<?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>61ef8970-243d-42e0-bc91-d30f8f3244c1</publicDeviceRecordKey><publicVersionStatus>Update</publicVersionStatus><deviceRecordStatus>Published</deviceRecordStatus><publicVersionNumber>2</publicVersionNumber><publicVersionDate>2024-11-14</publicVersionDate><devicePublishDate>2022-08-31</devicePublishDate><deviceCommDistributionEndDate>2024-09-23</deviceCommDistributionEndDate><deviceCommDistributionStatus>Not in Commercial Distribution</deviceCommDistributionStatus><identifiers><identifier><deviceId>14719882250474</deviceId><deviceIdType>Package</deviceIdType><deviceIdIssuingAgency>GS1</deviceIdIssuingAgency><containsDINumber>04719882250477</containsDINumber><pkgQuantity>5</pkgQuantity><pkgDiscontinueDate>2024-09-23</pkgDiscontinueDate><pkgStatus>Not in Commercial Distribution</pkgStatus><pkgType>Carton</pkgType></identifier><identifier><deviceId>04719882250477</deviceId><deviceIdType>Primary</deviceIdType><deviceIdIssuingAgency>GS1</deviceIdIssuingAgency><containsDINumber xsi:nil="true"/><pkgQuantity xsi:nil="true"/><pkgDiscontinueDate xsi:nil="true"/><pkgStatus xsi:nil="true"/><pkgType xsi:nil="true"/></identifier><identifier><deviceId>04719882250460</deviceId><deviceIdType>Unit of Use</deviceIdType><deviceIdIssuingAgency>GS1</deviceIdIssuingAgency><containsDINumber xsi:nil="true"/><pkgQuantity xsi:nil="true"/><pkgDiscontinueDate xsi:nil="true"/><pkgStatus xsi:nil="true"/><pkgType xsi:nil="true"/></identifier></identifiers><brandName>Copioumed</brandName><versionModelNumber>SCN0B201-1</versionModelNumber><catalogNumber xsi:nil="true"/><dunsNumber>658318113</dunsNumber><companyName>COPIOUMED INTERNATIONAL INC.</companyName><deviceCount>100</deviceCount><deviceDescription>Copioumed Surgical Cap with Ties offers a comfortable and enhanced fit for wearers, as it is equipped with ties on the back for an adjustable size. The wide-forehead surgical cap’s design also ensures a close fit, especially for people with long hair. In addition, the wide and flat forehead contains no elastic, so this surgical cap won’t leave a mark. Which offers protection against particles- and hair-related cross-contamination, making it the preferred line for the operating theatre.</deviceDescription><DMExempt>false</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>true</expirationDate><donationIdNumber>false</donationIdNumber><labeledContainsNRL>false</labeledContainsNRL><labeledNoNRL>true</labeledNoNRL><MRISafetyStatus>Labeling does not contain MRI Safety Information</MRISafetyStatus><rx>false</rx><otc>false</otc><contacts><customerContact><phone>+886227721815</phone><phoneExtension xsi:nil="true"/><email>info@gcv.com.tw</email></customerContact></contacts><gmdnTerms><gmdn><gmdnCode>32297</gmdnCode><gmdnPTName>Surgical cap, single-use</gmdnPTName><gmdnPTDefinition>A head covering designed as a cap intended to be worn by surgical staff during an operation to protect both the patient and themselves from the transfer of microorganisms, body fluids, and particulate material; it may also be used as a hygienic head covering in other healthcare settings. It is usually made of reinforced paper or non-woven materials. This is a single-use device.</gmdnPTDefinition><implantable>false</implantable><gmdnCodeStatus>Active</gmdnCodeStatus></gmdn></gmdnTerms><productCodes><fdaProductCode><productCode>FYF</productCode><productCodeName>Cap, Surgical</productCodeName></fdaProductCode></productCodes><deviceSizes/><environmentalConditions/><sterilization><deviceSterile>false</deviceSterile><sterilizationPriorToUse>false</sterilizationPriorToUse><methodTypes/></sterilization></device>