INTEGRA LIFESCIENCES CORPORATION 41A1416 MAYFIELD®

The NeoCoil Wireless Audio System is intended to provide entertainment and facilitate communications between the patient and the operator in a Magnetic Resonance Imaging (MRI) scanner environment. The Wireless Audio System is intended to be used by healthcare professionals.The NeoCoil Wireless Audio System is a modular system comprised of wireless patient headphones, a remote audio data source unit, and communications infrastructure.

This kit contains two (2) devices: 1) IontoPatch: Primary DI Number, 108156110200122) Saline: Primary DI Number, 04026704396047The IontoPatch is single use and disposable. The patch is used in conjunction with the saline.

The IontoPatch contains an innovative self-contained battery that produces an electric current to carry drug molecules non-invasively across the skin and to underlying tissue. There is no need for an external power source. Drug delivery is shut off automatically when the prescribed dosage has been administered. The IontoPatch is single use and disposable. Since there are no external batteries or wires, patients are able to return to their daily activities wearing the patch and receiving time-released iontophoresis.