{"publicDeviceRecordKey":"4051bdfb-e3bf-4ee9-8c30-f1e5831d429c","publicVersionStatus":"New","deviceRecordStatus":"Published","publicVersionNumber":1,"publicVersionDate":"2025-10-24T00:00:00.000Z","devicePublishDate":"2025-10-16T00:00:00.000Z","deviceCommDistributionEndDate":null,"deviceCommDistributionStatus":"In Commercial Distribution","identifiers":{"identifier":[{"deviceId":"00817355027770","deviceIdType":"Primary","deviceIdIssuingAgency":"GS1","containsDINumber":null,"pkgQuantity":null,"pkgDiscontinueDate":null,"pkgStatus":null,"pkgType":null}]},"brandName":"KLARITY MEDICAL","versionModelNumber":"R460-3242S5T","catalogNumber":null,"dunsNumber":"034824691","companyName":"Klarity Medical Products, LLC","deviceCount":1,"deviceDescription":"Klarity White™ S-type Narrow Head and Shoulder Mask, 42% perforation, 3.2mm","DMExempt":false,"premarketExempt":false,"deviceHCTP":false,"deviceKit":false,"deviceCombinationProduct":false,"singleUse":false,"lotBatch":true,"serialNumber":false,"manufacturingDate":true,"expirationDate":true,"donationIdNumber":false,"labeledContainsNRL":false,"labeledNoNRL":false,"MRISafetyStatus":"MR Safe","rx":false,"otc":false,"contacts":{"customerContact":[]},"premarketSubmissions":{"premarketSubmission":[{"submissionNumber":"K022708","supplementNumber":"000"}]},"gmdnTerms":{"gmdn":[{"gmdnCode":"40896","gmdnPTName":"Patient positioning thermoplastic mould material","gmdnPTDefinition":"A thermoplastic material used to create moulds of a patient's body. It is commonly supplied as sheets or meshes of thermoplastic material that have been coated with polyurethane for ease of handling and positioning. Most of these materials are softened by heating in hot water and while softened, are moulded around the patient's anatomy. When cooled, it hardens to form a custom-made mould or cast of that part of the body. After the moulding process is complete, it is typically attached to a board, frame, or another patient positioning system (PPS) or immobilization device. After application, this device cannot be reused (i.e., remoulded).","implantable":false,"gmdnCodeStatus":"Active"}]},"productCodes":{"fdaProductCode":[{"productCode":"IYE","productCodeName":"Accelerator, Linear, Medical"}]},"deviceSizes":{"deviceSize":[]},"environmentalConditions":{"storageHandling":[]},"sterilization":{"deviceSterile":false,"sterilizationPriorToUse":false,"methodTypes":{"sterilizationMethod":[]}},"xmlns":"http://www.fda.gov/cdrh/gudid","xsi":"http://www.w3.org/2001/XMLSchema-instance","anomaly":null}