{"publicDeviceRecordKey":"c46c4787-74e1-45cc-a5ec-4755059792b1","publicVersionStatus":"Update","deviceRecordStatus":"Published","publicVersionNumber":8,"publicVersionDate":"2021-05-10T00:00:00.000Z","devicePublishDate":"2016-08-26T00:00:00.000Z","deviceCommDistributionEndDate":"2018-09-22T00:00:00.000Z","deviceCommDistributionStatus":"Not in Commercial Distribution","identifiers":{"identifier":[{"deviceId":"B09928005140","deviceIdType":"Primary","deviceIdIssuingAgency":"HIBCC","containsDINumber":null,"pkgQuantity":null,"pkgDiscontinueDate":null,"pkgStatus":null,"pkgType":null}]},"brandName":" INTRODUCER SHAFT","versionModelNumber":"2800-514","catalogNumber":null,"dunsNumber":"040729840","companyName":"SONTEC INSTRUMENTS, INC.","deviceCount":1,"deviceDescription":"HEARTLINE INTRODUCER SHAFT\n   ","DMExempt":false,"premarketExempt":true,"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":false,"otc":false,"contacts":{"customerContact":[{"phone":"800-821-7496","phoneExtension":null,"email":"info@sontecinstruments.com"}]},"gmdnTerms":{"gmdn":[{"gmdnCode":"46774","gmdnPTName":"Surgical retractor/retraction system blade, reusable","gmdnPTDefinition":"A distal component of a surgical retraction system, surgical retractor, and/or surgical instrument assist arm system designed to function as a parting edge to separate the margins of a wound/incision during a surgical procedure. It is intended to be attached to the frame (e.g., mounting ring/bar) of a surgical retraction system, or may be fixed onto a retractor handle; it does not include a handle. It is a metal device, sometimes referred to as a variable or vario retractor blade when assembled with a separate retractor handle, because it is available in a variety of lengths and sizes. This is a reusable device.","implantable":false,"gmdnCodeStatus":"Active"}]},"productCodes":{"fdaProductCode":[{"productCode":"FFO","productCodeName":"Retractor, Self-Retaining"}]},"deviceSizes":{"deviceSize":[{"sizeType":"Length","size":{"unit":"Inch","value":"6.25"},"sizeText":null,"sizeString":"Length: 6.25 Inch"}]},"environmentalConditions":{"storageHandling":[]},"sterilization":{"deviceSterile":false,"sterilizationPriorToUse":true,"methodTypes":{"sterilizationMethod":["Dry Heat Sterilization","Moist Heat or Steam Sterilization"]}},"xmlns":"http://www.fda.gov/cdrh/gudid","xsi":"http://www.w3.org/2001/XMLSchema-instance","anomaly":null,"premarketSubmissions":{"premarketSubmission":[]}}