Profile: Medgyn Products Inc manufactures & distributes quality medical supplies, instruments & equipment that satisfy the needs of the obstetrics and gynecological medical professionals. Our aspiration kits are available in 4, 5 and 6 mm cannula sizes, which minimize the possibility of perforation. We are accredited with ISO 9002 certification. Our products are CE marked. Our Endosampler is a unique, sterile disposable curette for sampling the uterine endometrium. It aids in obtaining clearly differentiated endometrial tissue without anesthesia. This instrument is designed to improve the efficiency, convenience and reliability of the endometrial tissue collection & to reduce the physical discomfort of the patient. It provides liberal histologic specimens and is procedurally cost effective.

The company was founded in 1975, has revenues of USD 1-5 Million, has ~60 employees and is ISO 9002, CE certified.

FDA Registration Number: 1450908

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• Angled Biopsy Punch

• Aspirators

• Biopsy Instruments (FDA Code: KNW / 876.1075) A gastroenterology-urology biopsy instrument is a device used to remove, by cutting or aspiration, a specimen of tissue for microscopic examination. This generic type of device includes the biopsy punch, gastrointestinal mechanical biopsy instrument, suction biopsy instrument, gastro-urology biopsy needle and needle set, and nonelectric biopsy forceps. This section does not apply to biopsy instruments that have specialized uses in other medical specialty areas and that are covered by classification regulations in other parts of the device classification regulations.

• Biopsy Punch (FDA Code: FCI / 876.1075)

• Biopsy Punch Forceps

• Biopsy Punch Tray

• Biopsy Punches (FDA Code: FCI / 876.1075)

• Blood Collection Needles

• Bone Curettes

• Cervical Biopsy Punch

• Cervical Dilator

• Cervical Tenaculums

• Circular Dermal Biopsy Punch

• Colposcope and Accessories (FDA Code: HEX / 884.1630) A colposcope is a device designed to permit direct viewing of the tissues of the vagina and cervix by a telescopic system located outside the vagina. It is used to diagnose abnormalities and select areas for biopsy. This generic type of device may include a light source, cables, and component parts.

• Colposcopes

• Colposcopes, Vaginal examination

• Connecting Flexible Aspirating Tube (FDA Code: BYY / 880.6740) A vacuum-powered body fluid suction apparatus is a device used to aspirate, remove, or sample body fluids. The device is powered by an external source of vacuum. This generic type of device includes vacuum regulators, vacuum collection bottles, suction catheters and tips, connecting flexible aspirating tubes, rigid suction tips, specimen traps, noninvasive tubing, and suction regulators (with gauge).

• Cryosurgical Unit (FDA Code: GEH / 878.4350)

• Curettes

• Curettes (FDA Code: HTF / 878.4800) A manual surgical instrument for general use is a nonpowered, hand-held, or hand-manipulated device, either reusable or disposable, intended to be used in various general surgical procedures. The device includes the applicator, clip applier, biopsy brush, manual dermabrasion brush, scrub brush, cannula, ligature carrier, chisel, clamp, contractor, curette, cutter, dissector, elevator, skin graft expander, file, forceps, gouge, instrument guide, needle guide, hammer, hemostat, amputation hook, ligature passing and knot-tying instrument, knife, blood lancet, mallet, disposable or reusable aspiration and injection needle, disposable or reusable suturing needle, osteotome, pliers, rasp, retainer, retractor, saw, scalpel blade, scalpel handle, one-piece scalpel, snare, spatula, stapler, disposable or reusable stripper, stylet, suturing apparatus for the stomach and intestine, measuring tape, and calipers. A surgical instrument that has specialized uses in a specific medical specialty is classified in separate regulations in parts 868 through 892.

• Cytology Cervical Spatula (FDA Code: HHT / 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:

• Dermal Biopsy Punch (FDA Code: FCI / 876.1075)

• Disposable Biopsy Punch

• Disposable Biopsy Punches (FDA Code: FCI / 876.1075)

• Ear Micro Curettes

• Electrosurgery Instruments

• Elliptical Biopsy Punch

• Elliptical Biopsy Punches

• Endometrial Biopsy Equipment

• Fetal Doppler Ultrasound Monitor (FDA Code: MAA / 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.

• General & Plastic Surgery Biopsy Brush (FDA Code: GEE / 878.4800)

• General Diagnostic Supplies

• General Medical Supplies

• General Purpose Electrosurgical Equipment

• General Surgical Instruments

• Graves, Open Side

• Gynaecological Instruments, Uterine Dilators

• Gynecologic Laparoscope and Accessories (FDA Code: HET / 884.1720) A gynecologic laparoscope is a device used to permit direct viewing of the organs within the peritoneum by a telescopic system introduced through the abdominal wall. It is used to perform diagnostic and surgical procedures on the female genital organs. This generic type of device may include: Trocar and cannula, instruments used through an operating channel, scope preheater, light source and cables, and component parts.

• Hygroscopic-Laminaria Cervical Dilator (FDA Code: HDY / 884.4260) A hygroscopicLaminaria cervical dilator is a device designed to dilate (stretch open) the cervical os by cervical insertion of a conical and expansible material made from the root of a seaweed (Laminaria digitata orLaminaria japonica). The device is used to induce abortion.

• Hysteroscope and Accessories (FDA Code: HIH / 884.1690) A hysteroscope is a device used to permit direct viewing of the cervical canal and the uterine cavity by a telescopic system introduced into the uterus through the cervix. It is used to perform diagnostic and surgical procedures other than sterilization. This generic type of device may include obturators and sheaths, instruments used through an operating channel, scope preheaters, light sources and cables, and component parts.

• Long Handle Curettes

• Metal Vaginal Speculum (FDA Code: HDF / 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:

• Micro Axial Curettes

• Oval Biopsy Punch Forceps

• Perinatal Monitoring System (FDA Code: HGM / 884.2740) A perinatal monitoring system is a device used to show graphically the relationship between maternal labor and the fetal heart rate by means of combining and coordinating uterine contraction and fetal heart monitors with appropriate displays of the well-being of the fetus during pregnancy, labor, and delivery. This generic type of device may include any of the devices subject to 884.2600, 884.2640, 884.2660, 884.2675, 884.2700, and 884.2720. This generic type of device may include the following accessories: Central monitoring system and remote repeaters, signal analysis and display equipment, patient and equipment supports, and component parts.

• Pipettors, Pipettes

• Rotating Biopsy Punches

• Straight Uterine Curette w/Regular Tip

• Tenaculums

• Thoracic Curettes