Profile: Cooper Surgical, Inc. provides medical devices and procedure solutions that improve health care delivery to women regardless of the clinical setting. Our product categories are obstetrics, family planning, general examination, cervical care, incontinence products, surgical and neonatal products. Some of our products are vacuum assist delivery devices, antepartum fetal monitors, fetal dopplers, colposcopy systems, and colposcopy instruments. Our Mityvac® line of obstetrics products are reusable and reposable. Our MityVac® is based on the reusable MityVac® pump, with a variety of disposable cup configurations. The FetalGard Lite®, is a powerful and flexible system for monitoring fetal heart rate & pressure, critical to healthy outcomes for mother &child. The optional remote care through FetalGard Lite® view software, allows communication with the computer network.

The company was founded in 1990, has revenues of USD 100-500 Million, has ~430 employees and is ISO 9001, CE certified. NYSE:COO (SEC Filings)

FDA Registration Number: 1216677

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• Fertility Products, Oil for Tissue Culture

• Fertility Products, Oocyte Retrieval Needle

• Fertility Products, Phosphate Buffered Saline

• Fertility Products, Polyvinylpyrrolidone

• Fertility Products, Serum Protein Substitute

• Fertility Products, Sperm Freezing Medium

• Fertility Products, Sperm Separation Media

• Fertility Products, Sperm Washing Medium

• Fertility Products, Sperm Washing Medium without Antibiotics

• Fertility Products, Trial Transfer Catheter

• Fertility Products, Variable-Speed Centrifuge

• Fertility Products, Water for Tissue Culture

• 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.

• Fetal Monitoring Bands

• Fetal Stethoscope (FDA Code: HGN / 884.2900) A fetal stethoscope is a device used for listening to fetal heart sounds. It is designed to transmit the fetal heart sounds not only through sound channels by air conduction, but also through the user's head by tissue conduction into the user's ears. It does not use ultrasonic energy. This device is designed to eliminate noise interference commonly caused by handling conventional stethoscopes.

• Fetal Vacuum Extractor (FDA Code: HDB / 884.4340) A fetal vacuum extractor is a device used to facilitate delivery. The device enables traction to be applied to the fetal head (in the birth canal) by means of a suction cup attached to the scalp and is powered by an external vacuum source. This generic type of device may include the cup, hosing, vacuum source, and vacuum control.

• Fiberoptic Cables

• Filshie Clip Applicator

• Filshie Clips

• Forceps, Uterine Tenaculum

• Gastroenterologic Needle Holder (FDA Code: FHQ / 876.4730) A manual gastroenterology-urology surgical instrument and accessories is a device designed to be used for gastroenterological and urological surgical procedures. The device may be nonpowered, hand-held, or hand-manipulated. Manual gastroenterology-urology surgical instruments include the biopsy forceps cover, biopsy tray without biopsy instruments, line clamp, nonpowered rectal probe, nonelectrical clamp, colostomy spur-crushers, locking device for intestinal clamp, needle holder, gastro-urology hook, gastro-urology probe and director, nonself-retaining retractor, laparotomy rings, nonelectrical snare, rectal specula, bladder neck spreader, self-retaining retractor, and scoop.

• Gel Warmer

• General & Plastic Surgery Forceps (FDA Code: GEN / 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.

• General & Plastic Surgery Laparoscope (FDA Code: GCJ / 876.1500) An endoscope and accessories is a device used to provide access, illumination, and allow observation or manipulation of body cavities, hollow organs, and canals. The device consists of various rigid or flexible instruments that are inserted into body spaces and may include an optical system for conveying an image to the user's eye and their accessories may assist in gaining access or increase the versatility and augment the capabilities of the devices. Examples of devices that are within this generic type of device include cleaning accessories for endoscopes, photographic accessories for endoscopes, nonpowered anoscopes, binolcular attachments for endoscopes, pocket battery boxes, flexible or rigid choledochoscopes, colonoscopes, diagnostic cystoscopes, cystourethroscopes, enteroscopes, esophagogastroduodenoscopes, rigid esophagoscopes, fiberoptic illuminators for endoscopes, incandescent endoscope lamps, biliary pancreatoscopes, proctoscopes, resectoscopes, nephroscopes, sigmoidoscopes, ureteroscopes, urethroscopes, endomagnetic retrievers, cytology brushes for endoscopes, and lubricating jelly for transurethral surgical instruments. This section does not apply to endoscopes that have specialized uses in other medical specialty areas and that are covered by classification regulations in other parts of the device classification regulations.

• General Manual Obstetric/Gynecologic Instrument (FDA Code: KOH / 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:

• General Purpose Electrosurgical Equipment

• General Surgical Manual Instrument (FDA Code: MDM / 878.4800)

• General Surgical Scissors (FDA Code: LRW / 878.4800)

• General use Surgical Curettes (FDA Code: FZS / 878.4800)

• Gynecologic Cryosurgical Unit

• Gynecologic Electrocautery and Accessories (FDA Code: HGI / 884.4120) A gynecologic electrocautery is a device designed to destroy tissue with high temperatures by tissue contact with an electrically heated probe. It is used to excise cervical lesions, perform biopsies, or treat chronic cervicitis under direct visual observation. This generic type of device may include the following accessories: an electrical generator, a probe, and electrical cables.

• 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.

• Gynecological Biopsy Forceps (FDA Code: HFB / 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:

• Hand-Carried Stretcher (FDA Code: FPP / 880.6900) A hand-carried stretcher is a device consisting of a lightweight frame, or of two poles with a cloth or metal platform, on which a patient can be carried.

• Hydraulic Cystometric Device (FDA Code: FEN / 876.1620) A urodynamics measurement system is a device used to measure volume and pressure in the urinary bladder when it is filled through a catheter with carbon dioxide or water. The device controls the supply of carbon dioxide or water and may also record the electrical activity of the muscles associated with urination. The device system may include transducers, electronic signal conditioning and display equipment, a catheter withdrawal device to enable a urethral pressure profile to be obtained, and special catheters for urethral profilometry and electrodes for electromyography. This generic type of device includes the cystometric gas (carbon dioxide) device, the cystometric hydrualic device, and the electrical recording cystometer, but excludes any device that uses air to fill the bladder.

• Hypoallergenic Skin Barrier

• 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.

• Hysteroscopic Insufflator (FDA Code: HIG / 884.1700) A hysteroscopic insufflator is a device designed to distend the uterus by filling the uterine cavity with a liquid or gas to facilitate viewing with a hysteroscope.

• Incubators

• Infant Nasal CPAP

• Infant Transport Device

• Infant Transport Mattress

• Infection Control Gloves

• Intrauterine Insemination Cannula (FDA Code: MFD / 884.5250) A cervical cap is a flexible cuplike receptacle that fits over the cervix to collect menstrual flow or to aid artificial insemination. This generic type of device is not for contraceptive use.

• Laparoscopic Hernia Repair Clip Applier

• Laparoscopic Instrument Holder, Retainer

• Laparoscopic Retrieval Systems

• Laparoscopic Suture Knot Tying Instrument

• Laparoscopic Suturing Devices

• Large Lateral Wall Retractor