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Diwymed Production Gmbh

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E-Mail:
Address: By Hassler 5, Tuttlingen 78532, Germany
Phone: +49-(7462)-200116 | Map/Directions >>
 
 

Profile: Diwymed Production Gmbh offers surgical retractors, probes, pliers, surgical hammers, retainers, medical rasps and bone hooks.

FDA Registration Number: 9680938
US Agent: Karen Parker / Synthes (usa) Products Llc
Phone: +1-(610)-719-6567  E-Mail:

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• Awl (FDA Code: HWJ / 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.
• Bender (FDA Code: HXW / 888.4540)
• Bending/Contouring Instrument (FDA Code: HXP / 888.4540)
• Bone Hooks (FDA Code: KIK / 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.
• Bone Mallets (FDA Code: HXL / 878.4800)
• Bone Rasps (FDA Code: HTR / 878.4800)
• Bone Taps (FDA Code: HWX / 888.4540)
• Broach (FDA Code: HTQ / 888.4540)
• Calipers (FDA Code: KTZ / 888.4150)
A caliper for clinical use is a compass-like device intended for use in measuring the thickness or diameter of a part of the body or the distance between two body surfaces, such as for measuring an excised skeletal specimen to determine the proper replacement size of a prosthesis.
• Cervical Intervertebral Fusion Device With Bone Graft (FDA Code: ODP / 888.3080)
• Compression Instrument (FDA Code: HWN / 888.4540)
• Curettes (FDA Code: HTF / 878.4800)
• 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.
• Flexible Depth Gauge (FDA Code: HTJ / 888.4300)
• Forceps (FDA Code: HTD / 878.4800)
• General & Plastic Surgery Forceps (FDA Code: GEN / 878.4800)
• General & Plastic Surgery Surgical Dissector (FDA Code: GDI / 878.4800)
• General & Plastic Surgery Surgical Hook (FDA Code: GDG / 878.4800)
• Guiding Probes
• Human Bone Rasps (FDA Code: HTR / 878.4800)
• Impactor (FDA Code: HWA / 888.4540)
• Instrument Surgical Guide (FDA Code: FZX / 878.4800)
• Laparoscopic Probes
• Laser Power Probe
• Manual Surgical Chisel (FDA Code: FZO / 878.4800)
• Medical Probes (FDA Code: HXB / 888.4540)
• Medical Rasps (FDA Code: HTR / 878.4800)
• Multiple Component Fixation Appliance (FDA Code: KTT / 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.
• Orthopedic Cutting Instrument (FDA Code: HTZ / 878.4800)
• Orthopedic Elevator (FDA Code: HTE / 878.4800)
• Orthopedic Manual Surgical Instrument (FDA Code: LXH / 888.4540)
• Orthopedic Osteotome (FDA Code: HWM / 878.4800)
• Periodontal Probes
• Pin Crimper (FDA Code: HXQ / 888.4540)
• Probes (FDA Code: HXB / 888.4540)
• Probes (FDA Code: HXB / 888.4540)
• Prosthesis Driver (FDA Code: HWR / 888.4540)
• Reamer (FDA Code: HTO / 888.4540)
• Rib Rongeurs (FDA Code: HTX / 888.4540)
• Scalpel Handle (FDA Code: GDZ / 878.4800)
• Screwdriver (FDA Code: HXX / 888.4540)
• Small Depth Gauge (FDA Code: HTJ / 888.4300)
• Spondylolisthesis Spinal Fixation Orthosis (FDA Code: MNH / 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 Hammer (FDA Code: FZY / 878.4800)
• Surgical Pliers (FDA Code: HTC / 878.4800)
• Surgical Punch (FDA Code: LRY / 878.4800)
• Surgical Retainer (FDA Code: GCZ / 878.4800)
• Surgical Retractor (FDA Code: GAD / 878.4800)
• Surgical Retractor Systems (FDA Code: GAD / 878.4800)
• Surgical Stylet (FDA Code: GAH / 878.4800)

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