Kapp Surgical Instrument Inc

Model #SC5000-4R, Lot #090710, Expiration Date: 2009-10

General Hospital and Personal Use Devices

1

No

Nationwide Distribution-- including the states of AK, CA, CO, FL, GA, ID, IL, IN, LA, MA, MD, MI, MO, MT, NC, NM, OH, PA, TN, TX, UT, and VA

STRIP T's STERILE ADHESIVE ORGANIZER, Model #SC5000-4R, Lot #090710, 510(k) exempt. One (1) adhesive organizer is packed in a Tyvek pouch and 60 pouches are placed into a 'Shelf Box'. The shelf box is placed into a shipping container. || The Sterile Adhesive Organizer is used to hold tubing or instruments to the drape in surgery.

M/odel # K-9536-N, Lot #08-001, Lot #08-002 & Lot #08-003.

General and Plastic Surgery Devices

2

Yes

Product was distributed to the following states: OH, PA & SC. Product was also shipped to Saudia Arabia.

Bariatric Target Ring (Nitinol) (a thin, circular nitinol ring) Model # K-9536-N, Lot #08-001, Lot #08-002 & Lot #08-003. One ring per plastic pouch, three rings are then placed into a plastic box with lid. This box is then placed into a solid white box. Item is shipped and sold non-sterile. || It is intended to be used to radiographically (with X-Ray) mark the site of the "gastropexy" performed during gastric bypass surgery, thereby making it accessible for future diagnostic, therapeutic and feeding purposes.