Profile: Accutome, Inc manufactures & distributes surgical instruments. Our products include accutome Rx, accutome ultrasound, instruments, disposables, diamond knives, and suggested sets. Our instruments include cannula, cleaning systems, corneal knives, capsule polishers, scrapers, curettes, depressors, choppers, dilators, forceps, speculums, vitreous, and punches. The new B-Probe ultrasound links directly to a laptop or PC computer by USB port. This technology also creates sharper, more focused images due to the elimination of signal loss, which occurs from older tabletop units. The 15 micron resolution is the highest in the medical industry. Our new accupach v has digital signal analysis, which offers accuracy & repeatability. The built in IOP conversion makes calculating IOP quick and easy. Our ultrasonic cleaner consists of durable aluminum cabinet & solid stainless steel tank with rolled edges to prevent leaks.

FDA Registration Number: 2521877

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• Manual Perimeter (FDA Code: HON / 886.1605) A perimeter is an AC-powered or manual device intended to determine the extent of the peripheral visual field of a patient. The device projects light on various points of a curved surface, and the patient indicates whether he or she sees the light.

• Measuring Gauge (FDA Code: JYJ / 874.4420)

• Medical Probes (FDA Code: HXB / 888.4540) An orthopedic manual surgical instrument is a nonpowered hand-held device intended for medical purposes to manipulate tissue, or for use with other devices in orthopedic surgery. This generic type of device includes the cerclage applier, awl, bender, drill brace, broach, burr, corkscrew, countersink, pin crimper, wire cutter, prosthesis driver, extractor, file, fork, needle holder, impactor, bending or contouring instrument, compression instrument, passer, socket positioner, probe, femoral neck punch, socket pusher, reamer, rongeur, scissors, screwdriver, bone skid, staple driver, bone screw starter, surgical stripper, tamp, bone tap, trephine, wire twister, and wrench.

• 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 Ophthalmic Scissors

• Micro Spring Handle Needle Holder

• Microsurgical Instruments (FDA Code: GZX / 882.4525) A microsurgical instrument is a nonpowered surgical instrument used in neurological microsurgery procedures.

• Microvascular Needle Holders

• Mini Sterilization Trays

• 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

• 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.

• Ophthalmic AC-Powered Operating Microscope and Accessories (FDA Code: HRM / 878.4700) A surgical microscope and accessories is an AC-powered device intended for use during surgery to provide a magnified view of the surgical field.

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

• Ophthalmic Cannula (FDA Code: HMX / 886.4350)

• Ophthalmic Curette (FDA Code: HNZ / 886.4350)

• Ophthalmic Forceps (FDA Code: HNR / 886.4350)

• Ophthalmic Hook (FDA Code: HNQ / 886.4350)

• Ophthalmic Knife (FDA Code: HNN / 886.4350)

• Ophthalmic Ring (FDA Code: HNH / 886.4350)

• Ophthalmic Spatula (FDA Code: HND / 886.4350)

• Ophthalmic Speculum (FDA Code: HNC / 886.4350)

• Ophthalmic Spoon (FDA Code: HNB / 886.4350)

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

• Ophthalmology Needle Holders

• Ophthalmology, Surgical Instrument Trays

• Orbital Depressor (FDA Code: HNX / 886.4350)

• Orthopedic Implant, K Nail Measuring Gauge

• Pachymeters (Pachometers), Ultrasonic Pachymetry

• Pediatric Tube Needle Holder Adapter

• Periodontal Probes

• Polyamide Synthetic Non-Absorbable Suture (FDA Code: GAR / 878.5020) Nonabsorbable polyamide surgical suture is a nonabsorbable, sterile, flexible thread prepared from long-chain aliphatic polymers Nylon 6 and Nylon 6,6 and is indicated for use in soft tissue approximation. The polyamide surgical suture meets United States Pharmacopeia (U.S.P.) requirements as described in the U.S.P. monograph for nonabsorbable surgical sutures; it may be monofilament or multifilament in form; it may be provided uncoated or coated; and it may be undyed or dyed with an appropriate FDA listed color additive. Also, the suture may be provided with or without a standard needle attached.

• Polyethylene Synthetic Non-Absorbable Suture (FDA Code: GAT / 878.5000) Nonabsorbable poly(ethylene terephthalate) surgical suture is a multifilament, nonabsorbable, sterile, flexible thread prepared from fibers of high molecular weight, long-chain, linear polyesters having recurrent aromatic rings as an integral component and is indicated for use in soft tissue approximation. The poly(ethylene terephthalate) surgical suture meets U.S.P. requirements as described in the U.S.P. Monograph for Nonabsorbable Surgical Sutures; it may be provided uncoated or coated; and it may be undyed or dyed with an appropriate FDA listed color additive. Also, the suture may be provided with or without a standard needle attached.

• Polyglycolic Acid Synthetic Absorbable Suture (FDA Code: GAM / 878.4493) An absorbable poly(glycolide/l-lactide) surgical suture (PGL suture) is an absorbable sterile, flexible strand as prepared and synthesized from homopolymers of glycolide and copolymers made from 90 percent glycolide and 10 percentl-lactide, and is indicated for use in soft tissue approximation. A PGL suture meets United States Pharmacopeia (U.S.P.) requirements as described in the U.S.P. "Monograph for Absorbable Surgical Sutures;" it may be monofilament or multifilament (braided) in form; it may be uncoated or coated; and it may be undyed or dyed with an FDA-approved color additive. Also, the suture may be provided with or without a standard needle attached.

• Probes (FDA Code: HXB / 888.4540)

• Probes (FDA Code: HXB / 888.4540)

• Reusable Suture Needle (FDA Code: GDL / 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.

• Scleral Depressors

• Scleral Shell (FDA Code: HQT / 886.3800) A scleral shell is a device made of glass or plastic that is intended to be inserted for short time periods over the cornea and proximal-cornea sclera for cosmetic or reconstructive purposes. An artificial eye is usually painted on the device. The device is not intended to be implanted.

• Serrated Jaws Carbide Jaw Needle Holder

• Silk Non-Absorbable Suture (FDA Code: GAP / 878.5030) Natural nonabsorbable silk surgical suture is a nonabsorbable, sterile, flexible multifilament thread composed of an organic protein called fibroin. This protein is derived from the domesticated speciesBombyx mori (B. mori ) of the familyBombycidae. Natural nonabsorbable silk surgical suture is indicated for use in soft tissue approximation. Natural nonabsorbable silk surgical suture meets the United States Pharmacopeia (U.S.P.) monograph requirements for Nonabsorbable Surgical Suture (class I). Natural nonabsorbable silk surgical suture may be braided or twisted; it may be provided uncoated or coated; and it may be undyed or dyed with an FDA listed color additive.