Profile: The Fazex Co. specializes in offering surgical and dental instruments. Our products include gastroenterologic needle holders, operating room table accessories, surgical hammers, scalpel handle, general & plastic surgery surgical elevators, surgical forceps, uterine elevators, obstetrical forceps and ear speculum holders.

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• Blood Collection Sets with Needle Holder

• Blood Needle Holder Systems

• Coronary Needle Holders

• Cosmetic Surgery, Needle Holder (Serrated)

• Crile Wood Needle Holder

• Curved Carbide Jaw Needle Holder

• Cystoscopic Scissors (FDA Code: KGD / 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.

• Disposable Medical Scissors (FDA Code: JOK / 880.6820) Medical disposable scissors are disposable type general cutting devices intended for medical purposes. This generic type of device does not include surgical scissors.

• Dissecting Scalpel Handle

• Ear Scissors (FDA Code: JZB / 874.4420)

• Ear Speculum Holder (FDA Code: JYK / 878.1800) A speculum is a device intended to be inserted into a body cavity to aid observation. It is either nonilluminated or illuminated and may have various accessories.

• Ear Spoon (FDA Code: JZE / 874.4420)

• Ear Spoon & Hook

• Electronic Stethoscopes (FDA Code: DQD / 870.1875) A manual stethoscope is a mechanical device used to project the sounds associated with the heart, arteries, and veins and other internal organs.

• Forceps (FDA Code: HTD / 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.

• Forceps Needle Holders

• 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.

• General & Plastic Surgery Forceps (FDA Code: GEN / 878.4800)

• General & Plastic Surgery Surgical Elevator (FDA Code: GEG / 878.4800)

• Gynecological Surgical Forceps (FDA Code: HCZ / 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:

• Hexagonal Needle Holder

• Left Hand Needle Holders

• Micro Castroviejo Needle Holder with Stopper

• Micro Needle Holder

• Micro Needle Holder Round Handle

• Micro Needle Holders with Flat Handles

• Micro Needle Holders with Lightweight Plastic Handles

• Micro Spring Handle Needle Holder

• Microvascular Needle Holders

• Nasal Scissors (FDA Code: KBD / 874.4420)

• Nasal Scissors curved

• Nasal Scissors Straight (FDA Code: KBD / 874.4420)

• Needle Holder For 10mm Diameter Tubes

• Needle Holder Round

• Needle Holders & Scissors

• Needle Holders Repair Service

• Needle Holders with TC-Inserts

• Needle Holders with Tungsten Carbide Inserts

• Obstetrical Forceps (FDA Code: HDA / 884.4400) An obstetric forceps is a device consisting of two blades, with handles, designed to grasp and apply traction to the fetal head in the birth passage and facilitate delivery.

• Ophthalmic Forceps (FDA Code: HNR / 886.4350) A manual ophthalmic surgical instrument is a nonpowered, handheld device intended to aid or perform ophthalmic surgical procedures. This generic type of device includes the manual corneal burr, ophthalmic caliper, ophthalmic cannula, eyelid clamp, ophthalmic muscle clamp, iris retractor clip, orbital compressor, ophthalmic curette, cystotome, orbital depressor, lachrymal dilator, erisophake, expressor, ophthalmic forcep, ophthalmic hook, sphere introducer, ophthalmic knife, ophthalmic suturing needle, lachrymal probe, trabeculotomy probe, cornea-sclera punch, ophthalmic retractor, ophthalmic ring (Flieringa), lachrymal sac rongeur, ophthalmic scissors, enucleating snare, ophthalmic spatula, ophthalmic specula, ophthalmic spoon, ophthalmic spud, trabeculotome or ophthalmic manual trephine.

• Ophthalmology Needle Holders

• Orthopedic Elevator (FDA Code: HTE / 878.4800)

• Pediatric Tube Needle Holder Adapter

• Scalpel Handle (FDA Code: GDZ / 878.4800)

• Serrated Jaws Carbide Jaw Needle Holder

• Sharpes Container (FDA Code: MMK / 880.5570) A hypodermic single lumen needle is a device intended to inject fluids into, or withdraw fluids from, parts of the body below the surface of the skin. The device consists of a metal tube that is sharpened at one end and at the other end joined to a female connector (hub) designed to mate with a male connector (nozzle) of a piston syringe or an intravascular administration set.

• Single use VacutainerT Needle Holder

• Single-Use Needle Holder

• Sinus Endoscopy, Nasal Scissors

• Sinus Endoscopy, Needle Holders