PRIMUS

Serial no: 3383 5474 3296 3591 3618 3103 3986 3629 3136 70-4323 5092 3639 3274 2855 3644 4018 70-4347 3939

Radiology Devices

2

No

Worldwide Distribution- US Nationwide in the states: AL, CA, FL, GA, IL, IN, KY, MA, MI, MO, MS, NJ, NY, OH, OK, PA, RI, SC, TN, TX, WI, WV, and WY; and PR. International distribution to Nassau.

MEVATRON M2 / PRIMUS Mid-Energy, Digital Linear Accelerator, Model No. 01940035 || Product Usage: || The intended use of the device is to deliver x-ray radiation for therapeutic treatment of cancer.

Serial no: 2958 3832 3241 3574 3519 3922 3924 3361 4036 3302 70-4185 3949 3547 3657 3622 3731 3565 5153

Radiology Devices

2

No

Worldwide Distribution- US Nationwide in the states: AL, CA, FL, GA, IL, IN, KY, MA, MI, MO, MS, NJ, NY, OH, OK, PA, RI, SC, TN, TX, WI, WV, and WY; and PR. International distribution to Nassau.

PRIMUS HI, Digital Linear Accelerator, Model No. 04504200 || Product Usage: || The intended use of the device is to deliver x-ray radiation for therapeutic treatment of cancer.

Model number BXB35-05-17-120 Lot 1049856 Model number BXB35-06-17-120 Lot 1049864

Gastroenterology-Urology Devices

2

Yes

Only distributed in US to CA, FL, MA, MD, MS, NY, PA, TN, TX, WA, WV

ev3 Primus GPS Biliary Stent System. Balloon Expandable Stent and Delivery System. The stent is made from a 316L stainless steel tube cut into an open lattice design. It is mounted onto a non-compliant balloon catheter. It is deployed and expanded by inflating the balloon.