<?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>d88d4f4c-edc0-4ed8-ae53-8fc5a32501bd</publicDeviceRecordKey><publicVersionStatus>Update</publicVersionStatus><deviceRecordStatus>Published</deviceRecordStatus><publicVersionNumber>2</publicVersionNumber><publicVersionDate>2026-04-13</publicVersionDate><devicePublishDate>2022-01-14</devicePublishDate><deviceCommDistributionEndDate xsi:nil="true"/><deviceCommDistributionStatus>In Commercial Distribution</deviceCommDistributionStatus><identifiers><identifier><deviceId>10816848024040</deviceId><deviceIdType>Package</deviceIdType><deviceIdIssuingAgency>GS1</deviceIdIssuingAgency><containsDINumber>00816848024043</containsDINumber><pkgQuantity>12</pkgQuantity><pkgDiscontinueDate xsi:nil="true"/><pkgStatus>In Commercial Distribution</pkgStatus><pkgType>Box</pkgType></identifier><identifier><deviceId>00816848024043</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>SUPRAMID EXTRA</brandName><versionModelNumber>Code 2S-1-40B</versionModelNumber><catalogNumber>Code 2S-1-40B</catalogNumber><dunsNumber>069277028</dunsNumber><companyName>S JACKSON INC</companyName><deviceCount>1</deviceCount><deviceDescription>1/4 Circle Spatulated Double-Arm Needle (8mm), USP 4-0 SUPRAMID EXTRA black cable-type Nylon, 12&quot;</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>8003685225</phone><phoneExtension xsi:nil="true"/><email>sales@supramid.com</email></customerContact></contacts><gmdnTerms><gmdn><gmdnCode>37997</gmdnCode><gmdnPTName>Nylon suture, non-bioabsorbable, multifilament, non-antimicrobial</gmdnPTName><gmdnPTDefinition>A multiple-strand (multifilament), synthetic, non-bioabsorbable thread made of nylon (a polyamide polymer) intended to join (i.e., approximate) the edges of a soft-tissue wound or incision by stitching or to ligate soft tissues; it may include an attached disposable device(s) [e.g., needle, passer] intended to facilitate suture application. The thread provides temporary wound support until the wound sufficiently heals to withstand normal stress. 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>GAR</productCode><productCodeName>Suture, Nonabsorbable, Synthetic, Polyamide</productCodeName></fdaProductCode></productCodes><deviceSizes/><environmentalConditions/><sterilization><deviceSterile>true</deviceSterile><sterilizationPriorToUse>false</sterilizationPriorToUse><methodTypes/></sterilization></device>