<?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>e4f4f14c-cd61-4f92-9d72-920d19a302ad</publicDeviceRecordKey><publicVersionStatus>Update</publicVersionStatus><deviceRecordStatus>Published</deviceRecordStatus><publicVersionNumber>4</publicVersionNumber><publicVersionDate>2019-12-18</publicVersionDate><devicePublishDate>2016-09-26</devicePublishDate><deviceCommDistributionEndDate xsi:nil="true"/><deviceCommDistributionStatus>In Commercial Distribution</deviceCommDistributionStatus><identifiers><identifier><deviceId>28033003345232</deviceId><deviceIdType>Package</deviceIdType><deviceIdIssuingAgency>GS1</deviceIdIssuingAgency><containsDINumber>08033003345238</containsDINumber><pkgQuantity>5</pkgQuantity><pkgDiscontinueDate xsi:nil="true"/><pkgStatus>In Commercial Distribution</pkgStatus><pkgType xsi:nil="true"/></identifier><identifier><deviceId>08033003345238</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>38033003345239</deviceId><deviceIdType>Package</deviceIdType><deviceIdIssuingAgency>GS1</deviceIdIssuingAgency><containsDINumber>08033003345238</containsDINumber><pkgQuantity>10</pkgQuantity><pkgDiscontinueDate xsi:nil="true"/><pkgStatus>In Commercial Distribution</pkgStatus><pkgType xsi:nil="true"/></identifier></identifiers><brandName>PRECISA</brandName><versionModelNumber>PRECISA</versionModelNumber><catalogNumber>PRE 1610</catalogNumber><dunsNumber>428898555</dunsNumber><companyName>H.S. HOSPITAL SERVICE SPA</companyName><deviceCount>1</deviceCount><deviceDescription>PRECISA 16GX100MM</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>false</manufacturingDate><expirationDate>true</expirationDate><donationIdNumber>false</donationIdNumber><labeledContainsNRL>false</labeledContainsNRL><labeledNoNRL>true</labeledNoNRL><MRISafetyStatus>MR Unsafe</MRISafetyStatus><rx>true</rx><otc>false</otc><contacts><customerContact><phone>+39069201961</phone><phoneExtension xsi:nil="true"/><email>hs@hshospitalservice.com</email></customerContact></contacts><premarketSubmissions><premarketSubmission><submissionNumber>K002944</submissionNumber><supplementNumber>000</supplementNumber></premarketSubmission></premarketSubmissions><gmdnTerms><gmdn><gmdnCode>58990</gmdnCode><gmdnPTName>Side-notch biopsy gun handpiece/needle</gmdnPTName><gmdnPTDefinition>A hand-operated, non-electronic, surgical instrument designed for the automatic extraction of a small tissue sample from an anatomical structure (a biopsy), while causing minimal surrounding tissue damage, for tissue pathological examination/testing. It consists of both: 1) a handpiece with a spring-loaded mechanism and release trigger; and 2) a percutaneous, distal, needle-like portion with a side-notch cutter which when activated causes a sharp, sliding cannula to slice a segment of tissue. It is typically used to obtain samples of soft tissue from the kidneys, prostate, pancreas, liver, and breast, often performed under image guidance. This is a single-use device.</gmdnPTDefinition><implantable>false</implantable><gmdnCodeStatus>Active</gmdnCodeStatus></gmdn></gmdnTerms><productCodes><fdaProductCode><productCode>FCG</productCode><productCodeName>Biopsy Needle</productCodeName></fdaProductCode></productCodes><deviceSizes><deviceSize><sizeType>Needle Gauge</sizeType><size unit="Gauge" value="16"/><sizeText xsi:nil="true"/></deviceSize><deviceSize><sizeType>Length</sizeType><size unit="Millimeter" value="100"/><sizeText xsi:nil="true"/></deviceSize></deviceSizes><environmentalConditions/><sterilization><deviceSterile>true</deviceSterile><sterilizationPriorToUse>false</sterilizationPriorToUse><methodTypes/></sterilization></device>