<?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>7557c1a3-e2a7-4cfe-8b60-4ee5dce2f3cc</publicDeviceRecordKey><publicVersionStatus>Update</publicVersionStatus><deviceRecordStatus>Published</deviceRecordStatus><publicVersionNumber>5</publicVersionNumber><publicVersionDate>2019-12-18</publicVersionDate><devicePublishDate>2016-09-23</devicePublishDate><deviceCommDistributionEndDate xsi:nil="true"/><deviceCommDistributionStatus>In Commercial Distribution</deviceCommDistributionStatus><identifiers><identifier><deviceId>H671DLS1001</deviceId><deviceIdType>Package</deviceIdType><deviceIdIssuingAgency>HIBCC</deviceIdIssuingAgency><containsDINumber>H671DLS1000</containsDINumber><pkgQuantity>10</pkgQuantity><pkgDiscontinueDate xsi:nil="true"/><pkgStatus>In Commercial Distribution</pkgStatus><pkgType>Overpack</pkgType></identifier><identifier><deviceId>H671DLS1000</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>LETZ</brandName><versionModelNumber>Electrode Sampler #1</versionModelNumber><catalogNumber>DLS-100</catalogNumber><dunsNumber>094651270</dunsNumber><companyName>UTAH MEDICAL PRODUCTS, INC.</companyName><deviceCount>1</deviceCount><deviceDescription>Electrode Sampler #1, Disposable Electrosurgical Loop and Ball Electrodes, Includes 1 ea. DLP-S11, 2 ea. DLP-M11, 1 ea. DLP-W11, 1 ea. DBL-311, &amp; 1 ea. DBL-511</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>Labeling does not contain MRI Safety Information</MRISafetyStatus><rx>true</rx><otc>false</otc><contacts><customerContact><phone>800-533-4984</phone><phoneExtension xsi:nil="true"/><email>customer@utahmed.com</email></customerContact></contacts><premarketSubmissions><premarketSubmission><submissionNumber>K905263</submissionNumber><supplementNumber>000</supplementNumber></premarketSubmission><premarketSubmission><submissionNumber>K951032</submissionNumber><supplementNumber>000</supplementNumber></premarketSubmission></premarketSubmissions><gmdnTerms><gmdn><gmdnCode>61874</gmdnCode><gmdnPTName>Open-surgery electrosurgical electrode, monopolar, single-use</gmdnPTName><gmdnPTDefinition>An invasive, monopolar, electrical conductor intended to be attached to an appropriate handle/handpiece (not included) to deliver electrosurgical current directly to tissues for cutting/coagulation during an open surgical procedure. It may be available in a variety of forms (e.g., blade, ball, loop, needle, spatula) and requires a patient contact return electrode to complete the circuit. This is a single-use device intended to be used in a sterile condition.</gmdnPTDefinition><implantable>false</implantable><gmdnCodeStatus>Active</gmdnCodeStatus></gmdn></gmdnTerms><productCodes><fdaProductCode><productCode>GEI</productCode><productCodeName>Electrosurgical, Cutting &amp; Coagulation &amp; Accessories</productCodeName></fdaProductCode><fdaProductCode><productCode>HGI</productCode><productCodeName>Electrocautery, Gynecologic (And Accessories)</productCodeName></fdaProductCode></productCodes><deviceSizes/><environmentalConditions/><sterilization><deviceSterile>true</deviceSterile><sterilizationPriorToUse>false</sterilizationPriorToUse><methodTypes/></sterilization></device>