Info

Rusin Medical Devices, LLC is the developer of the SafeTouchÔ marker sheet. This patented, FDA reviewed unclassified device is intended to be used for marking the location of breast lump(s) that have been identified or suspected during breast examinations. The SafeTouchÔ device consists of a plastic sheet preprinted with a center circle for orientation and a radio-opaque numbered grid for breast lump localization. The underside of the device has areas of light adhesive to anchor the sheet while in use. The marker sheet is used to mark or report the position of suspected breast lump(s) to assist another physician or care provider in relocating a lump, for further evaluation. The SafeTouchÔ device is meant to assist in the marking and relocating of suspected breast lumps by health care providers in a clinical setting or consumers in the privacy of their own home. This device is not intended to be a do-it-yourself aid for personal breast examination, nor a breast examination device. This medical device makes no explicit or implied claim to find breast cancer, breast lumps, or any other breast disease.