{"publicDeviceRecordKey":"e21d40d2-1d84-427e-8f83-0896014effb4","publicVersionStatus":"Update","deviceRecordStatus":"Published","publicVersionNumber":3,"publicVersionDate":"2025-02-17T00:00:00.000Z","devicePublishDate":"2016-09-22T00:00:00.000Z","deviceCommDistributionEndDate":null,"deviceCommDistributionStatus":"In Commercial Distribution","identifiers":{"identifier":[{"deviceId":"08718375861547","deviceIdType":"Package","deviceIdIssuingAgency":"GS1","containsDINumber":"08718375863442","pkgQuantity":24,"pkgDiscontinueDate":null,"pkgStatus":"In Commercial Distribution","pkgType":"Shelfbox"},{"deviceId":"08718375863442","deviceIdType":"Primary","deviceIdIssuingAgency":"GS1","containsDINumber":null,"pkgQuantity":null,"pkgDiscontinueDate":null,"pkgStatus":null,"pkgType":null}]},"brandName":"Technomed Europe","versionModelNumber":"TE/S50715-001","catalogNumber":null,"dunsNumber":"418415568","companyName":"Technomed Engineering B.V.","deviceCount":1,"deviceDescription":"Disposable Subdermal Needle Electrode, corkscrew, 4 x 6 colors, 1.2m wire","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":true,"otc":false,"contacts":{"customerContact":[{"phone":"+31434086868","phoneExtension":null,"email":"info@technomed.nl"}]},"gmdnTerms":{"gmdn":[{"gmdnCode":"47714","gmdnPTName":"Subdermal needle electrode","gmdnPTDefinition":"A sterile, multi-purpose electrical conductor inserted beneath the dermal layer of a patient's skin to record/monitor electrical activity (biopotentials) for physiological measurements [typically electroencephalography (EEG), electromyography (EMG), and evoked-potential) and often to provide electrical stimulation. It typically consists of thin shaft of stainless steel connected to a lead wire that terminates with a safety connector for attachment to recording/monitoring and stimulation systems. This is a single-use device.","implantable":false,"gmdnCodeStatus":"Active"}]},"productCodes":{"fdaProductCode":[{"productCode":"IKT","productCodeName":"Electrode, Needle, Diagnostic Electromyograph"},{"productCode":"GXZ","productCodeName":"Electrode, Needle"}]},"deviceSizes":{"deviceSize":[{"sizeType":"Needle Gauge","size":{"unit":"Gauge","value":"23"},"sizeText":null,"sizeString":"Needle Gauge: 23 Gauge"},{"sizeType":"Outer Diameter","size":{"unit":"Millimeter","value":"0.6"},"sizeText":null,"sizeString":"Outer Diameter: 0.6 Millimeter"},{"sizeType":"Length","size":{"unit":"Meter","value":"1.2"},"sizeText":null,"sizeString":"Length: 1.2 Meter"}]},"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":[]}}