<?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>fbac3a23-0609-459f-8978-bdf28019d132</publicDeviceRecordKey><publicVersionStatus>Update</publicVersionStatus><deviceRecordStatus>Published</deviceRecordStatus><publicVersionNumber>13</publicVersionNumber><publicVersionDate>2026-03-27</publicVersionDate><devicePublishDate>2015-08-19</devicePublishDate><deviceCommDistributionEndDate>2025-11-30</deviceCommDistributionEndDate><deviceCommDistributionStatus>Not in Commercial Distribution</deviceCommDistributionStatus><identifiers><identifier><deviceId>04046963496784</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>04045439044177</deviceId><deviceIdType>Unit of Use</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>Monoplus</brandName><versionModelNumber>G0024458</versionModelNumber><catalogNumber>G0024458</catalogNumber><dunsNumber>511268005</dunsNumber><companyName>B BRAUN SURGICAL SA</companyName><deviceCount>12</deviceCount><deviceDescription>MONOPLUS VIOLET 1 (4) 90CM HR40 (M)</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(800)282-9000</phone><phoneExtension xsi:nil="true"/><email>GUDID.BBMUS_Service@bbraun.com</email></customerContact></contacts><gmdnTerms><gmdn><gmdnCode>16584</gmdnCode><gmdnPTName>Polyester suture, bioabsorbable, monofilament, non-antimicrobial</gmdnPTName><gmdnPTDefinition>A single-strand (monofilament), synthetic, bioabsorbable thread made from a polyester (e.g., polydioxanone, poliglecaprone, polycaprolactone, polyglyconate, polyhydroxybutyrate) intended to join (approximate) the edges of a soft-tissue wound or incision by stitching or to ligate soft tissues. The thread provides extended temporary wound support, until the wound sufficiently heals to withstand normal stress, and is subsequently absorbed by hydrolysis; it may include an attached disposable device(s) [e.g., needle, passer] intended to facilitate suture application. It is not a barbed suture and does not include antimicrobial agents/materials. This is a single-use device.</gmdnPTDefinition><implantable>true</implantable><gmdnCodeStatus>Active</gmdnCodeStatus></gmdn></gmdnTerms><productCodes><fdaProductCode><productCode>NEW</productCode><productCodeName>SUTURE, SURGICAL, ABSORBABLE, POLYDIOXANONE</productCodeName></fdaProductCode></productCodes><deviceSizes><deviceSize><sizeType>Device Size Text, specify</sizeType><size unit="" value=""/><sizeText>Thread Material : polydioxanone</sizeText></deviceSize><deviceSize><sizeType>Length</sizeType><size unit="Centimeter" value="90.00"/><sizeText xsi:nil="true"/></deviceSize><deviceSize><sizeType>Device Size Text, specify</sizeType><size unit="" value=""/><sizeText>Size of Thread (USP - Others) : 1</sizeText></deviceSize></deviceSizes><environmentalConditions/><sterilization><deviceSterile>true</deviceSterile><sterilizationPriorToUse>false</sterilizationPriorToUse><methodTypes/></sterilization></device>