{"publicDeviceRecordKey":"14d53864-efa7-48c0-a0e6-1a696dff8cfa","publicVersionStatus":"Update","deviceRecordStatus":"Published","publicVersionNumber":5,"publicVersionDate":"2022-08-30T00:00:00.000Z","devicePublishDate":"2015-09-20T00:00:00.000Z","deviceCommDistributionEndDate":null,"deviceCommDistributionStatus":"In Commercial Distribution","identifiers":{"identifier":[{"deviceId":"EBESSS20000","deviceIdType":"Primary","deviceIdIssuingAgency":"HIBCC","containsDINumber":null,"pkgQuantity":null,"pkgDiscontinueDate":null,"pkgStatus":null,"pkgType":null},{"deviceId":"EBESSS20001","deviceIdType":"Package","deviceIdIssuingAgency":"HIBCC","containsDINumber":"EBESSS20000","pkgQuantity":1,"pkgDiscontinueDate":null,"pkgStatus":"In Commercial Distribution","pkgType":"Carton"}]},"brandName":"Salman FES Stent","versionModelNumber":"SS2000","catalogNumber":"SS2000","dunsNumber":"131855157","companyName":"Boston Medical Products, Inc.","deviceCount":1,"deviceDescription":null,"DMExempt":false,"premarketExempt":false,"deviceHCTP":false,"deviceKit":false,"deviceCombinationProduct":false,"singleUse":true,"lotBatch":true,"serialNumber":false,"manufacturingDate":false,"expirationDate":true,"donationIdNumber":false,"labeledContainsNRL":false,"labeledNoNRL":true,"MRISafetyStatus":"MR Safe","rx":true,"otc":false,"contacts":{"customerContact":[{"phone":"1-800-433-2674","phoneExtension":null,"email":"info@bosmed.com"}]},"premarketSubmissions":{"premarketSubmission":[{"submissionNumber":"K922902","supplementNumber":"000"}]},"gmdnTerms":{"gmdn":[{"gmdnCode":"48121","gmdnPTName":"Paranasal sinus spacer","gmdnPTDefinition":"A sterile device temporarily introduced into the sinus to maintain an opening and prevent obstruction. It is used for the local moistening of the sinuses through delivery of a selected fluid (e.g., saline or a drug) to treat sinusitis. It is typically designed as a microflow catheter with a micropore reservoir at the distal end which gradually releases the fluid. The implantation procedure is assisted through fluoroscopy or endoscopy. A disposable sinus spacer deployment device will typically be included.","implantable":false,"gmdnCodeStatus":"Obsolete"}]},"productCodes":{"fdaProductCode":[{"productCode":"KAM","productCodeName":"Cannula, Sinus"}]},"deviceSizes":{"deviceSize":[]},"environmentalConditions":{"storageHandling":[{"storageHandlingType":"Special Storage Condition, Specify","storageHandlingHigh":{"unit":"","value":""},"storageHandlingLow":{"unit":"","value":""},"storageHandlingSpecialConditionText":"Keep dry"},{"storageHandlingType":"Special Storage Condition, Specify","storageHandlingHigh":{"unit":"","value":""},"storageHandlingLow":{"unit":"","value":""},"storageHandlingSpecialConditionText":"Keep away from sunlight"}]},"sterilization":{"deviceSterile":true,"sterilizationPriorToUse":false,"methodTypes":{"sterilizationMethod":[]}},"xmlns":"http://www.fda.gov/cdrh/gudid","xsi":"http://www.w3.org/2001/XMLSchema-instance","anomaly":null}