BAYER MEDICAL CARE INC. XP 65/115VS MEDRAD® MRXperion Sterile Disposable MRI Kit

Silicone gel applicator (Sterile)

Non-Woven Island Dressing (Sterile)

Ostomy Bag

First Aid Kit Wihout Drug (Content : Adhesive bandages in a variety of different sizes and shapes + Non-adherent sterile Gauze Pad + Cleansing wipe (with alcohol)) This type of convenience kit, as listed in the guidance above, is under enforcement discretion, and does not require a premarket notification (510(k)) to market if it meets all criteria in the guidance.

Scar Sticker (Sterile)

Transparent Film (PU Film, Sterile)

Ostomy Bag (Sterile)

Hydrocolloid Dressing (Sterile)

Silicone gel applicator (Sterile)

Non-Woven Island Dressing (Sterile)

Ostomy Bag

First Aid Kit Wihout Drug (Content : Adhesive bandages in a variety of different sizes and shapes + Non-adherent sterile Gauze Pad + Cleansing wipe (with alcohol)) This type of convenience kit, as listed in the guidance above, is under enforcement discretion, and does not require a premarket notification (510(k)) to market if it meets all criteria in the guidance.