GALT MEDICAL CORP. CLI-113-15 Elite HV® F Introducer Kit

GE OEC Elite CFD 31cm Flat Detector Super C-Arm - VAS 15 Software. GE OEC Elite CFD C-Arm 31 cm Flat Detector w/ Bumper VAS 15 Vascular Software, SUPER C Motorized C Refurbished, Calibrated, Ready for Use 31 cm CMOS Flat Detector (CFD) - CMOS - Complementary metal-oxide semiconductor detector - DQE(0): 72% - Active amplification inside pixel for ultra-fast electron mobility - Active Matrix: 1548x1524 pixels - Pixel Pitch: 190.0 um - Nominal resolution (at display): 31 cm: 2.7 lp/mm; 21 cm: 2.8 lp/mm; 15 cm: 2.9 lp/mm - Quad-mode magnification: Live Zoom fluidly from 1 to 4X with no change in dose; Fixed try-mode Mag settings: 31cm/21cm/15cm Workstation Display - 13.6 in Live and Reference Image displayed size - 1 to 1 detail imaging chain from CMOS detector to 4K display resolution - Squircle shaped image retains 100% of image when rotated and no cropped or changed view. - 4K, 32" Ultra high definition (UHD) Color Display - Monitor displays two split screens for equivalent view of two 20in displays - 3840x2160 display resolution - 600 cd/m2 maximum brightness - Touchscreen interface with anti-reflection, anti-fingerprint - Easily position monitor to surgical line of sight with display mount on an articulating arm with five movements What's Included: GE OEC Elite CFD C-Arm, Super C; (REF OEC Elite) Qty: 1 GE Beam Limiting Device; (REF 5455288-03) Qty: 1 GE Laser Aiming Device; (REF 5440087) Qty: 1 GE Image Receptor; (REF 5457729-02) Qty: 1 GE Remote User Interface; (REF 5719003-01) Qty: 1 GE Hand Control OEC ELITE; (REF 5819193); Qty; 1 GE Foot Switch; (REF 1482807); Qty: 1 GE Skin Spacer - Squircular; (REF 5436688-01) Qty: 2

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.