<?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>6d546090-ce80-4c61-b4a8-869293481af7</publicDeviceRecordKey><publicVersionStatus>Update</publicVersionStatus><deviceRecordStatus>Published</deviceRecordStatus><publicVersionNumber>8</publicVersionNumber><publicVersionDate>2021-01-08</publicVersionDate><devicePublishDate>2016-08-19</devicePublishDate><deviceCommDistributionEndDate>2018-09-28</deviceCommDistributionEndDate><deviceCommDistributionStatus>Not in Commercial Distribution</deviceCommDistributionStatus><identifiers><identifier><deviceId>B09923009010</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>V.A.T.S. RYDER NEEDLE HOLDER</brandName><versionModelNumber>2300-901</versionModelNumber><catalogNumber xsi:nil="true"/><dunsNumber>040729840</dunsNumber><companyName>SONTEC INSTRUMENTS, INC.</companyName><deviceCount>1</deviceCount><deviceDescription>V.A.T.S. RYDER NEEDLE HOLDER WITH RATCHET TUNGSTEN CARBIDE SERRATED FINE STRAIGHT 
   </deviceDescription><DMExempt>false</DMExempt><premarketExempt>false</premarketExempt><deviceHCTP>false</deviceHCTP><deviceKit>false</deviceKit><deviceCombinationProduct>false</deviceCombinationProduct><singleUse>false</singleUse><lotBatch>true</lotBatch><serialNumber>false</serialNumber><manufacturingDate>false</manufacturingDate><expirationDate>false</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>800-821-7496</phone><phoneExtension xsi:nil="true"/><email>info@sontecinstruments.com</email></customerContact></contacts><premarketSubmissions><premarketSubmission><submissionNumber>K152400</submissionNumber><supplementNumber>000</supplementNumber></premarketSubmission></premarketSubmissions><gmdnTerms><gmdn><gmdnCode>12726</gmdnCode><gmdnPTName>Suturing needle holder, reusable</gmdnPTName><gmdnPTDefinition>A hand-held manual surgical instrument designed to grasp a suture needle when pushing/pulling the needle and attached suture through tissue during suturing. It is typically made of metal and has short serrated jaws at the distal end to provide better grip of the needle. It is available in a wide variety of sizes and designs, such as: 1) a self-retaining, scissors-like design with ring handles at the proximal end; 2) a tweezers-like design with bowed, hinged handles that are operated by squeezing them together; and 3) a heavy-duty pincer-like design. Some types may utilize inserts made of hard materials (e.g., carbide) and include scissor blades. This is a reusable device.</gmdnPTDefinition><implantable>false</implantable><gmdnCodeStatus>Active</gmdnCodeStatus></gmdn></gmdnTerms><productCodes><fdaProductCode><productCode>GCJ</productCode><productCodeName>Laparoscope, General &amp; Plastic Surgery</productCodeName></fdaProductCode></productCodes><deviceSizes><deviceSize><sizeType>Length</sizeType><size unit="Inch" value="11.25"/><sizeText xsi:nil="true"/></deviceSize><deviceSize><sizeType>Device Size Text, specify</sizeType><size unit="" value=""/><sizeText>3mm Tip</sizeText></deviceSize></deviceSizes><environmentalConditions/><sterilization><deviceSterile>false</deviceSterile><sterilizationPriorToUse>true</sterilizationPriorToUse><methodTypes><sterilizationMethod>Dry Heat Sterilization</sterilizationMethod><sterilizationMethod>Moist Heat or Steam Sterilization</sterilizationMethod></methodTypes></sterilization></device>