{"publicDeviceRecordKey":"df417b5d-9975-4614-8661-1562c8d841ef","publicVersionStatus":"Update","deviceRecordStatus":"Published","publicVersionNumber":6,"publicVersionDate":"2025-10-29T00:00:00.000Z","devicePublishDate":"2016-05-24T00:00:00.000Z","deviceCommDistributionEndDate":null,"deviceCommDistributionStatus":"In Commercial Distribution","identifiers":{"identifier":[{"deviceId":"00887482140291","deviceIdType":"Primary","deviceIdIssuingAgency":"GS1","containsDINumber":null,"pkgQuantity":null,"pkgDiscontinueDate":null,"pkgStatus":null,"pkgType":null}]},"brandName":"Symmetry Malis®","versionModelNumber":"08-0142","catalogNumber":"08-0142","dunsNumber":"027680821","companyName":"ASPEN SURGICAL PRODUCTS, INC.","deviceCount":1,"deviceDescription":"Symmetry® Bipolar Forceps; Hardy Bayonet; Straight; Insulated; Irrigating; 1.0 mm Tips; 7 3/4 in","DMExempt":true,"premarketExempt":false,"deviceHCTP":false,"deviceKit":false,"deviceCombinationProduct":false,"singleUse":false,"lotBatch":true,"serialNumber":false,"manufacturingDate":true,"expirationDate":false,"donationIdNumber":false,"labeledContainsNRL":false,"labeledNoNRL":false,"MRISafetyStatus":"Labeling does not contain MRI Safety Information","rx":true,"otc":false,"contacts":{"customerContact":[{"phone":"+1 888-364-7004","phoneExtension":null,"email":"customerservice@symmetrysurgical.com"}]},"premarketSubmissions":{"premarketSubmission":[{"submissionNumber":"K974594","supplementNumber":"000"}]},"gmdnTerms":{"gmdn":[{"gmdnCode":"47848","gmdnPTName":"Open-surgery electrosurgical handpiece/electrode, bipolar, reusable","gmdnPTDefinition":"A rigid combined electrosurgical handpiece and bipolar electrode, intended to deliver electrosurgical current from a system generator directly to tissues for cutting/coagulation during an open surgical procedure. It is available in a variety of forms (e.g., pen, pistol-shaped forceps, pincer-shaped forceps, scissors) and may also include irrigation, aspiration, lavage and/or surgical plume (smoke) evacuation features to support its primary electrosurgical function. This is a reusable device.","implantable":false,"gmdnCodeStatus":"Active"}]},"productCodes":{"fdaProductCode":[{"productCode":"GEI","productCodeName":"Electrosurgical, Cutting \u0026 Coagulation \u0026 Accessories"}]},"deviceSizes":{"deviceSize":[{"sizeType":"Length","size":{"unit":"Inch","value":"7.75"},"sizeText":null,"sizeString":"Length: 7.75 Inch"},{"sizeType":"Width","size":{"unit":"Millimeter","value":"1"},"sizeText":null,"sizeString":"Width: 1 Millimeter"}]},"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}