<?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>32d6644b-85aa-48d1-9e44-9cd95dde43c5</publicDeviceRecordKey><publicVersionStatus>New</publicVersionStatus><deviceRecordStatus>Published</deviceRecordStatus><publicVersionNumber>1</publicVersionNumber><publicVersionDate>2022-04-14</publicVersionDate><devicePublishDate>2022-04-06</devicePublishDate><deviceCommDistributionEndDate xsi:nil="true"/><deviceCommDistributionStatus>In Commercial Distribution</deviceCommDistributionStatus><identifiers><identifier><deviceId>04946329052701</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></identifiers><brandName>Dural Elevator</brandName><versionModelNumber>07-008-23</versionModelNumber><catalogNumber>07-008-23</catalogNumber><dunsNumber>690677802</dunsNumber><companyName>MIZUHO CORPORATION</companyName><deviceCount>1</deviceCount><deviceDescription>Dural Elevator, Flexible Shaft</deviceDescription><DMExempt>false</DMExempt><premarketExempt>true</premarketExempt><deviceHCTP>false</deviceHCTP><deviceKit>false</deviceKit><deviceCombinationProduct>false</deviceCombinationProduct><singleUse>false</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>true</rx><otc>false</otc><contacts><customerContact><phone>9999999999</phone><phoneExtension xsi:nil="true"/><email>regulatory@mizuho.co.jp</email></customerContact></contacts><gmdnTerms><gmdn><gmdnCode>35335</gmdnCode><gmdnPTName>Dura mater dissector</gmdnPTName><gmdnPTDefinition>A hand-held surgical instrument, usually softly rounded and curved at the working end, used to separate the outermost membrane covering of the brain and spinal cord from the inner membranes. It is usually designed with a handle which continues into a shaft that terminates at the distal end with a rounded curved tip, or it can be double-ended. It is made of high-grade stainless steel, comes in various shapes and sizes. This is a reusable device.</gmdnPTDefinition><implantable>false</implantable><gmdnCodeStatus>Active</gmdnCodeStatus></gmdn></gmdnTerms><productCodes><fdaProductCode><productCode>HAO</productCode><productCodeName>Instrument, Surgical, Non-Powered</productCodeName></fdaProductCode></productCodes><deviceSizes><deviceSize><sizeType>Length</sizeType><size unit="Millimeter" value="225"/><sizeText xsi:nil="true"/></deviceSize></deviceSizes><environmentalConditions/><sterilization><deviceSterile>false</deviceSterile><sterilizationPriorToUse>true</sterilizationPriorToUse><methodTypes><sterilizationMethod>Moist Heat or Steam Sterilization</sterilizationMethod></methodTypes></sterilization></device>