{"publicDeviceRecordKey":"6f9d8426-8149-471f-b096-eab5de8144b4","publicVersionStatus":"Update","deviceRecordStatus":"Published","publicVersionNumber":7,"publicVersionDate":"2024-03-25T00:00:00.000Z","devicePublishDate":"2016-08-19T00:00:00.000Z","deviceCommDistributionEndDate":"2018-09-28T00:00:00.000Z","deviceCommDistributionStatus":"Not in Commercial Distribution","identifiers":{"identifier":[{"deviceId":"B0994128550","deviceIdType":"Primary","deviceIdIssuingAgency":"HIBCC","containsDINumber":null,"pkgQuantity":null,"pkgDiscontinueDate":null,"pkgStatus":null,"pkgType":null}]},"brandName":"SONTEC NEURO SUCTION","versionModelNumber":"412-855","catalogNumber":null,"dunsNumber":"040729840","companyName":"SONTEC INSTRUMENTS, INC.","deviceCount":1,"deviceDescription":"SONTEC NEURO SUCTION SMALL","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":true,"otc":false,"contacts":{"customerContact":[{"phone":"+1(800)821-7496","phoneExtension":null,"email":"info@sontecinstruments.com"}]},"gmdnTerms":{"gmdn":[{"gmdnCode":"38749","gmdnPTName":"Surgical/emergency suction cannula, non-illuminating, reusable","gmdnPTDefinition":"An atraumatic, invasive, hand-operated, single-lumen, rigid/semi-rigid tube designed as a conduit for aspiration of body cavities, wounds, or surgical sites to facilitate observation and/or to clear an airway obstruction. It is not dedicated to dental, intrauterine, or liposuction procedures, and is neither an ophthalmic nor an intravascular device; it is not designed for surgical irrigation. Sometimes referred to as a suction tube or tip, it may incorporate a handle with side valve(s)/hole(s), and may be provided with a stylet, sheath, and/or connection tubing; it does not include a light source or fibreoptic bundle. This is a reusable device.","implantable":false,"gmdnCodeStatus":"Active"}]},"productCodes":{"fdaProductCode":[{"productCode":"JOL","productCodeName":"Catheter And Tip, Suction"}]},"deviceSizes":{"deviceSize":[{"sizeType":"Device Size Text, specify","size":{"unit":"","value":""},"sizeText":"2.5mm Tip"},{"sizeType":"Device Size Text, specify","size":{"unit":"","value":""},"sizeText":"2.75 Inch Shaft"}]},"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":[]}}