{"publicDeviceRecordKey":"cb71f628-13e0-40b1-b8d2-0fe4e8ad712c","publicVersionStatus":"Update","deviceRecordStatus":"Published","publicVersionNumber":2,"publicVersionDate":"2024-04-17T00:00:00.000Z","devicePublishDate":"2020-04-29T00:00:00.000Z","deviceCommDistributionEndDate":null,"deviceCommDistributionStatus":"In Commercial Distribution","identifiers":{"identifier":[{"deviceId":"B382SD75460","deviceIdType":"Primary","deviceIdIssuingAgency":"HIBCC","containsDINumber":null,"pkgQuantity":null,"pkgDiscontinueDate":null,"pkgStatus":null,"pkgType":null}]},"brandName":"Surgical Direct","versionModelNumber":"SD7546","catalogNumber":"SD7546","dunsNumber":"124367223","companyName":"Surgical Direct, Inc.","deviceCount":1,"deviceDescription":"Stainlesss Steel Patient Plate, Use With SD8201 Connecting Cable\n","DMExempt":false,"premarketExempt":false,"deviceHCTP":false,"deviceKit":false,"deviceCombinationProduct":false,"singleUse":false,"lotBatch":true,"serialNumber":false,"manufacturingDate":false,"expirationDate":false,"donationIdNumber":false,"labeledContainsNRL":false,"labeledNoNRL":false,"MRISafetyStatus":"Labeling does not contain MRI Safety Information","rx":true,"otc":false,"contacts":{"customerContact":[{"phone":"+1 (800) 519-3293","phoneExtension":null,"email":"info@surgicaldirect.com"}]},"premarketSubmissions":{"premarketSubmission":[{"submissionNumber":"K921770","supplementNumber":"000"}]},"gmdnTerms":{"gmdn":[{"gmdnCode":"47487","gmdnPTName":"Electrical-only medical device connection cable, reusable","gmdnPTDefinition":"A non-patient-contact, insulated, electrical cord with a connector (plug) at both ends designed to transmit electrical power and/or signal (data) between medical devices (e.g., to connect a lead, electrical catheter, handpiece, or monitor to a parent device). It is not intended to connect directly to patient-worn electrodes (i.e., it is not a lead), is not intended to connect to the mains (i.e., not a mains power cable), does not generate any type of power and/or signal, and has no additional non-electrical conducting or processing functionality. This is a reusable device.","implantable":false,"gmdnCodeStatus":"Active"}]},"productCodes":{"fdaProductCode":[{"productCode":"GEI","productCodeName":"Electrosurgical, Cutting \u0026 Coagulation \u0026 Accessories"}]},"deviceSizes":{"deviceSize":[]},"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}