Profile: Cook Group Incorporated focuses on the research and product development in minimally invasive medical device technology for diagnostic & therapeutic procedures. Our wire-guided arndt endobronchial blocker set allows one-lung ventilation using a conventional endotrachael tube and a pediatric fiberoptic bronchoscope. Our central venous catheter sets & trays are used for venous pressure monitoring, blood sampling and administration of drugs & fluids.

The company has ~340 employees and is ISO 9000, CE certified.

FDA Registration Number: 1820334

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• Adapter for Disposable Probes

• Adult Cricothyrotomy Kit

• Alligator Jaw-step Biopsy Forceps

• Amniotic Fluid Sampler (FDA Code: HIO / 884.1550) The amniotic fluid sampler (amniocentesis tray) is a collection of devices used to aspirate amniotic fluid from the amniotic sac via a transabdominal approach. Components of the amniocentesis tray include a disposable 3 inch 20 gauge needle with stylet and a 30 cc. syringe, as well as the various sample collection accessories, such as vials, specimen containers, medium, drapes, etc. The device is used at 16-18 weeks gestation for antepartum diagnosis of certain congenital abnormalities or anytime after 24 weeks gestation when used to assess fetal maturity.

• Amplatz Renal Dilators

• Angiographic Injector

• Angiographic Catheter

• Angiographic Catheter Amplatz Left 1.0

• Angiographic Catheter, Angled Pigtail

• Angiographic Catheter, El Gamal Multipurpose

• Angiographic Catheter, El Gamal Sones

• Angiographic Catheter, Multipurpose El Gamal Curve

• Angiographic Catheter, Pigtail Diagnostic Catheters

• Angiographic Injector and Syringe (FDA Code: DXT / 870.1650) An angiographic injector and syringe is a device that consists of a syringe and a high-pressure injector which are used to inject contrast material into the heart, great vessels, and coronary arteries to study the heart and vessels by x-ray photography.

• Angiographic Needle

• Angiographic Syringe

• Angioplasty Guidewire

• Ansel Modification

• Ansel Modification ANL Curve

• Aorto-Saphenous Vein Ostia Marker (FDA Code: KPK / 878.4650)

• Areolar Connective Tissue Grafts In Pediatric

• Assisted Reproduction Accessory (FDA Code: MQG / 884.6120) Assisted reproduction accessories are a group of devices used during assisted reproduction procedures, in conjunction with assisted reproduction needles and/or assisted reproduction catheters, to aspirate, incubate, infuse, and/or maintain temperature. This generic type of device may include:

• 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 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.

• Automatic Contrast Medium Injector (FDA Code: IZQ / 870.1650)

• Balloon Catheters

• Balloon Retention Type Catheter (FDA Code: EZL / 876.5130) A urological catheter and accessories is a flexible tubular device that is inserted through the urethra and used to pass fluids to or from the urinary tract. This generic type of device includes radiopaque urological catheters, ureteral catheters, urethral catheters, coudecatheters, balloon retention type catheters, straight catheters, upper urinary tract catheters, double lumen female urethrographic catheters, disposable ureteral catheters, male urethrographic catheters, and urological catheter accessories including ureteral catheter stylets, ureteral catheter adapters, ureteral catheter holders, ureteral catheter stylets, ureteral catheterization trays, and the gastro-urological irrigation tray (for urological use).

• Balloon Type Cardiovascular Catheter

• 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.

• Balloon Urethral Dilator Catheters

• Balloon Urethral Dilator Sets

• Balloon Urethral Dilators

• Bile Collection Bag (FDA Code: EXF / 876.5010) A biliary catheter and accessories is a tubular flexible device used for temporary or prolonged drainage of the biliary tract, for splinting of the bile duct during healing, or for preventing stricture of the bile duct. This generic type of device may include a bile collecting bag that is attached to the biliary catheter by a connector and fastened to the patient with a strap.

• Biliary & Pancreatic Procedures, Biopsy Forceps

• Biliary Stone Dislodger (FDA Code: LQR / 876.5010)

• Biliary Stone Retrieval Basket

• Biopsy Forceps

• Biopsy Forceps Excision

• Biopsy Forceps Femoral Approach

• Biopsy Forceps with Rotating Shafts

• Biopsy Forceps with Two Teeth

• Biopsy Forceps, Internal Jugular Approach

• Biopsy Forceps, Internal Jugular Approach 7

• 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 Instruments (FDA Code: KNW / 876.1075)

• Biopsy Needle Kit (FDA Code: FCG / 876.1075)

• Blood Collection Sets with Needle Holder

• Blood Needle Holder Systems

• Bronchoscope Accessories (FDA Code: KTI / 874.4680) A bronchoscope (flexible or rigid) and accessories is a tubular endoscopic device with any of a group of accessory devices which attach to the bronchoscope and is intended to examine or treat the larynx and tracheobronchial tree. It is typically used with a fiberoptic light source and carrier to provide illumination. The device is made of materials such as stainless steel or flexible plastic. This generic type of device includes the rigid ventilating bronchoscope, rigid nonventilating bronchoscope, nonrigid bronchoscope, laryngeal-bronchial telescope, flexible foreign body claw, bronchoscope tubing, flexible biopsy forceps, rigid biopsy curette, flexible biopsy brush, rigid biopsy forceps, flexible biopsy curette, and rigid bronchoscope aspirating tube, but excludes the fiberoptic light source and carrier.