Device typeDrug-delivery iontophoresis system, single-use: An assembly of portable devices that may be used as an alternative to injections to transport ionic-solution medication through the movement of ions resulting from an applied electric field, to locally administer the medication transcutaneously. It typically consists of a disposable, battery-powered, current generator that supplies a constant direct current [e.g., 0.5 to 4 milliampere (mA)], a delivery electrode which typically contains a small reservoir of buffering agent and the medication (e.g., a corticosteroid or anaesthetic), a return electrode, and connecting lead wires. This is a single-use device.
FDA categoryTympanostomy tube delivery product with drug
Device ID00840128600009
Catalog numberTULAKIT1
AvailabilityPrescription
Single useYes
MRI safetyLabeling does not contain MRI Safety Information