Profile: R Medical Inc. provides instruments & equipment for both open surgery & for endoscopy. We specialize in Easy-port® trocars, the Rudolf laparoscopy system instruments with cameras and light sources. We offer products for both minimally invasive surgery & open surgery.
• Microsurgical Instruments (FDA Code: GZX / 882.4525) A microsurgical instrument is a nonpowered surgical instrument used in neurological microsurgery procedures. |
• Mouth Gags (FDA Code: KBN / 874.4420) |
• Nasal Curette (FDA Code: KAP / 874.4420) |
• Nasal Punch (FDA Code: KAY / 874.4420) |
• Nasal Rasps (FDA Code: KBA / 874.4420) |
• Nasal Rongeur (FDA Code: KBB / 874.4420) |
• Nasal Scissors (FDA Code: KBD / 874.4420) |
• Nasal Scissors Straight (FDA Code: KBD / 874.4420) |
• Non Dental Irrigating Syringe (FDA Code: KYZ / 880.6960) An irrigating syringe is a device intended for medical purposes that consists of a bulb or a piston syringe with an integral or a detachable tube. The device is used to irrigate, withdraw fluid from, or instill fluid into, a body cavity or wound. |
• Non Rigid Laryngoscope (FDA Code: CAL / 868.5530) A flexible laryngoscope is a fiberoptic device used to examine and visualize a patient's upper airway and aid placement of a tracheal tube. |
• Non-Electric Biopsy Forceps (FDA Code: FCL / 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. |
• Non-Sterile Specimen Container (FDA Code: NNI / 864.3250) A specimen transport and storage container, which may be empty or prefilled, is a device intended to contain biological specimens, body waste, or body exudate during storage and transport in order that the matter contained therein can be destroyed or used effectively for diagnostic examination. If prefilled, the device contains a fixative solution or other general purpose reagent to preserve the condition of a biological specimen added to the container. This section does not apply to specimen transport and storage containers that are intended for use as part of an over-the-counter test sample collection system for drugs of abuse testing. |
• Operating Room Scrub Brush (FDA Code: GEC / 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. |
• Ophthalmic Curette (FDA Code: HNZ / 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 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 Operating Spectacle (FDA Code: HOH / 886.4770) Ophthalmic operating spectacles (loupes) are devices that consist of convex lenses or lens systems intended to be worn by a surgeon to magnify the surgical site during ophthalmic surgery. |
• Ophthalmic Retractor (FDA Code: HNI / 886.4350) |
• Ophthalmic Spatula (FDA Code: HND / 886.4350) |
• Ophthalmic Speculum (FDA Code: HNC / 886.4350) |
• Ophthalmic Suture Scissors (FDA Code: HNF / 886.4350) |
• Orthopedic Cutting Instrument (FDA Code: HTZ / 878.4800) |
• Orthopedic Knife (FDA Code: HTS / 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. |
• Orthopedic Manual Surgical Instrument (FDA Code: LXH / 888.4540) |
• Orthopedic Needle Holder (FDA Code: HXK / 888.4540) |
• Orthopedic Osteotome (FDA Code: HWM / 878.4800) |
• Otoscopes (FDA Code: ERA / 874.4770) An otoscope is a device intended to allow inspection of the external ear canal and tympanic membrane under magnification. The device provides illumination of the ear canal for observation by using an AC- or battery-powered light source and an optical magnifying system. |
• Periodontal Probes |
• Probes (FDA Code: HXB / 888.4540) |
• Probes (FDA Code: HXB / 888.4540) |
• Reusable Suture Needle (FDA Code: GDL / 878.4800) |
• Rib Rongeurs (FDA Code: HTX / 888.4540) |
• Rigid Laryngoscope (FDA Code: CCW / 868.5540) A rigid laryngoscope is a device used to examine and visualize a patient's upper airway and aid placement of a tracheal tube. |
• Ruler and Caliper (FDA Code: FTY / 878.4800) |
• Saws (FDA Code: HSO / 878.4800) |
• Scalpel Blade (FDA Code: GES / 878.4800) |
• Scalpel Handle (FDA Code: GDZ / 878.4800) |
• Self-Retaining Retractors (FDA Code: FFO / 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. |
• Sinus Cannula (FDA Code: KAM / 878.4800) |
• 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. |
• Speculum Accessories (FDA Code: FXG / 878.1800) |
• Surgical Camera and Accessories (FDA Code: KQM / 878.4160) A surgical camera and accessories is a device intended to be used to record operative procedures. |
• Surgical Curette (FDA Code: FZS / 878.4800) |
• Surgical Cutter (FDA Code: FZT / 878.4800) |
• Surgical Knife (FDA Code: EMF / 878.4800) |
• Surgical Needle Guide (FDA Code: GDF / 878.4800) |
• Surgical Orthopedic Scissors (FDA Code: HRR / 888.4540) |
• Surgical Punch (FDA Code: LRY / 878.4800) |