<?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>7f15c705-9826-404d-9baa-804fb3f414ec</publicDeviceRecordKey><publicVersionStatus>New</publicVersionStatus><deviceRecordStatus>Published</deviceRecordStatus><publicVersionNumber>1</publicVersionNumber><publicVersionDate>2022-11-21</publicVersionDate><devicePublishDate>2022-11-13</devicePublishDate><deviceCommDistributionEndDate xsi:nil="true"/><deviceCommDistributionStatus>In Commercial Distribution</deviceCommDistributionStatus><identifiers><identifier><deviceId>00842331167775</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>Novo Surgical Inc. </brandName><versionModelNumber>E8318-22</versionModelNumber><catalogNumber>E8318-22</catalogNumber><dunsNumber>033029433</dunsNumber><companyName>NOVO SURGICAL, INC.</companyName><deviceCount>1</deviceCount><deviceDescription>jennings mouth gag, standard pattern, small, 4 3/8&quot; (11.0 cm) spread</deviceDescription><DMExempt>false</DMExempt><premarketExempt>true</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>false</labeledNoNRL><MRISafetyStatus>Labeling does not contain MRI Safety Information</MRISafetyStatus><rx>true</rx><otc>false</otc><contacts><customerContact><phone>1877-860-6686</phone><phoneExtension xsi:nil="true"/><email>info@novosurgical.com</email></customerContact></contacts><gmdnTerms><gmdn><gmdnCode>13399</gmdnCode><gmdnPTName>Ring cutter</gmdnPTName><gmdnPTDefinition>A manually-operated instrument designed for cutting rings and other jewellery from fingers or other body appendages (e.g., the penis) when difficult to remove by other means. It is typically a scissors-like instrument that brings a serrated cutting wheel blade to bear on a thin support which is slipped beneath the ring or item to be removed; the operator rotates the cutting wheel manually by turning an attached handle. This is a reusable device.</gmdnPTDefinition><implantable>false</implantable><gmdnCodeStatus>Active</gmdnCodeStatus></gmdn></gmdnTerms><productCodes><fdaProductCode><productCode>KBN</productCode><productCodeName>Gag, Mouth</productCodeName></fdaProductCode></productCodes><deviceSizes/><environmentalConditions/><sterilization><deviceSterile>false</deviceSterile><sterilizationPriorToUse>true</sterilizationPriorToUse><methodTypes><sterilizationMethod>Moist Heat or Steam Sterilization</sterilizationMethod></methodTypes></sterilization></device>