Profile: Mahe-Barthelmes Medizintechnik Gmbh provides medical equipment. We offer products for endoscopy, arthroscopy, ENT, laparoscopy and urology. The endoscopy products are insufflator 1400, purgorator 5100, CCD 2200 camera adaptor, 3180 X and HL 2500 light source. Our arthroscopy product lines are accessories, forceps, handles, hook punches, hook scissors, resectors, trocar sheath, wide jaw punches, power cutters and punch retrogrades. The accessories are arthro-shaver control unit, bayonet-knife tip, banana knife tooth-edged knurled handle, cartilage files, cold light source, curette tip, and drainage cannula.

The company is ISO 9001 certified.

FDA Registration Number: 8010447
US Agent: Dagmar Maeser / Business Support International
Phone: +1-(212)-331-8358  Fax: +1-(212)-257-6441  E-Mail:

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• Orthopedic Wire Passer (FDA Code: HXI / 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.

• Pin Surgical Driver (FDA Code: GFC / 878.4820) Surgical instrument motors and accessories are AC-powered, battery-powered, or air-powered devices intended for use during surgical procedures to provide power to operate various accessories or attachments to cut hard tissue or bone and soft tissue. Accessories or attachments may include a bur, chisel (osteotome), dermabrasion brush, dermatome, drill bit, hammerhead, pin driver, and saw blade.

• Powered Saw and Accessories (FDA Code: HAB / 878.4820)

• Prosthesis Driver (FDA Code: HWR / 888.4540)

• Reamer (FDA Code: HTO / 888.4540)

• Resectoscope Working Element (FDA Code: FDC / 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.

• Resectoscopes (FDA Code: FJL / 876.1500)

• Saws (FDA Code: HSO / 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.

• Screwdriver (FDA Code: HXX / 888.4540)

• Small Depth Gauge (FDA Code: HTJ / 888.4300) A depth gauge for clinical use is a measuring device intended for various medical purposes, such as to determine the proper length of screws for fastening the ends of a fractured bone.

• 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.

• Spinal Pedicle Fixation Orthosis (FDA Code: MNI / 888.3070) Pedicle screw spinal systems are multiple component devices, made from a variety of materials, including alloys such as 316L stainless steel, 316LVM stainless steel, 22Cr-13Ni-5Mn stainless steel, Ti-6Al-4V, and unalloyed titanium, that allow the surgeon to build an implant system to fit the patient's anatomical and physiological requirements. Such a spinal implant assembly consists of a combination of anchors (e.g., bolts, hooks, and/or screws); interconnection mechanisms incorporating nuts, screws, sleeves, or bolts; longitudinal members (e.g., plates, rods, and/or plate/rod combinations); and/or transverse connectors.

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

• Surgical Pliers (FDA Code: HTC / 878.4800)

• Surgical Retractor (FDA Code: GAD / 878.4800)

• Surgical Retractor Systems (FDA Code: GAD / 878.4800)

• Surgical Trays (FDA Code: LRP / 878.4800)

• Surgical Trays (FDA Code: LRP / 878.4800)

• Templates (FDA Code: HWT / 888.4800) A template for clinical use is a device that consists of a pattern or guide intended for medical purposes, such as selecting or positioning orthopedic implants or guiding the marking of tissue before cutting.

• Threaded Fixation Pin (FDA Code: JDW / 888.3040)

• Titanium Microsurgical Instruments

• Unipolar Laparoscopic Coagulator (FDA Code: HFG / 884.4160) A unipolar endoscopic coagulator-cutter is a device designed to destroy tissue with high temperatures by directing a high frequency electrical current through the tissue between an energized probe and a grounding plate. It is used in female sterilization and in other operative procedures under endoscopic observation. This generic type of device may include the following accessories: an electrical generator, probes and electrical cables, and a patient grounding plate. This generic type of device does not include devices used to perform female sterilization under hysteroscopic observation.

• Water Jet Lavage Unit (FDA Code: FQH / 880.5475) A jet lavage is a device used to clean a wound by a pulsatile jet of sterile fluid. The device consists of the pulsing head, tubing to connect to a container of sterile fluid, and a means of propelling the fluid through the tubing, such as an electric roller pump.

• Wire Cutters (FDA Code: HXZ / 888.4540)

• Wire Holding Forceps (FDA Code: HYA / 878.4800)

• Wrench (FDA Code: HXC / 888.4540)

• Y-Stent Forceps