{"publicDeviceRecordKey":"7bacd11d-3602-4ad7-a14a-df05aa985e14","publicVersionStatus":"Update","deviceRecordStatus":"Published","publicVersionNumber":3,"publicVersionDate":"2018-07-06T00:00:00.000Z","devicePublishDate":"2016-05-24T00:00:00.000Z","deviceCommDistributionEndDate":null,"deviceCommDistributionStatus":"In Commercial Distribution","identifiers":{"identifier":[{"deviceId":"00841019106969","deviceIdType":"Primary","deviceIdIssuingAgency":"GS1","containsDINumber":null,"pkgQuantity":null,"pkgDiscontinueDate":null,"pkgStatus":null,"pkgType":null}]},"brandName":"Kirwan","versionModelNumber":"24-1469EAU","catalogNumber":null,"dunsNumber":"046355210","companyName":"KIRWAN SURGICAL PRODUCTS LLC","deviceCount":1,"deviceDescription":"Non-Stick Bipolar Coagulation Forceps 10\" (25.4cm) Insulated Bayonet, 1mm Tip, Angled Down","DMExempt":false,"premarketExempt":false,"deviceHCTP":false,"deviceKit":false,"deviceCombinationProduct":false,"singleUse":false,"lotBatch":true,"serialNumber":false,"manufacturingDate":true,"expirationDate":false,"donationIdNumber":false,"labeledContainsNRL":false,"labeledNoNRL":true,"MRISafetyStatus":"Labeling does not contain MRI Safety Information","rx":true,"otc":false,"contacts":{"customerContact":[{"phone":"781-834-9500","phoneExtension":null,"email":"kprario@ksp.com"},{"phone":"781-834-9500","phoneExtension":null,"email":"mprario@ksp.com"}]},"premarketSubmissions":{"premarketSubmission":[{"submissionNumber":"K811820","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":"10"},"sizeText":null,"sizeString":"Length: 10 Inch"}]},"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}