{"publicDeviceRecordKey":"2f04a69e-ed50-4be5-82a5-135ce0b357fa","publicVersionStatus":"Update","deviceRecordStatus":"Published","publicVersionNumber":4,"publicVersionDate":"2025-09-04T00:00:00.000Z","devicePublishDate":"2023-04-20T00:00:00.000Z","deviceCommDistributionEndDate":null,"deviceCommDistributionStatus":"In Commercial Distribution","identifiers":{"identifier":[{"deviceId":"SCKITMS5","deviceIdType":"Package","deviceIdIssuingAgency":"HIBCC","containsDINumber":"B006SCKITMS52","pkgQuantity":5,"pkgDiscontinueDate":null,"pkgStatus":"In Commercial Distribution","pkgType":null},{"deviceId":"B006SCKITMS52","deviceIdType":"Primary","deviceIdIssuingAgency":"HIBCC","containsDINumber":null,"pkgQuantity":null,"pkgDiscontinueDate":null,"pkgStatus":null,"pkgType":null},{"deviceId":"B006SCKITMS1","deviceIdType":"Unit of Use","deviceIdIssuingAgency":"HIBCC","containsDINumber":null,"pkgQuantity":null,"pkgDiscontinueDate":null,"pkgStatus":null,"pkgType":null},{"deviceId":"00810155862237","deviceIdType":"Secondary","deviceIdIssuingAgency":"GS1","containsDINumber":null,"pkgQuantity":null,"pkgDiscontinueDate":null,"pkgStatus":null,"pkgType":null}]},"brandName":"Dragonfly®","versionModelNumber":"N/A","catalogNumber":"DSPSCKIT-MS-5","dunsNumber":"182057401","companyName":"Neurovision Medical Products, Inc.","deviceCount":5,"deviceDescription":null,"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":false,"MRISafetyStatus":"Labeling does not contain MRI Safety Information","rx":false,"otc":false,"contacts":{"customerContact":[]},"gmdnTerms":{"gmdn":[{"gmdnCode":"62208","gmdnPTName":"Electromyographic endotracheal tube electrode","gmdnPTDefinition":"A sterile electrical-conducting strip intended to be attached to an endotracheal tube to conduct the electromyographic (EMG) activity of the laryngeal and vocal cord musculature while the tube is in situ. It is used to assess the status of the nerves supplying the laryngeal musculature during surgery. It is intended to be connected to an appropriate EMG measuring/recording device, and may be supplied with a ground electrode. This is a single-use device.","implantable":false,"gmdnCodeStatus":"Active"},{"gmdnCode":"11441","gmdnPTName":"Electromyographic needle electrode, single-use","gmdnPTDefinition":"A sterile electrical conducting device designed to be inserted percutaneously into muscle or nerve tissue to detect bioelectrical signal activity. It is a needle-like device (a needle electrode with an electrical connector at the proximal end) that is connected to an electromyograph (EMG) with a dedicated cable/lead. The EMG records the electrical signals and converts them into a readable graph format; it is not primarily intended for nerve stimulation. This is a single-use device.","implantable":false,"gmdnCodeStatus":"Active"}]},"productCodes":{"fdaProductCode":[{"productCode":"ETN","productCodeName":"Stimulator, Nerve"},{"productCode":"IKT","productCodeName":"Electrode, Needle, Diagnostic Electromyograph"}]},"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,"premarketSubmissions":{"premarketSubmission":[]}}