{"publicDeviceRecordKey":"2f78eda9-8587-43a6-8f60-86ca256aa5c4","publicVersionStatus":"Update","deviceRecordStatus":"Published","publicVersionNumber":5,"publicVersionDate":"2025-02-17T00:00:00.000Z","devicePublishDate":"2016-09-22T00:00:00.000Z","deviceCommDistributionEndDate":"2021-12-08T00:00:00.000Z","deviceCommDistributionStatus":"Not in Commercial Distribution","identifiers":{"identifier":[{"deviceId":"08718375862933","deviceIdType":"Primary","deviceIdIssuingAgency":"GS1","containsDINumber":null,"pkgQuantity":null,"pkgDiscontinueDate":null,"pkgStatus":null,"pkgType":null}]},"brandName":"Technomed Europe","versionModelNumber":"TE/S68-012","catalogNumber":null,"dunsNumber":"418415568","companyName":"Technomed Engineering B.V.","deviceCount":1,"deviceDescription":"Reusable Subdermal Needle Electrode Pt/Ir, 1 mm female connector without wire, 6 pieces","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":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":"47710","gmdnPTName":"Electromyographic needle electrode, reusable","gmdnPTDefinition":"An 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 reusable device after sterilization.","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":"27"},"sizeText":null,"sizeString":"Needle Gauge: 27 Gauge"},{"sizeType":"Outer Diameter","size":{"unit":"Millimeter","value":"0.4"},"sizeText":null,"sizeString":"Outer Diameter: 0.4 Millimeter"},{"sizeType":"Length","size":{"unit":"Millimeter","value":"13"},"sizeText":null,"sizeString":"Length: 13 Millimeter"}]},"environmentalConditions":{"storageHandling":[]},"sterilization":{"deviceSterile":false,"sterilizationPriorToUse":true,"methodTypes":{"sterilizationMethod":["Moist Heat or Steam Sterilization","Ethylene Oxide"]}},"xmlns":"http://www.fda.gov/cdrh/gudid","xsi":"http://www.w3.org/2001/XMLSchema-instance","anomaly":null,"premarketSubmissions":{"premarketSubmission":[]}}