STRAIGHT SMILE LLC BYTERKS Impression Rekit (Small)

The Test of Variables of Attention (T.O.V.A.) kit contains the hardware and software necessary to install and administer the T.O.V.A. continuous performance test. The T.O.V.A. provides healthcare professionals with objective measurements of attention and inhibitory control. The visual T.O.V.A. aids in the assessment of, and evaluation of treatment for, attention deficits, including attention-deficit/hyperactivity disorder (ADHD). The auditory T.O.V.A. aids in the assessment of attention deficits, including ADHD. T.O.V.A. results should only be interpreted by qualified professionals.

Set Includes the following: 242-100-008 : 2.5 mm Grasper 242-100-004 : 2.1 mm Left Blunt Nose Grasper 242-100-005 : 2.1 mm Down Blunt Nose Grasper 242-100-006 : 2.1 mm Up Blunt Nose Grasper 242-100-002 :2.1 mm Straight Blunt Nose Grasper 242-100-012 : 2.7 mm Straight Blunt Nose 242-100-007 : 2.5 mm Championª Scissors 242-100-013 : 2.7 mm Up Blunt Nose

Amplatz Type Renal Dilator/Sheath Set

Burr, Oval, 10 flute, 3.0mm

Biosentry Tract Sealant System

Smart Port CT Low Profile Titanium Port System with Attachable 6.6F x 55cm Polyurethane Catheter and 7F Introducer Kit (Non-Filled Suture Holes)

LARGE EXTERNAL FIXATOR ANKLE FRAME KIT-STERILE

C-MOUNT HIP AR-SCOPE 30°,3.5X 202MM

C-MOUNT HIP AR-SCOPE 70°,3.5X 204MM

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.

The Test of Variables of Attention (T.O.V.A.) kit contains the hardware and software necessary to install and administer the T.O.V.A. continuous performance test. The T.O.V.A. provides healthcare professionals with objective measurements of attention and inhibitory control. The visual T.O.V.A. aids in the assessment of, and evaluation of treatment for, attention deficits, including attention-deficit/hyperactivity disorder (ADHD). The auditory T.O.V.A. aids in the assessment of attention deficits, including ADHD. T.O.V.A. results should only be interpreted by qualified professionals.

Set Includes the following: 242-100-008 : 2.5 mm Grasper 242-100-004 : 2.1 mm Left Blunt Nose Grasper 242-100-005 : 2.1 mm Down Blunt Nose Grasper 242-100-006 : 2.1 mm Up Blunt Nose Grasper 242-100-002 :2.1 mm Straight Blunt Nose Grasper 242-100-012 : 2.7 mm Straight Blunt Nose 242-100-007 : 2.5 mm Championª Scissors 242-100-013 : 2.7 mm Up Blunt Nose

Amplatz Type Renal Dilator/Sheath Set

Burr, Oval, 10 flute, 3.0mm