PROTECH PROFESSIONAL PRODUCTS INC RUC11A ProTech UBAR

The NeoCoil Wireless Audio System is intended to provide entertainment and facilitate communications between the patient and the operator in a Magnetic Resonance Imaging (MRI) scanner environment. The Wireless Audio System is intended to be used by healthcare professionals.The NeoCoil Wireless Audio System is a modular system comprised of wireless patient headphones, a remote audio data source unit, and communications infrastructure.

The IontoPatch contains an innovative self-contained battery that produces an electric current to carry drug molecules non-invasively across the skin and to underlying tissue. There is no need for an external power source. Drug delivery is shut off automatically when the prescribed dosage has been administered. The IontoPatch is single use and disposable. Since there are no external batteries or wires, patients are able to return to their daily activities wearing the patch and receiving time-released iontophoresis.

MedentiBASE Laboratory implant

The AnovoTM Surgical System is a robotic-assisted device intended for use by laparoscopic trained physicians for endoscopic manipulation of tissue, using graspers and electrosurgery devices during single-site laparoscopic gynecologic procedures such as benign hysterectomy and salpingo-oophorectomy through a transvaginal access point. The system composed of Anovo Surgeon Console, two sterile instruments (Anovo Instrument ARMS), bed-mounted Robotic Control Unit (RCU) and Anovo System Accessories [Unit cables, Sterile Drapes, Robotic Control Unit Support System (RCUSS) and Vaginal Access Kit]. Anovo Surgeon Console (UDI # 07290018151013) packed with its power cable (UDI # 07290018151037), Robotic Control Unit (RCU) (UDI # 07290018151044) and Unit Cables (UDI # 07290018151051)

Smart Port CT Single Titanium Port System with Attachable 8.0F x 66cm Polyurethane Catheter and 8 F Introducer Kit (with Valved Introducer and Non-Filled Suture Holes)

Tinted Glow Powder

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.

Cholesterol Panel Test Kit for the quantitative determination of total cholesterol, HDL, LDL, and triglycerides. Results used in the diagnosis and treatment of disorders involving excess cholesterol in the blood.

This kit contains two (2) devices: 1) IontoPatch: Primary DI Number, 108156110200122) Saline: Primary DI Number, 04026704396047The IontoPatch is single use and disposable. The patch is used in conjunction with the saline.

The NeoCoil Wireless Audio System is intended to provide entertainment and facilitate communications between the patient and the operator in a Magnetic Resonance Imaging (MRI) scanner environment. The Wireless Audio System is intended to be used by healthcare professionals.The NeoCoil Wireless Audio System is a modular system comprised of wireless patient headphones, a remote audio data source unit, and communications infrastructure.

The IontoPatch contains an innovative self-contained battery that produces an electric current to carry drug molecules non-invasively across the skin and to underlying tissue. There is no need for an external power source. Drug delivery is shut off automatically when the prescribed dosage has been administered. The IontoPatch is single use and disposable. Since there are no external batteries or wires, patients are able to return to their daily activities wearing the patch and receiving time-released iontophoresis.

MedentiBASE Laboratory implant

The AnovoTM Surgical System is a robotic-assisted device intended for use by laparoscopic trained physicians for endoscopic manipulation of tissue, using graspers and electrosurgery devices during single-site laparoscopic gynecologic procedures such as benign hysterectomy and salpingo-oophorectomy through a transvaginal access point. The system composed of Anovo Surgeon Console, two sterile instruments (Anovo Instrument ARMS), bed-mounted Robotic Control Unit (RCU) and Anovo System Accessories [Unit cables, Sterile Drapes, Robotic Control Unit Support System (RCUSS) and Vaginal Access Kit]. Anovo Surgeon Console (UDI # 07290018151013) packed with its power cable (UDI # 07290018151037), Robotic Control Unit (RCU) (UDI # 07290018151044) and Unit Cables (UDI # 07290018151051)