US ENDODONTICS, LLC 00859611006471 EndoRing®

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.

NeedleSafe II is a medical safety device that enables single-handed recapping of needles, I.V. catheters and phlebotomy sets. Mounted horizontally or vertically, NeedleSafe II provides vital protection whenever and wherever needed. Examples of service locations include:At every bedsideOn medication cartsInjection traysPhlebotomy traysCritical Care UnitsEndoscopy SuitesPharmacyAnesthesia/SurgeryPathologyEmergency DepartmentPsychiatric wardsNeedleSafe II may be steam autoclaved, gas sterilized, or disinfected by wiping with or soaking in alcohol.

Stainless steel ruler is used during surgery to measure and check measurements such as width, and length.

Combination Package for shipping containing QTY 100 Large OtoSight Speculum Tips (Unit of Use DI #00850013784073) packaged in 5 20-packs (DI#10850013784070) and QTY 100 Standard OtoSight Speculum Tips (Unit of Use DI #00850013784080) packaged in 5 20-packs (DI#10850013784087).

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.

NeedleSafe II is a medical safety device that enables single-handed recapping of needles, I.V. catheters and phlebotomy sets. Mounted horizontally or vertically, NeedleSafe II provides vital protection whenever and wherever needed. Examples of service locations include:At every bedsideOn medication cartsInjection traysPhlebotomy traysCritical Care UnitsEndoscopy SuitesPharmacyAnesthesia/SurgeryPathologyEmergency DepartmentPsychiatric wardsNeedleSafe II may be steam autoclaved, gas sterilized, or disinfected by wiping with or soaking in alcohol.