Profile: Gynex Corporation specializes in providing OB/GYN instruments and equipment to customers worldwide. We offer anesthetic, biopsy punches, clamps, cleaning supplies, colposcopes, curettes, dilators, fetal dopplers, filters, forceps, manipulator, microscopes, and specula. Our Accu-Sound™ uterine sound provides an accurate measurement of uterine depth with no guess work. A ring around the sound comes to rest against the Os when the Accu-Sound™ Uterine Sound is inserted into the uterus. The ring stays in place when the Accu-Sound™ Uterine Sound is withdrawn, clearly indicating the uterine measurement. It is tapered for easy insertion and dilation. The tip is rounded to help prevent accidental perforation. Curved handle fits snuggly in the palm of the hand. Thumb tread provides a secure grip. Our 3mm diameter ball electrode is presented in sterile pack. It is ideal for hemostasis Of bleeding sites and/or ablation Of sub-surface lesional tissues. Our Century™ uterine manipulator/injector is available in sterile pack for single-use,Its flexible plastic insertion sleeve prevents Luer fitting cracks, pear-shaped balloon for optimal hold, incorporated cervical stop, and reduced cannula to allow for easy insertion.

FDA Registration Number: 3032109

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• Ultrasonic Blood Flow Monitor (FDA Code: HEP / 884.2660) A fetal ultrasonic monitor is a device designed to transmit and receive ultrasonic energy into and from the pregnant woman, usually by means of continuous wave (doppler) echoscopy. The device is used to represent some physiological condition or characteristic in a measured value over a period of time (e.g., perinatal monitoring during labor) or in an immediately perceptible form (e.g., use of the ultrasonic stethoscope). This generic type of device may include the following accessories: signal analysis and display equipment, electronic interfaces for other equipment, patient and equipment supports, and component parts. This generic type of device does not include devices used to image some relatively unchanging physiological structure or interpret a physiological condition, but does include devices which may be set to alarm automatically at a predetermined threshold value.

• Ultrasonic Fetal Monitor (FDA Code: KNG / 884.2660)

• Uterine Curettes (FDA Code: HCY / 884.4530) An obstetric-gynecologic specialized manual instrument is one of a group of devices used during obstetric-gynecologic procedures to perform manipulative diagnostic and surgical functions (e.g., dilating, grasping, measuring, and scraping), where structural integrity is the chief criterion of device performance. This type of device consists of the following:

• Uterine Manipulator Injector

• Uterine Manipulator/Injector Cannula (FDA Code: LKF / 884.4530)

• Uterine Manipulators

• Uterine Sounds (FDA Code: HHM / 884.4530)

• Uterine Tenaculum (FDA Code: HDC / 884.4530)

• Vacuum Abortion System (FDA Code: HHI / 884.5070) A vacuum abortion system is a device designed to aspirate transcervically the products of conception or menstruation from the uterus by using a cannula connected to a suction source. This device is used for pregnancy termination or menstrual regulation. This type of device may include aspiration cannula, vacuum source, and vacuum controller.

• Vaginal Pessary (FDA Code: HHW / 884.3575) A vaginal pessary is a removable structure placed in the vagina to support the pelvic organs and is used to treat conditions such as uterine prolapse (falling down of uterus), uterine retroposition (backward displacement), or gynecologic hernia.

• Vaginal Retractors (FDA Code: HDL / 884.4520) An obstetric-gynecologic general manual instrument is one of a group of devices used to perform simple obstetric and gynecologic manipulative functions. This generic type of device consists of the following:

• Vaginal Specula

• Vaginal Stent (FDA Code: KXP / 884.3900) A vaginal stent is a device used to enlarge the vagina by stretching, or to support the vagina and to hold a skin graft after reconstructive surgery.