceRecordKey":"42208f1e-3cc6-4c66-90d7-77908bae5a2c","publicVersionStatus":"Update","deviceRecordStatus":"Published","publicVersionNumber":3,"publicVersionDate":"2026-02-09T00:00:00.000Z","devicePublishDate":"2023-08-18T00:00:00.000Z","deviceCommDistributionEndDate":null,"deviceCommDistributionStatus":"In Commercial Distribution","identifiers":{"identifier":[{"deviceId":"B366SN0445175","deviceIdType":"Primary","deviceIdIssuingAgency":"HIBCC","containsDINumber":null,"pkgQuantity":null,"pkgDiscontinueDate":null,"pkgStatus":null,"pkgType":null}]},"brandName":"Sinuscope","versionModelNumber":"R00","catalogNumber":"SN0445175","dunsNumber":"043555079","companyName":"Ecleris","deviceCount":1,"deviceDescription":"Sinuscope 4mm Ø, 45°, 175mm L","DMExempt":false,"premarketExempt":false,"deviceHCTP":false,"deviceKit":false,"deviceCombinationProduct":false,"singleUse":false,"lotBatch":false,"serialNumber":true,"manufacturingDate":true,"expirationDate":false,"donationIdNumber":false,"labeledContainsNRL":false,"labeledNoNRL":false,"MRISafetyStatus":"Labeling does not contain MRI Safety Information","rx":false,"otc":false,"contacts":{"customerContact":[{"phone":"7864837490","phoneExtension":null,"email":"carlosb@ecleris.com"}]},"premarketSubmissions":{"premarketSubmission":[{"submissionNumber":"K131323","supplementNumber":"000"}]},"gmdnTerms":{"gmdn":[{"gmdnCode":"37180","gmdnPTName":"Rigid optical sinoscope","gmdnPTDefinition":"An endoscope with a rigid inserted portion intended for the visual examination and treatment of the paranasal sinuses during an ear/nose/throat (ENT) intervention. It is inserted through a naris. Anatomical images are transmitted to the user through relayed lens optics or a fibreoptic bundle. This is a reusable device.","implantable":false,"gmdnCodeStatus":"Active"}]},"productCodes":{"fdaProductCode":[{"productCode":"EOB","productCodeName":"Nasopharyngoscope (Flexible Or Rigid)"}]},"deviceSizes":{"deviceSize":[]},"environmentalConditions":{"storageHandling":[{"storageHandlingType":"Storage Environment Temperature","storageHandlingHigh":{"unit":"Degrees Celsius","value":"40"},"storageHandlingLow":{"unit":"Degrees Celsius","value":"-10"},"storageHandlingSpecialConditionText":null},{"storageHandlingType":"Storage Environment Humidity","storageHandlingHigh":{"unit":"Percent (%) Relative Humidity","value":"90"},"storageHandlingLow":{"unit":"Percent (%) Relative Humidity","value":"19"},"storageHandlingSpecialConditionText":null}]},"sterilization":{"deviceSterile":false,"sterilizationPriorToUse":false,"methodTypes":{"sterilizationMethod":[]}},"xmlns":"http://www.fda.gov/cdrh/gudid","xsi":"http://www.w3.org/2001/XMLSchema-instance","anomaly":null}