{"publicDeviceRecordKey":"8d81a4bb-4181-4235-bd6f-e0c9e3c9d328","publicVersionStatus":"Update","deviceRecordStatus":"Published","publicVersionNumber":5,"publicVersionDate":"2024-09-11T00:00:00.000Z","devicePublishDate":"2018-06-29T00:00:00.000Z","deviceCommDistributionEndDate":"2023-01-10T00:00:00.000Z","deviceCommDistributionStatus":"Not in Commercial Distribution","identifiers":{"identifier":[{"deviceId":"M752SS93355","deviceIdType":"Package","deviceIdIssuingAgency":"HIBCC","containsDINumber":"M752SS93350","pkgQuantity":25,"pkgDiscontinueDate":"2023-01-10","pkgStatus":"Not in Commercial Distribution","pkgType":"outer box"},{"deviceId":"M752SS93350","deviceIdType":"Primary","deviceIdIssuingAgency":"HIBCC","containsDINumber":null,"pkgQuantity":null,"pkgDiscontinueDate":null,"pkgStatus":null,"pkgType":null}]},"brandName":"Stradis Medical, LLC.","versionModelNumber":"SS9335","catalogNumber":null,"dunsNumber":"174262477","companyName":"STRADIS MEDICAL, LLC","deviceCount":1,"deviceDescription":"Sani Sleeve™ Barrier Protection For Handpieces And Hoses","DMExempt":false,"premarketExempt":false,"deviceHCTP":false,"deviceKit":true,"deviceCombinationProduct":false,"singleUse":true,"lotBatch":true,"serialNumber":false,"manufacturingDate":false,"expirationDate":true,"donationIdNumber":false,"labeledContainsNRL":false,"labeledNoNRL":true,"MRISafetyStatus":"Labeling does not contain MRI Safety Information","rx":true,"otc":false,"contacts":{"customerContact":[{"phone":"770-962-2425","phoneExtension":null,"email":"SALES@STRADISHEALTHCARE.COM"}]},"gmdnTerms":{"gmdn":[{"gmdnCode":"12535","gmdnPTName":"Medical equipment/instrument drape, single-use","gmdnPTDefinition":"A flexible polymer sheet/bag/sleeve designed to form a protective water-resistant enclosure around a piece of medical equipment/instrument (e.g., C-arm, surgical laser/camera/microscope, examination table/chair) and/or components (e.g., cables, tubes, headrest). It is intended as a hygienic barrier to protect the equipment/instrument from soiling and/or contamination when used inside, or within the vicinity of, a hygienic area; it may have patient contact, however it is not intended to be introduced into a body cavity (noninvasive). It is neither a dedicated handle cover, device cap nor an ultrasound transducer cover. This is a single-use device.","implantable":false,"gmdnCodeStatus":"Active"}]},"productCodes":{"fdaProductCode":[{"productCode":"KQM","productCodeName":"Camera, Surgical And Accessories"}]},"deviceSizes":{"deviceSize":[]},"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":[]}}