<?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>27cf104b-946e-48d6-b73c-6ec9581abd4f</publicDeviceRecordKey><publicVersionStatus>New</publicVersionStatus><deviceRecordStatus>Published</deviceRecordStatus><publicVersionNumber>1</publicVersionNumber><publicVersionDate>2023-02-28</publicVersionDate><devicePublishDate>2023-02-20</devicePublishDate><deviceCommDistributionEndDate>2123-02-20</deviceCommDistributionEndDate><deviceCommDistributionStatus>In Commercial Distribution</deviceCommDistributionStatus><identifiers><identifier><deviceId>B7755800</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>PHASOR</brandName><versionModelNumber>5.80</versionModelNumber><catalogNumber>5.80</catalogNumber><dunsNumber>111926675</dunsNumber><companyName>PHASOR HEALTH LLC</companyName><deviceCount>1</deviceCount><deviceDescription>Phasor Drill 5.80-mm diameter, ~70-mm length, with Depth Stop Extension (DSE) tapered</deviceDescription><DMExempt>false</DMExempt><premarketExempt>false</premarketExempt><deviceHCTP>false</deviceHCTP><deviceKit>false</deviceKit><deviceCombinationProduct>false</deviceCombinationProduct><singleUse>true</singleUse><lotBatch>true</lotBatch><serialNumber>false</serialNumber><manufacturingDate>true</manufacturingDate><expirationDate>true</expirationDate><donationIdNumber>false</donationIdNumber><labeledContainsNRL>false</labeledContainsNRL><labeledNoNRL>false</labeledNoNRL><MRISafetyStatus>MR Unsafe</MRISafetyStatus><rx>true</rx><otc>false</otc><contacts/><premarketSubmissions><premarketSubmission><submissionNumber>K161704</submissionNumber><supplementNumber>000</supplementNumber></premarketSubmission></premarketSubmissions><gmdnTerms><gmdn><gmdnCode>46277</gmdnCode><gmdnPTName>Automatic cranial perforator, single-use</gmdnPTName><gmdnPTDefinition>A sterile, metallic rotary endpiece designed to cut a circular section, or sections, of the skull vault (calvarium) to provide access to the interior for diagnostic/therapeutic purposes or for the removal of a bone flap for brain surgery. It typically consists of two coaxial drill shafts (one rotating inside the other), a drive shank that enables connection to a powered (either electrical or pneumatic) handpiece, and a built-in clutch mechanism. The inner drill shaft extends slightly beyond the outer cutter in such a way that when the inner drill shafts penetrates the inner table of the skull the clutch mechanism disengages. This is a single-use device.</gmdnPTDefinition><implantable>false</implantable><gmdnCodeStatus>Active</gmdnCodeStatus></gmdn></gmdnTerms><productCodes><fdaProductCode><productCode>HBE</productCode><productCodeName>Drills, Burrs, Trephines &amp; Accessories (Simple, Powered)</productCodeName></fdaProductCode></productCodes><deviceSizes/><environmentalConditions/><sterilization><deviceSterile>true</deviceSterile><sterilizationPriorToUse>false</sterilizationPriorToUse><methodTypes/></sterilization></device>