<?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>44f51512-fb3c-490c-ba99-a972b578715b</publicDeviceRecordKey><publicVersionStatus>Update</publicVersionStatus><deviceRecordStatus>Published</deviceRecordStatus><publicVersionNumber>3</publicVersionNumber><publicVersionDate>2018-07-06</publicVersionDate><devicePublishDate>2015-09-15</devicePublishDate><deviceCommDistributionEndDate xsi:nil="true"/><deviceCommDistributionStatus>In Commercial Distribution</deviceCommDistributionStatus><identifiers><identifier><deviceId>M746SSB650</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>Silicone Silo Bag</brandName><versionModelNumber>SSB65</versionModelNumber><catalogNumber>SSB65</catalogNumber><dunsNumber>002112626</dunsNumber><companyName>SPECIALTY SURGICAL PRODUCTS INC</companyName><deviceCount>1</deviceCount><deviceDescription>Silicone Silo Bag For The Reduction of Abdominal Ventral Wall Defects</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>false</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>888-878-0811</phone><phoneExtension xsi:nil="true"/><email>customerservice@ssp-inc.com</email></customerContact></contacts><premarketSubmissions><premarketSubmission><submissionNumber>K973082</submissionNumber><supplementNumber>000</supplementNumber></premarketSubmission></premarketSubmissions><gmdnTerms><gmdn><gmdnCode>61147</gmdnCode><gmdnPTName>Negative-pressure wound therapy open-abdomen dressing</gmdnPTName><gmdnPTDefinition>A sterile dressing intended to be used on an open abdominal wall wound, with exposed viscera (e.g., abdominal compartment syndrome), to provide temporary wound bridging during negative-pressure wound therapy when primary closure is not possible and/or repeat abdominal entries are necessary. It typically consists of a nonadherent visceral protective layer, a perforated foam layer, an insulation layer to contain negative pressure, and tubing to connect to a negative-pressure wound therapy unit. This is a single-use device.</gmdnPTDefinition><implantable>false</implantable><gmdnCodeStatus>Active</gmdnCodeStatus></gmdn></gmdnTerms><productCodes><fdaProductCode><productCode>FTL</productCode><productCodeName>Mesh, Surgical, Polymeric</productCodeName></fdaProductCode></productCodes><deviceSizes><deviceSize><sizeType>Width</sizeType><size unit="Centimeter" value="6.5"/><sizeText xsi:nil="true"/></deviceSize></deviceSizes><environmentalConditions/><sterilization><deviceSterile>true</deviceSterile><sterilizationPriorToUse>false</sterilizationPriorToUse><methodTypes/></sterilization></device>