<?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>c035c794-0a99-41a0-96c1-24bb010674df</publicDeviceRecordKey><publicVersionStatus>New</publicVersionStatus><deviceRecordStatus>Published</deviceRecordStatus><publicVersionNumber>1</publicVersionNumber><publicVersionDate>2023-06-09</publicVersionDate><devicePublishDate>2023-06-01</devicePublishDate><deviceCommDistributionEndDate xsi:nil="true"/><deviceCommDistributionStatus>In Commercial Distribution</deviceCommDistributionStatus><identifiers><identifier><deviceId>26950900961902</deviceId><deviceIdType>Package</deviceIdType><deviceIdIssuingAgency>GS1</deviceIdIssuingAgency><containsDINumber>06950900961908</containsDINumber><pkgQuantity>5</pkgQuantity><pkgDiscontinueDate xsi:nil="true"/><pkgStatus>In Commercial Distribution</pkgStatus><pkgType> box</pkgType></identifier><identifier><deviceId>06950900961908</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>46950900961906</deviceId><deviceIdType>Package</deviceIdType><deviceIdIssuingAgency>GS1</deviceIdIssuingAgency><containsDINumber>06950900961908</containsDINumber><pkgQuantity>200</pkgQuantity><pkgDiscontinueDate xsi:nil="true"/><pkgStatus>In Commercial Distribution</pkgStatus><pkgType>carton</pkgType></identifier></identifiers><brandName>INT or KDL</brandName><versionModelNumber>NIS02</versionModelNumber><catalogNumber xsi:nil="true"/><dunsNumber>420827639</dunsNumber><companyName>Shanghai Kindly Medical Instruments Co., Ltd.</companyName><deviceCount>1</deviceCount><deviceDescription> Interventional radiology percutaneous-access procedure kit.</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>Labeling does not contain MRI Safety Information</MRISafetyStatus><rx>false</rx><otc>false</otc><contacts/><gmdnTerms><gmdn><gmdnCode>60437</gmdnCode><gmdnPTName>Interventional radiology percutaneous-access kit, single-use</gmdnPTName><gmdnPTDefinition>A collection of various instruments/devices (e.g., introducer sheath, dilator, guides, cannula, needle, angiographic catheter) intended to be used for percutaneous body-access to facilitate a radiological image-guided interventional radiology or surgical procedure [e.g., bile duct biopsy, percutaneous transhepatic cholangiogram, non-vascular drainage procedures, ultrasound-guided spinal surgery]. Some types are designed to function as a channel to facilitate the introduction of radiological image guidance devices (e.g., ultrasound probe/transducer) [not included]. It does not contain pharmaceuticals. This is a single-use device.</gmdnPTDefinition><implantable>false</implantable><gmdnCodeStatus>Obsolete</gmdnCodeStatus></gmdn></gmdnTerms><productCodes><fdaProductCode><productCode>DYB</productCode><productCodeName>Introducer, Catheter</productCodeName></fdaProductCode></productCodes><deviceSizes/><environmentalConditions/><sterilization><deviceSterile>true</deviceSterile><sterilizationPriorToUse>false</sterilizationPriorToUse><methodTypes/></sterilization></device>