{"publicDeviceRecordKey":"7f15c705-9826-404d-9baa-804fb3f414ec","publicVersionStatus":"New","deviceRecordStatus":"Published","publicVersionNumber":1,"publicVersionDate":"2022-11-21T00:00:00.000Z","devicePublishDate":"2022-11-13T00:00:00.000Z","deviceCommDistributionEndDate":null,"deviceCommDistributionStatus":"In Commercial Distribution","identifiers":{"identifier":[{"deviceId":"00842331167775","deviceIdType":"Primary","deviceIdIssuingAgency":"GS1","containsDINumber":null,"pkgQuantity":null,"pkgDiscontinueDate":null,"pkgStatus":null,"pkgType":null}]},"brandName":"Novo Surgical Inc. ","versionModelNumber":"E8318-22","catalogNumber":"E8318-22","dunsNumber":"033029433","companyName":"NOVO SURGICAL, INC.","deviceCount":1,"deviceDescription":"jennings mouth gag, standard pattern, small, 4 3/8\" (11.0 cm) spread","DMExempt":false,"premarketExempt":true,"deviceHCTP":false,"deviceKit":false,"deviceCombinationProduct":false,"singleUse":true,"lotBatch":true,"serialNumber":false,"manufacturingDate":false,"expirationDate":false,"donationIdNumber":false,"labeledContainsNRL":false,"labeledNoNRL":false,"MRISafetyStatus":"Labeling does not contain MRI Safety Information","rx":true,"otc":false,"contacts":{"customerContact":[{"phone":"1877-860-6686","phoneExtension":null,"email":"info@novosurgical.com"}]},"gmdnTerms":{"gmdn":[{"gmdnCode":"13399","gmdnPTName":"Ring cutter","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.","implantable":false,"gmdnCodeStatus":"Active"}]},"productCodes":{"fdaProductCode":[{"productCode":"KBN","productCodeName":"Gag, Mouth"}]},"deviceSizes":{"deviceSize":[]},"environmentalConditions":{"storageHandling":[]},"sterilization":{"deviceSterile":false,"sterilizationPriorToUse":true,"methodTypes":{"sterilizationMethod":["Moist Heat or Steam Sterilization"]}},"xmlns":"http://www.fda.gov/cdrh/gudid","xsi":"http://www.w3.org/2001/XMLSchema-instance","anomaly":null,"premarketSubmissions":{"premarketSubmission":[]}}