<?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>751fd7dd-753a-427d-af06-726914a4200e</publicDeviceRecordKey><publicVersionStatus>Update</publicVersionStatus><deviceRecordStatus>Published</deviceRecordStatus><publicVersionNumber>8</publicVersionNumber><publicVersionDate>2025-07-17</publicVersionDate><devicePublishDate>2015-12-15</devicePublishDate><deviceCommDistributionEndDate>2023-03-14</deviceCommDistributionEndDate><deviceCommDistributionStatus>Not in Commercial Distribution</deviceCommDistributionStatus><identifiers><identifier><deviceId>10705031007239</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>ETHICON</brandName><versionModelNumber>6371339050</versionModelNumber><catalogNumber>6371339050</catalogNumber><dunsNumber>002144145</dunsNumber><companyName>Ethicon Inc.</companyName><deviceCount>1</deviceCount><deviceDescription>EVICEL 5 ML DEVICE</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>false</labeledNoNRL><MRISafetyStatus>Labeling does not contain MRI Safety Information</MRISafetyStatus><rx>true</rx><otc>false</otc><contacts><customerContact><phone>+1(877)384-4266</phone><phoneExtension xsi:nil="true"/><email>xxx@xxx.xxx</email></customerContact></contacts><gmdnTerms><gmdn><gmdnCode>47186</gmdnCode><gmdnPTName>Haematological concentrate/haemostatic agent applicator</gmdnPTName><gmdnPTDefinition>A hand-held, manually-operated device designed to administer, in a liquid or spray form, a haematological concentrate and/or haemostatic agent (e.g., thrombin, platelet concentrate, plant polysaccharide) to a surgical wound, lesion, or graft during surgery (open and/or endoscopic), typically to facilitate haemostasis and healing. It is typically a syringe-/plunger-like, single-channel or dual-channel (for co-administration of two separate agents) device, which may also be designed for connection to a gas pump for spraying. Delivery cannula(s)/tip(s) may be included. This is a single-use device.</gmdnPTDefinition><implantable>false</implantable><gmdnCodeStatus>Active</gmdnCodeStatus></gmdn></gmdnTerms><productCodes><fdaProductCode><productCode>FMF</productCode><productCodeName>Syringe, piston</productCodeName></fdaProductCode></productCodes><deviceSizes/><environmentalConditions/><sterilization><deviceSterile>true</deviceSterile><sterilizationPriorToUse>false</sterilizationPriorToUse><methodTypes/></sterilization></device>