Profile: Katena Products, Inc. deals with ophthalmic surgical instrumentation. Our product categories are corneal markers, disposable knives, forceps, lasik instruments, phaco choppers, scissors and spatulas. Our phaco spatula has a 60° offset vertical & horizontal chopper on one end and a 12mm long round spatula with a disc-shaped tip on the opposite end. The K3-2344 model phaco spatula is for use in the right hand, while K3-2345 is for the left hand.

The company was founded in 1975, has revenues of USD 10-25 Million, has ~20 employees and is ISO 13485, CE certified.

FDA Registration Number: 2242450

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• Battery-Powered Corneal Burr (FDA Code: HOG / 886.4070) A powered corneal burr is an AC-powered or battery-powered device that is a motor and drilling tool intended to remove rust rings from the cornea of the eye.

• Corneal Markers

• Corneal Micro-Scissors

• Corneal Scissors

• Corneo-Scleral Punch (FDA Code: HNJ / 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.

• Cystotome (FDA Code: HNY / 886.4350)

• Diamond Knives

• Disposable Aspiration and Injection Needle (FDA Code: GAA / 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.

• Disposable Blades

• Disposable Surgical Instrument (FDA Code: KDC / 878.4800)

• Ear Speculum (FDA Code: EPY / 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.

• Electrosurgical Cutting and Coagulation Device (FDA Code: GEI / 878.4400) An electrosurgical cutting and coagulation device and accessories is a device intended to remove tissue and control bleeding by use of high-frequency electrical current.

• Eye Sphere Implant (FDA Code: HPZ / 886.3320) An eye sphere implant is a device intended to be implanted in the eyeball to occupy space following the removal of the contents of the eyeball with the sclera left intact.

• 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 Clamp (FDA Code: GDJ / 878.4800)

• General & Plastic Surgery Surgical Dissector (FDA Code: GDI / 878.4800)

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

• General & Plastic Surgery Surgical Mallet (FDA Code: GFJ / 878.4800)

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

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

• IOL Manipulator

• Iris Retractor Clip (FDA Code: HOC / 886.4350)

• Lacrimal Dilator (FDA Code: HNW / 886.4350)

• Lacrimal Probes (FDA Code: HNL / 886.4350)

• Lacrimal Sac Rongeur (FDA Code: HNG / 886.4350)

• Manual Corneal Burr (FDA Code: HOF / 886.4350)

• Manual Surgical Chisel (FDA Code: FZO / 878.4800)

• Manual Tonometer (FDA Code: HKY / 886.1930) A tonometer and accessories is a manual device intended to measure intraocular pressure by applying a known force on the globe of the eye and measuring the amount of indentation produced (Schiotz type) or to measure intraocular tension by applanation (applying a small flat disk to the cornea). Accessories for the device may include a tonometer calibrator or a tonograph recording system. The device is intended for use in the diagnosis of glaucoma.

• Non-Invasive Tubing (FDA Code: GAZ / 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).

• Ocular Marker (FDA Code: HMR / 886.4570) An ophthalmic surgical marker is a device intended to mark by use of ink, dye, or indentation the location of ocular or scleral surgical manipulation.

• Ocular Pressure Applicator (FDA Code: LCC / 886.4610) An ocular pressure applicator is a manual device that consists of a sphygmomanometer-type squeeze bulb, a dial indicator, a band, and bellows, intended to apply pressure on the eye in preparation for ophthalmic surgery.

• Ophthalmic Aspiration Cannula (FDA Code: HMX / 886.4350)

• Ophthalmic Caliper (FDA Code: HOE / 886.4350)

• Ophthalmic Cannula (FDA Code: HMX / 886.4350)

• Ophthalmic Conformer (FDA Code: HQN / 886.3130) An ophthalmic conformer is a device usually made of molded plastic intended to be inserted temporarily between the eyeball and eyelid to maintain space in the orbital cavity and prevent closure or adhesions during the healing process following surgery. ]

• Ophthalmic Curette (FDA Code: HNZ / 886.4350)

• Ophthalmic Eye Shield (FDA Code: HOY / 886.4750) An ophthalmic eye shield is a device that consists of a plastic or aluminum eye covering intended to protect the eye or retain dressing materials in place.

• Ophthalmic Eyelid Clamp (FDA Code: HOD / 886.4350)

• Ophthalmic Forceps (FDA Code: HNR / 886.4350)

• Ophthalmic Hook (FDA Code: HNQ / 886.4350)

• Ophthalmic Knife (FDA Code: HNN / 886.4350)

• Ophthalmic Lens Radius Measuring Device (FDA Code: HLF / 886.1430) An ophthalmic contact lens radius measuring device is an AC-powered device that is a microscope and dial gauge intended to measure the radius of a contact lens.

• Ophthalmic Manual Trephine (FDA Code: HRH / 886.4350)

• Ophthalmic Muscle Clamp (FDA Code: HOB / 886.4350)

• Ophthalmic Retractor (FDA Code: HNI / 886.4350)

• Ophthalmic Ring (FDA Code: HNH / 886.4350)

• Ophthalmic Spatula (FDA Code: HND / 886.4350)

• Ophthalmic Speculum (FDA Code: HNC / 886.4350)

• Ophthalmic Sponge (FDA Code: HOZ / 886.4790) An ophthalmic sponge is a device that is an absorbant sponge, pad, or spear made of folded gauze, cotton, cellulose, or other material intended to absorb fluids from the operative field in ophthalmic surgery.