Profile: Rudolf Medical Gmbh + Co. Kg manufactures medical devices, equipments and instruments for open & minimally invasive surgery. The product lines for minimally invasive surgery instruments, endoscopes and equipment are covers for laparoscopy, endo-neurosurgery, arthroscopy, urology and gynaecology disciplines. We offer EasyPort® trocar system, ETV, EMD, endo-urology and endo-gynecology for minimally invasive surgery. The neurosurgery catalog contains a wide variety of instruments, micro instrument sets and containers. The ENT catalog is organized by different ENT disciplines are sinuscopy, HF surgery, otology, rhinology, rhinoplasty, adenotomie, tonsillectomy, tracheotomy, laryngology, mndolaryngeal microsurgery and bronchoscopy.
FDA Registration Number: 8010298
US Agent: Franz Menean / Medagent Inc.
Phone: +1-(603)-570-2039 Fax: +1-(603)-570-2055 E-Mail:
• Nasal Scissors Straight (FDA Code: KBD / 874.4420) |
• Nasal Snare (FDA Code: KBE / 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-Disposable Suprapubic Trocar and Cannula (FDA Code: FBM / 876.5090) A suprapubic urological catheter and accessories is a flexible tubular device that is inserted through the abdominal wall into the urinary bladder with the aid of a trocar and cannula. The device is used to pass fluids to and from the urinary tract. This generic type of device includes the suprapubic catheter and tube, Malecot catheter, catheter punch instrument, suprapubic drainage tube, and the suprapubic cannula and trocar. |
• 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-Powered Goniometer (FDA Code: KQW / 888.1520) A nonpowered goniometer is a mechanical device intended for medical purposes to measure the range of motion of joints. |
• Non-Powered Surgical Instrument (FDA Code: HAO / 882.4535) A nonpowered neurosurgical instrument is a hand instrument or an accessory to a hand instrument used during neurosurgical procedures to cut, hold, or manipulate tissue. It includes specialized chisels, osteotomes, curettes, dissectors, elevators, forceps, gouges, hooks, surgical knives, rasps, scissors, separators, spatulas, spoons, blades, blade holders, blade breakers, probes, etc. |
• Non-Sterile Absorbent Tipped Applicator (FDA Code: KXF / 880.6025) An absorbent tipped applicator is a device intended for medical purposes that consists of an absorbent swab on a wooden, paper, or plastic stick. The device is used to apply medications to, or to take specimens from, a patient. |
• 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. |
• Nose And Throat Ear Bur (FDA Code: EQJ / 874.4140) An ear, nose, and throat bur is a device consisting of an interchangeable drill bit that is intended for use in an ear, nose, and throat electric or pneumatic surgical drill (874.4250) for incising or removing bone in the ear, nose, or throat area. The bur consists of a carbide cutting tip on a metal shank or a coating of diamond on a metal shank. The device is used in mastoid surgery, frontal sinus surgery, and surgery of the facial nerves. |
• One-Piece Scalpel (FDA Code: GDX / 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 Caliper (FDA Code: HOE / 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 Curette (FDA Code: HNZ / 886.4350) |
• Ophthalmic Forceps (FDA Code: HNR / 886.4350) |
• Ophthalmic Headband Mirror (FDA Code: HKF / 886.1500) A headband mirror is a device intended to be strapped to the head of the user to reflect light for use in examination of the eye. |
• 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 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 Burr (FDA Code: HTT / 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 Cutting Instrument (FDA Code: HTZ / 878.4800) |
• Orthopedic Elevator (FDA Code: HTE / 878.4800) |
• Orthopedic Knife (FDA Code: HTS / 888.4540) |
• 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) |
• Rectal Speculums (FDA Code: FFQ / 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. |
• Removable Skin Clip (FDA Code: FZQ / 878.4320) A removable skin clip is a clip-like device intended to connect skin tissues temporarily to aid healing. It is not absorbable. |
• Reusable Suture Needle (FDA Code: GDL / 878.4800) |
• Reusable Vein Stripper (FDA Code: GAI / 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) |
• 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. |
• Screwdriver (FDA Code: HXX / 888.4540) |
• Self-Retaining Retractors (FDA Code: FFO / 876.4730) |
• Sinus Cannula (FDA Code: KAM / 878.4800) |