<?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>17fbd27a-972a-4df8-91c3-f2b2d84041ab</publicDeviceRecordKey><publicVersionStatus>Update</publicVersionStatus><deviceRecordStatus>Published</deviceRecordStatus><publicVersionNumber>2</publicVersionNumber><publicVersionDate>2023-11-06</publicVersionDate><devicePublishDate>2023-10-12</devicePublishDate><deviceCommDistributionEndDate xsi:nil="true"/><deviceCommDistributionStatus>In Commercial Distribution</deviceCommDistributionStatus><identifiers><identifier><deviceId>00817688024255</deviceId><deviceIdType>Package</deviceIdType><deviceIdIssuingAgency>GS1</deviceIdIssuingAgency><containsDINumber>00817688024248</containsDINumber><pkgQuantity>20</pkgQuantity><pkgDiscontinueDate xsi:nil="true"/><pkgStatus>In Commercial Distribution</pkgStatus><pkgType xsi:nil="true"/></identifier><identifier><deviceId>00817688024248</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>Non-Telescopic PenEvac® MaxReveal ™ Diamond Crystal®</brandName><versionModelNumber>ICM-000-0710</versionModelNumber><catalogNumber>ICM-000-0710</catalogNumber><dunsNumber>616182895</dunsNumber><companyName>I.C. MEDICAL, INC.</companyName><deviceCount>1</deviceCount><deviceDescription> Non-Telescopic PenEvac®-ST, MaxReveal ™ Diamond Crystal Blade®, 70mm (2.75in) Non-Stick Blade, 10 Foot Tube, 22mm to 10mm Connector and Holster, Sterile</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>6237800700</phone><phoneExtension xsi:nil="true"/><email>inquiry@icmedical.com</email></customerContact></contacts><gmdnTerms><gmdn><gmdnCode>61869</gmdnCode><gmdnPTName>Open-surgery electrosurgical handpiece/electrode, monopolar, single-use</gmdnPTName><gmdnPTDefinition>A rigid device consisting of combined electrosurgical handpiece and monopolar electrode intended to deliver electrosurgical current from a system generator directly to tissues for cutting/coagulation during an open surgical procedure. It is available in a variety of forms (e.g., pen, pistol-shaped forceps, pincer-shaped forceps, scissors) and may also include irrigation, aspiration, lavage and/or surgical plume (smoke) evacuation features to support its primary electrosurgical function. 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></productCodes><deviceSizes/><environmentalConditions><storageHandling><storageHandlingType>Storage Environment Temperature</storageHandlingType><storageHandlingHigh unit="Degrees Fahrenheit" value="140"/><storageHandlingLow unit="Degrees Fahrenheit" value="0"/><storageHandlingSpecialConditionText xsi:nil="true"/></storageHandling><storageHandling><storageHandlingType>Storage Environment Humidity</storageHandlingType><storageHandlingHigh unit="Percent (%) Relative Humidity" value="85"/><storageHandlingLow unit="Percent (%) Relative Humidity" value="30"/><storageHandlingSpecialConditionText xsi:nil="true"/></storageHandling></environmentalConditions><sterilization><deviceSterile>true</deviceSterile><sterilizationPriorToUse>false</sterilizationPriorToUse><methodTypes/></sterilization></device>