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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• Adhesive Bandages (FDA Code: KGX / 880.5240) A medical adhesive tape or adhesive bandage is a device intended for medical purposes that consists of a strip of fabric material or plastic, coated on one side with an adhesive, and may include a pad of surgical dressing without a disinfectant. The device is used to cover and protect wounds, to hold together the skin edges of a wound, to support an injured part of the body, or to secure objects to the skin.

• Amniotome (FDA Code: HGE / 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:

• Angled Biopsy Punch

• Applicator

• Assisted Reproduction Catheter (FDA Code: MQF / 884.6110) Assisted reproduction catheters are devices used in in vitro fertilization (IVF), gamete intrafallopian transfer (GIFT), or other assisted reproduction procedures to introduce or remove gametes, zygote(s), preembryo(s), and/or embryo(s) into or from the body. This generic type of device may include catheters, cannulae, introducers, dilators, sheaths, stylets, and component parts.

• Assisted Reproduction Devices

• Assisted Reproduction Microtools (FDA Code: MQH / 884.6130) Assisted reproduction microtools are pipettes or other devices used in the laboratory to denude, micromanipulate, hold, or transfer human gametes or embryos for assisted hatching, intracytoplasmic sperm injection (ICSI), or other assisted reproduction methods.

• Assisted Reproduction Needle (FDA Code: MQE / 884.6100) Assisted reproduction needles are devices used in in vitro fertilization (IVF), gamete intrafallopian transfer (GIFT), or other assisted reproduction procedures to obtain gametes from the body or introduce gametes, zygote(s), preembryo(s) and/or embryo(s) into the body. This generic type of device may include a single or double lumen needle and component parts, including needle guides, such as those used with ultrasound.

• Assisted Reproduction Water Purification System (FDA Code: MTW / 884.6170) Assisted reproduction water purification systems are devices specifically intended to generate high quality, sterile, pyrogen-free water for reconstitution of media used for aspiration, incubation, transfer or storage of gametes or embryos for in vitro fertilization (IVF) or other assisted reproduction procedures. These devices may also be intended as the final rinse for labware or other assisted reproduction devices that will contact the gametes or embryos. These devices also include bottled water ready for reconstitution available from a vendor that is specifically intended for reconstitution of media used for aspiration, incubation, transfer, or storage of gametes or embryos for IVF or other assisted reproduction procedures.

• Balloon Type Catheter (FDA Code: GBA / 878.4200) An introduction/drainage catheter is a device that is a flexible single or multilumen tube intended to be used to introduce nondrug fluids into body cavities other than blood vessels, drain fluids from body cavities, or evaluate certain physiologic conditions. Examples include irrigation and drainage catheters, pediatric catheters, peritoneal catheters (including dialysis), and other general surgical catheters. An introduction/drainage catheter accessory is intended to aid in the manipulation of or insertion of the device into the body. Examples of accessories include adaptors, connectors, and catheter needles.

• Battery-Powered Medical Examination Light (FDA Code: KYT / 880.6350) A battery-powered medical examination light is a battery-powered device intended for medical purposes that is used to illuminate body surfaces and cavities during a medical examination.

• Biopsy Punches (FDA Code: FCI / 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.

• Blunt Dilator

• Bone Clamp (FDA Code: HXD / 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.

• Bone Densitometer (FDA Code: KGI / 892.1170) A bone densitometer is a device intended for medical purposes to measure bone density and mineral content by x-ray or gamma ray transmission measurements through the bone and adjacent tissues. This generic type of device may include signal analysis and display equipment, patient and equipment supports, component parts, and accessories.

• Bone Densitometry System

• Bone Sonometer (FDA Code: MUA / 892.1180)

• Breathing Tube Support (FDA Code: JAY / 868.5280) A breathing tube support is a device that is intended to support and anchor a patient's breathing tube(s).

• Cancer Screening, Breast Aspiration Biopsy Needle

• Cancer Screening, Endometrial Suction Curettes

• Cardiovascular Cryosurgery Unit

• Catheter Accessories (FDA Code: KGZ / 878.4200)

• Cervical Caps (FDA Code: HDR / 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.

• Chemical Heat Pack (FDA Code: MPO / 890.5710) A hot or cold disposable pack is a device intended for medical purposes that consists of a sealed plastic bag incorporating chemicals that, upon activation, provides hot or cold therapy for body surfaces.

• 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.

• Colposcope, Image Documentation Systems

• Colposcopes

• 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).

• Continuous Electronic Thermometer (FDA Code: FLL / 880.2910) A clinical electronic thermometer is a device used to measure the body temperature of a patient by means of a transducer coupled with an electronic signal amplification, conditioning, and display unit. The transducer may be in a detachable probe with or without a disposable cover.

• Contraceptive Diaphragm and Accessories (FDA Code: HDW / 884.5350) A contraceptive diaphragm is a closely fitting membrane placed between the posterior aspect of the pubic bone and the posterior vaginal fornix. The device covers the cervix completely and is used with a spermicide to prevent pregnancy. This generic type of device may include an introducer.

• Contraceptive Tubal Occlusion Device (FDA Code: KNH / 884.5380) A contraceptive tubal occlusion device (TOD) and introducer is a device designed to close a fallopian tube with a mechanical structure, e.g., a band or clip on the outside of the fallopian tube or a plug or valve on the inside. The devices are used to prevent pregnancy.

• Cryogenic Surgical Device (FDA Code: GXH / 882.4250) A cryogenic surgical device is a device used to destroy nervous tissue or produce lesions in nervous tissue by the application of extreme cold to the selected site.

• Cryosurgery, Cone Trichiasis Probe

• Cryosurgery, Curved Cataract Probe

• Cryosurgery, Curved Glaucoma Probe

• Cryosurgery, Curved Hammerhead Retinal Probe

• Cryosurgery, Curved Pediatric Retinal Probe

• Cryosurgery, Curved Retinal Probe

• Cryosurgery, Hammerhead Pediatric Retinal Probe

• Cryosurgery, Micro Curved Cataract Probe

• Cryosurgery, Pediatric Retinal Probe

• Cryosurgery, Posterior Retinal Probe

• Cryosurgery, Spherical Pediatric Retinal Probe

• Cryosurgery, Spherical Retinal Probe

• Cryosurgery, Straight Cataract Probe

• Cryosurgery, Straight Glaucoma Probe

• Cryosurgery, Straight Hammerhead Retinal Probe

• Cryosurgery, Straight Retinal Probe

• Cryosurgery, Trichiasis Probes

• Cryosurgery, Vitreous Intraocular Probe