<?xml version='1.0' encoding='UTF-8'?><device xmlns='http://www.fda.gov/cdrh/gudid' xmlns:xsi='http://www.w3.org/2001/XMLSchema-instance'><publicDeviceRecordKey>6b19ef94-0c81-4c95-be29-b716bde4d837</publicDeviceRecordKey><publicVersionStatus>Update</publicVersionStatus><deviceRecordStatus>Published</deviceRecordStatus><publicVersionNumber>2</publicVersionNumber><publicVersionDate>2023-12-04</publicVersionDate><devicePublishDate>2022-12-20</devicePublishDate><deviceCommDistributionEndDate xsi:nil="true"/><deviceCommDistributionStatus>In Commercial Distribution</deviceCommDistributionStatus><identifiers><identifier><deviceId>RF23501100</deviceId><deviceIdType>Primary</deviceIdType><deviceIdIssuingAgency>HIBCC</deviceIdIssuingAgency><containsDINumber xsi:nil="true"/><pkgQuantity xsi:nil="true"/><pkgDiscontinueDate xsi:nil="true"/><pkgStatus xsi:nil="true"/><pkgType xsi:nil="true"/></identifier></identifiers><brandName>ROYLA FLUSH</brandName><versionModelNumber>RF235-01-10</versionModelNumber><catalogNumber>RF235-01-10</catalogNumber><dunsNumber>009346404</dunsNumber><companyName>Royal Knit, Inc.</companyName><deviceCount>1</deviceCount><deviceDescription>(10&quot;-12&quot;) Royal Flush 2,3,5 Ply White Heavy  X-Large With Reinforced Hole 12 Pack</deviceDescription><DMExempt>true</DMExempt><premarketExempt>true</premarketExempt><deviceHCTP>false</deviceHCTP><deviceKit>false</deviceKit><deviceCombinationProduct>false</deviceCombinationProduct><singleUse>true</singleUse><lotBatch>true</lotBatch><serialNumber>false</serialNumber><manufacturingDate>false</manufacturingDate><expirationDate>false</expirationDate><donationIdNumber>false</donationIdNumber><labeledContainsNRL>false</labeledContainsNRL><labeledNoNRL>false</labeledNoNRL><MRISafetyStatus>Labeling does not contain MRI Safety Information</MRISafetyStatus><rx>false</rx><otc>true</otc><contacts/><gmdnTerms><gmdn><gmdnCode>13635</gmdnCode><gmdnPTName>Stump sock</gmdnPTName><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.</gmdnPTDefinition><implantable>false</implantable><gmdnCodeStatus>Active</gmdnCodeStatus></gmdn></gmdnTerms><productCodes><fdaProductCode><productCode>FQL</productCode><productCodeName>Stocking, Medical Support (For General Medical Purposes)</productCodeName></fdaProductCode></productCodes><deviceSizes/><environmentalConditions/><sterilization><deviceSterile>false</deviceSterile><sterilizationPriorToUse>false</sterilizationPriorToUse><methodTypes/></sterilization></device>