3f3a853b-89f7-40d4-980a-bde4019179aaUpdatePublished42021-01-222017-01-03In Commercial Distribution10818501020529PackageGS10081850102052210In Commercial DistributionBox00818501020522PrimaryGS1Invotec Tympanostomy Tube123-50536622812592INVOTEC INTERNATIONAL, INC.1Invotec Tympanostomy Tube, Shea Parasol, 1.02mm, SiliconefalsefalsefalsefalsefalsetruetruefalsefalsetruefalsefalsefalseLabeling does not contain MRI Safety InformationfalsefalseK90328500033794Tympanostomy tubeA small, hollow cylinder intended to be implanted, by insertion through the tympanic membrane, for ventilation or drainage of the middle ear. Otherwise known as a myringotomy tube, grommet or an aural vent tube, it is made of materials such as polytetrafluoroethylene (PTFE), polyethylene (PE), silicon elastomer, or porous polyethylene. One type, known as the malleus clip tube, attaches to the malleus. Disposable devices associated with implantation may be included with the device, which may be used to implant bilateral tubes.trueActiveETDTube, Tympanostomytruefalse