<?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>d9147567-5c2f-4726-ac34-46cbaecbfd3d</publicDeviceRecordKey><publicVersionStatus>Update</publicVersionStatus><deviceRecordStatus>Published</deviceRecordStatus><publicVersionNumber>3</publicVersionNumber><publicVersionDate>2024-01-01</publicVersionDate><devicePublishDate>2023-07-08</devicePublishDate><deviceCommDistributionEndDate xsi:nil="true"/><deviceCommDistributionStatus>In Commercial Distribution</deviceCommDistributionStatus><identifiers><identifier><deviceId>B35441</deviceId><deviceIdType>Unit of Use</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><identifier><deviceId>B354OS4R2</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>Reusable Ratchet Handle - Tips 42cm</brandName><versionModelNumber>OS4R</versionModelNumber><catalogNumber xsi:nil="true"/><dunsNumber>047063695</dunsNumber><companyName>ORANGE SURGICAL INSTRUMENTS, LLC</companyName><deviceCount>10</deviceCount><deviceDescription>Reusable Ratchet Handle - Tips 42cm
</deviceDescription><DMExempt>false</DMExempt><premarketExempt>false</premarketExempt><deviceHCTP>false</deviceHCTP><deviceKit>false</deviceKit><deviceCombinationProduct>false</deviceCombinationProduct><singleUse>false</singleUse><lotBatch>false</lotBatch><serialNumber>true</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/><premarketSubmissions><premarketSubmission><submissionNumber>K101733</submissionNumber><supplementNumber>000</supplementNumber></premarketSubmission></premarketSubmissions><gmdnTerms><gmdn><gmdnCode>33596</gmdnCode><gmdnPTName>Endoscopic electrosurgical handpiece/electrode, monopolar, reusable</gmdnPTName><gmdnPTDefinition>An electrosurgical device which consists of a handpiece with mechanical and/or electrical controls, and a monopolar electrode, intended to deliver electrosurgical current from a system generator directly to tissues for cutting/coagulation/ablation during endoscopic (including laparoscopic, arthroscopic) surgery. It includes a long thin electrode connected to the handpiece, and may include a lumen for suction/irrigation; it is available in a variety of forms (e.g., forceps or snare with ring handles, rigid probe with controls) and requires a patient contact return electrode to complete the circuit. This is a reusable device.</gmdnPTDefinition><implantable>false</implantable><gmdnCodeStatus>Active</gmdnCodeStatus></gmdn><gmdn><gmdnCode>61875</gmdnCode><gmdnPTName>Endoscopic electrosurgical electrode, monopolar, single-use</gmdnPTName><gmdnPTDefinition>A sterile, invasive, distal component of an electrosurgical assembly intended to deliver electrosurgical current in a monopolar configuration (i.e., used with a patient contact return electrode) to tissues for cutting/coagulation/ablation during endoscopic (e.g., laparoscopic, arthroscopic) surgery. It is available in a variety of forms (e.g., exchangeable electrode for electrosurgical forceps, rigid electrode, flexible endoscopic probe) which may include a lumen for suction/irrigation. It does not include a handpiece or housing and has no electrical or mechanical controls (e.g., does not include ring-handles); it is not intended for gas-enhanced electrosurgery. This is a single-use device.</gmdnPTDefinition><implantable>false</implantable><gmdnCodeStatus>Active</gmdnCodeStatus></gmdn></gmdnTerms><productCodes><fdaProductCode><productCode>GEI</productCode><productCodeName>Electrosurgical, Cutting &amp; Coagulation &amp; Accessories</productCodeName></fdaProductCode></productCodes><deviceSizes/><environmentalConditions/><sterilization><deviceSterile>false</deviceSterile><sterilizationPriorToUse>true</sterilizationPriorToUse><methodTypes><sterilizationMethod>Peracetic Acid</sterilizationMethod></methodTypes></sterilization></device>