Z-1241-2019 Class II Terminated

Medivance(R) ARCTIC SUN(R) ARCTICGEL(TM) Pads: Description, Catalog Number a) Intrepid ArcticGel Small Pad Kit, 31705I b) Intrepid ArcticGel Medium Pad Kit, 31707I c) Intrepid ArcticGel Large Pad Kit, 31709I d) Intrepid ArcticGel Universal Pad, 31700I e) ArcticGel Universal Pad, 31700 f) ArcticGel Universal Pad, 4-pack, 3170004 g) ArcticGel X-Small Pad, 31703 h) ArcticGel X-Small Pad, 2-pack, 3170302 i) ArcticGel Small Pad Kit, 31705 j) ArcticGel Small Pad Kit, 2-pack, 3170502 k) ArcticGel Medium Pad Kit, 31707 l) ArcticGel Medium Pad Kit, 2-pack, 3170702 m) ArcticGel Large Pad Kit, 31709 n) ArcticGel Large Pad Kit, 2-pack, 3170902 o) ArcticGel Small Universal Pad Kit, 31810 p) ArcticGel Small Universal Pad,4-pack, 3180104 q) ArcticGel Neonatal Pad Kit, 31802 (international distribution only) r) Intrepid ArcticGel Small Pad Kit, 31705I Product Usage: The Arctic Sun¿ Temperature Management System is a thermal regulating system, indicated for monitoring and controlling patient temperature. ArcticGel Pads are used with the Arctic Sun¿ Temperature Management System to provide a hydrogel layer that ensures contact between the patient s skin and the pad throughout the treatment.

Specific lots of ArcticGel Pads have potential issues which may result in the insufficient adhesion of the hydrogel to the pad.

Catalog Number / lot number a) Intrepid ArcticGel Small Pad Kit, 31705I / NGAXY602 b) Intrepid ArcticGel Medium Pad Kit, 31707I / NGAXY603 c) Intrepid ArcticGel Large Pad Kit, 31709I / NGAXY604 d) Intrepid ArcticGel Universal Pad, 31700I / NGAXY601 e) ArcticGel Universal Pad, 31700 / NGAW3898, NGAW3055, NGAZ3417, NGBP1302, NGBP2293, NGBQ1040 f) ArcticGel Universal Pad, 4-pack, 3170004 / NGAW2916, NGAW3893, NGAZ3735, NGBP2294, NGBQ1021 g) ArcticGel X-Small Pad, 31703 / h) ArcticGel X-Small Pad, 2-pack, 3170302 / NGBP0392, NGBN3519 i) ArcticGel Small Pad Kit, 31705 / NGAW3894, NGAW4510, NGAZ2312, NGAZ3312, NGBN2492, NGBP0513 j) ArcticGel Small Pad Kit, 2-pack, 3170502 / NGAW3900, NGAW3059, NGAY4735, NGAZ0554, NGBP0514, NGBP4515 k) ArcticGel Medium Pad Kit, 31707 / NGBN3536, NGBP0512 l) ArcticGel Medium Pad Kit, 2-pack, 3170702 / NGBN3521 m) ArcticGel Large Pad Kit, 31709 / n) ArcticGel Large Pad Kit, 2-pack, 3170902 / o) ArcticGel Small Universal Pad Kit, 31810 / NGBP1534 p) ArcticGel Small Universal Pad,4-pack, 3180104 / NGBP1533, NGBP2320 q) ArcticGel Neonatal Pad Kit, 31802 (international distribution only) / NGBP3712 r) ArcticGel Neonatal Pad, 2-pack, 3180202 / NGBP0393