{"publicDeviceRecordKey":"7557c1a3-e2a7-4cfe-8b60-4ee5dce2f3cc","publicVersionStatus":"Update","deviceRecordStatus":"Published","publicVersionNumber":5,"publicVersionDate":"2019-12-18T00:00:00.000Z","devicePublishDate":"2016-09-23T00:00:00.000Z","deviceCommDistributionEndDate":null,"deviceCommDistributionStatus":"In Commercial Distribution","identifiers":{"identifier":[{"deviceId":"H671DLS1001","deviceIdType":"Package","deviceIdIssuingAgency":"HIBCC","containsDINumber":"H671DLS1000","pkgQuantity":10,"pkgDiscontinueDate":null,"pkgStatus":"In Commercial Distribution","pkgType":"Overpack"},{"deviceId":"H671DLS1000","deviceIdType":"Primary","deviceIdIssuingAgency":"HIBCC","containsDINumber":null,"pkgQuantity":null,"pkgDiscontinueDate":null,"pkgStatus":null,"pkgType":null}]},"brandName":"LETZ","versionModelNumber":"Electrode Sampler #1","catalogNumber":"DLS-100","dunsNumber":"094651270","companyName":"UTAH MEDICAL PRODUCTS, INC.","deviceCount":1,"deviceDescription":"Electrode Sampler #1, Disposable Electrosurgical Loop and Ball Electrodes, Includes 1 ea. DLP-S11, 2 ea. DLP-M11, 1 ea. DLP-W11, 1 ea. DBL-311, \u0026 1 ea. DBL-511","DMExempt":false,"premarketExempt":false,"deviceHCTP":false,"deviceKit":false,"deviceCombinationProduct":false,"singleUse":true,"lotBatch":true,"serialNumber":false,"manufacturingDate":false,"expirationDate":true,"donationIdNumber":false,"labeledContainsNRL":false,"labeledNoNRL":true,"MRISafetyStatus":"Labeling does not contain MRI Safety Information","rx":true,"otc":false,"contacts":{"customerContact":[{"phone":"800-533-4984","phoneExtension":null,"email":"customer@utahmed.com"}]},"premarketSubmissions":{"premarketSubmission":[{"submissionNumber":"K905263","supplementNumber":"000"},{"submissionNumber":"K951032","supplementNumber":"000"}]},"gmdnTerms":{"gmdn":[{"gmdnCode":"61874","gmdnPTName":"Open-surgery electrosurgical electrode, monopolar, single-use","gmdnPTDefinition":"An invasive, monopolar, electrical conductor intended to be attached to an appropriate handle/handpiece (not included) to deliver electrosurgical current directly to tissues for cutting/coagulation during an open surgical procedure. It may be available in a variety of forms (e.g., blade, ball, loop, needle, spatula) and requires a patient contact return electrode to complete the circuit. This is a single-use device intended to be used in a sterile condition.","implantable":false,"gmdnCodeStatus":"Active"}]},"productCodes":{"fdaProductCode":[{"productCode":"GEI","productCodeName":"Electrosurgical, Cutting \u0026 Coagulation \u0026 Accessories"},{"productCode":"HGI","productCodeName":"Electrocautery, Gynecologic (And Accessories)"}]},"deviceSizes":{"deviceSize":[]},"environmentalConditions":{"storageHandling":[]},"sterilization":{"deviceSterile":true,"sterilizationPriorToUse":false,"methodTypes":{"sterilizationMethod":[]}},"xmlns":"http://www.fda.gov/cdrh/gudid","xsi":"http://www.w3.org/2001/XMLSchema-instance","anomaly":null}