Mondeal Medical Systems Gmbh

Click Here To EMAIL INQUIRY
Contact: Jay Evans
Web: http://www.mondeal.de
E-Mail:
Address: Gewerbering 7, Muhlheim A.D. Donau 78750, Germany
Phone: +49-(7463)-99307-0 | Fax: +49-(7463)-99307-33 | Map/Directions >>

Profile: Mondeal Medical Systems Gmbh deals with medical systems. We offer oral & cranio-maxillofacial systems and traumas. Oral and cranial-maxillofacial system components are used for oral, maxillofacial, and cranial surgery set apart due to the large variety of screws and plates for the diversified usages. This area ranges from osteosynthesis and reconstruction to pre-implantology, distraction and orthodontic-systems. In the area of traumatology, implants and instruments serve in the surgical treatment of abnormalities, fractures and tumor diseases of the hand, foot, shoulder, pelvis and the long epiphysis bone of the arm and leg.

FDA Registration Number: 3004517085
US Agent: Franz Menean / Medagent, Inc.
Phone: +1-(603)-570-2039 Fax: +1-(603)-570-2055 E-Mail:

22 Products/Services (Click for related suppliers)

• Bender (FDA Code: HXW / 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.

• Bone Fixation Plate (FDA Code: HRS / 888.3030)

Single/multiple component metallic bone fixation appliances and accessories are devices intended to be implanted consisting of one or more metallic components and their metallic fasteners. The devices contain a plate, a nail/plate combination, or a blade/plate combination that are made of alloys, such as cobalt-chromium-molybdenum, stainless steel, and titanium, that are intended to be held in position with fasteners, such as screws and nails, or bolts, nuts, and washers. These devices are used for fixation of fractures of the proximal or distal end of long bones, such as intracapsular, intertrochanteric, intercervical, supracondylar, or condylar fractures of the femur; for fusion of a joint; or for surgical procedures that involve cutting a bone. The devices may be implanted or attached through the skin so that a pulling force (traction) may be applied to the skeletal system.

• Bone Fixation Screw (FDA Code: HWC / 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.

• Cannulated Screw Fracture Fixation System

• 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.

• Drill Bit (FDA Code: HTW / 888.4540)

• Drill Brace (FDA Code: HXY / 888.4540)

• ENT Manual Surgical Instrument (FDA Code: LRC / 874.4420)

• Flexible Depth Gauge (FDA Code: HTJ / 888.4300)

• General & Plastic Surgery Surgical Cannula (FDA Code: GEA / 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.

• General Surgical Manual Instrument (FDA Code: MDM / 878.4800)

• Maxillofacial Prosthesis

• Neuro Surgery Surgical Instrument

• Non-Powered Endoscopic Grasping/Cutting Instrument (FDA Code: OCZ / 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.

• Orthopedic Cutting Instrument (FDA Code: HTZ / 878.4800)

• Screwdriver (FDA Code: HXX / 888.4540)

• Self-Drilling Screws

• Small Depth Gauge (FDA Code: HTJ / 888.4300)

• Surgical Trays (FDA Code: LRP / 878.4800)

• Titanium Implant System

• Wrench (FDA Code: HXC / 888.4540)