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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• Ophthalmic Spoon (FDA Code: HNB / 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.

• Ophthalmic Spud (FDA Code: HNA / 886.4350)

• Ophthalmic Suture Scissors (FDA Code: HNF / 886.4350)

• Ophthalmology Needle Holders

• Opthalmic Scissors

• Orbital Depressor (FDA Code: HNX / 886.4350)

• Phaco Chopper

• Punches

• Ruler and Caliper (FDA Code: FTY / 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.

• Scalpel Blade (FDA Code: GES / 878.4800)

• Scalpel Handle (FDA Code: GDZ / 878.4800)

• Sclera Marker (FDA Code: HMQ / 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.

• Soft 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.

• Speculums

• Sphere Introducer (FDA Code: HNP / 886.4350)

• Sterilization Case

• Surgical Instrument Tray (FDA Code: FSM / 878.4800)

• Surgical Marking Pens (FDA Code: HRP / 886.4570)

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

• Surgical Snare (FDA Code: GAE / 878.4800)

• Table Operating Room Accessories (FDA Code: FWZ / 878.4950) A manual operating table and accessories and a manual operating chair and accessories are nonpowered devices, usually with movable components, intended to be used to support a patient during diagnostic examinations or surgical procedures.

• Trabeculotomy Probes (FDA Code: HNK / 886.4350)

• Trephine Blades

• Trephines

• Wire Loop (FDA Code: JYQ / 874.4420)