{"publicDeviceRecordKey":"e0ab8230-751d-4738-a6ad-6325bbe5cddb","publicVersionStatus":"Update","deviceRecordStatus":"Published","publicVersionNumber":2,"publicVersionDate":"2023-12-04T00:00:00.000Z","devicePublishDate":"2022-09-14T00:00:00.000Z","deviceCommDistributionEndDate":null,"deviceCommDistributionStatus":"In Commercial Distribution","identifiers":{"identifier":[{"deviceId":"G296RF8AB140","deviceIdType":"Primary","deviceIdIssuingAgency":"HIBCC","containsDINumber":null,"pkgQuantity":null,"pkgDiscontinueDate":null,"pkgStatus":null,"pkgType":null}]},"brandName":"ROYAL FLUSH","versionModelNumber":"RF8-A/B-14","catalogNumber":"RF8-A/B-14","dunsNumber":"009346404","companyName":"Royal Knit, Inc.","deviceCount":1,"deviceDescription":"(12\"-14\") Royal Flush 8 Ply White  X-Small No Hole","DMExempt":true,"premarketExempt":true,"deviceHCTP":false,"deviceKit":false,"deviceCombinationProduct":false,"singleUse":true,"lotBatch":true,"serialNumber":false,"manufacturingDate":false,"expirationDate":false,"donationIdNumber":false,"labeledContainsNRL":false,"labeledNoNRL":false,"MRISafetyStatus":"Labeling does not contain MRI Safety Information","rx":false,"otc":true,"contacts":{"customerContact":[]},"gmdnTerms":{"gmdn":[{"gmdnCode":"13635","gmdnPTName":"Stump sock","gmdnPTDefinition":"A sleeve designed to be worn over a residual limb to improve contact between the stump and the socket interface of an external limb prosthesis/orthosis to: 1) provide a cushion for the alleviation of friction; 2) enable a more comfortable and stable use of the prosthesis/orthosis; and 3) function as an aid in the daily fitting of the prosthesis by an amputee patient. It is typically made of textile materials (e.g., wool, cotton). This is a single-patient device that may be reapplied to the patient over a short term (single-use) before being discarded.","implantable":false,"gmdnCodeStatus":"Active"}]},"productCodes":{"fdaProductCode":[{"productCode":"FQL","productCodeName":"Stocking, Medical Support (For General Medical Purposes)"}]},"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,"premarketSubmissions":{"premarketSubmission":[]}}