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:
• Sinus Irrigator (FDA Code: KAR / 874.4420) |
• Smooth Fixation Pin (FDA Code: HTY / 888.3040) A smooth or threaded metallic bone fixation fastener is a device intended to be implanted that consists of a stiff wire segment or rod made of alloys, such as cobalt-chromium-molybdenum and stainless steel, and that may be smooth on the outside, fully or partially threaded, straight or U-shaped; and may be either blunt pointed, sharp pointed, or have a formed, slotted head on the end. It may be used for fixation of bone fractures, for bone reconstructions, as a guide pin for insertion of other implants, or it may be implanted through the skin so that a pulling force (traction) may be applied to the skeletal system. |
• 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) |
• Stomach and Intestinal Suture Apparatus (FDA Code: FHM / 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. |
• 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 Contractor (FDA Code: FZR / 878.4800) |
• 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) 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. |
• Surgical Punch (FDA Code: LRY / 878.4800) |
• Surgical Razor (FDA Code: LWK / 878.4800) |
• Surgical Retractor (FDA Code: GAD / 878.4800) |
• Surgical Retractor Systems (FDA Code: GAD / 878.4800) |
• Threaded Fixation Pin (FDA Code: JDW / 888.3040) |
• Tonsil Dissector (FDA Code: KBM / 874.4420) |
• Tonsil Snares (FDA Code: KBZ / 874.4420) |
• Tonsillectome (FDA Code: KCA / 874.4420) |
• Tracheal Dilators (FDA Code: KCG / 874.4420) |
• Tuning Forks (FDA Code: GWX / 882.1525) A tuning fork is a mechanical device which resonates at a given frequency and is used to diagnose hearing disorders and to test for vibratory sense. |
• Umbilical Scissors (FDA Code: HDJ / 884.4520) An obstetric-gynecologic general manual instrument is one of a group of devices used to perform simple obstetric and gynecologic manipulative functions. This generic type of device consists of the following: |
• Urological Bougie (FDA Code: FAX / 876.5520) A urethral dilator is a device that consists of a slender hollow or solid instrument made of metal, plastic, or other suitable material in a cylindrical form and in a range of sizes and flexibilities. The device may include a mechanism to expand the portion of the device in the urethra and indicate the degree of expansion on a dial. It is used to dilate the urethra. This generic type of device includes the mechanical urethral dilator, urological bougies, metal or plastic urethral sound, urethrometer, filiform, and filiform follower. |
• Uterine Curettes (FDA Code: HCY / 884.4530) An obstetric-gynecologic specialized manual instrument is one of a group of devices used during obstetric-gynecologic procedures to perform manipulative diagnostic and surgical functions (e.g., dilating, grasping, measuring, and scraping), where structural integrity is the chief criterion of device performance. This type of device consists of the following: |
• Vaginal Retractors (FDA Code: HDL / 884.4520) |
• Vascular Clamps (FDA Code: DXC / 870.4450) A vascular clamp is a surgical instrument used to occlude a blood vessel temporarily. |
• Wire Cutters (FDA Code: HXZ / 888.4540) |
• Wire Loop (FDA Code: JYQ / 874.4420) |
• Xenon Arc Endoscope Light Source (FDA Code: GCT / 876.1500) An endoscope and accessories is a device used to provide access, illumination, and allow observation or manipulation of body cavities, hollow organs, and canals. The device consists of various rigid or flexible instruments that are inserted into body spaces and may include an optical system for conveying an image to the user's eye and their accessories may assist in gaining access or increase the versatility and augment the capabilities of the devices. Examples of devices that are within this generic type of device include cleaning accessories for endoscopes, photographic accessories for endoscopes, nonpowered anoscopes, binolcular attachments for endoscopes, pocket battery boxes, flexible or rigid choledochoscopes, colonoscopes, diagnostic cystoscopes, cystourethroscopes, enteroscopes, esophagogastroduodenoscopes, rigid esophagoscopes, fiberoptic illuminators for endoscopes, incandescent endoscope lamps, biliary pancreatoscopes, proctoscopes, resectoscopes, nephroscopes, sigmoidoscopes, ureteroscopes, urethroscopes, endomagnetic retrievers, cytology brushes for endoscopes, and lubricating jelly for transurethral surgical instruments. This section does not apply to endoscopes that have specialized uses in other medical specialty areas and that are covered by classification regulations in other parts of the device classification regulations. |