Profile: Scandmed Ab specializes in surgical instruments for orthopedic and neurosurgical products. Our products include bone osteotomes, scandmed electronic pressure meter for checking air and gas pressure and scandmed cuffs for orthopedic and plastic surgery. This bone osteotomes used for bone surgery, bone cement removal osteotomes, chisels are designed by surgeons. Our pressure sensor is a silicon chip piezoresistive with temperature compensation and trimming elements integrated on the chip. This scandmed cuffs for orthopedic and plastic surgery used as single and double cuffs for orthopedic and plastic surgery with silicone bladder and an outer textile part with velcro. it is used as Velcro® tape and strap with plastic clamp for increased safety and long silicon bladder to facilitate correct choice of cuffs, different sizes of both single and double cuffs, both machine washable and autoclavable cuffs, custom made cuffs on demand, color coded cuffs and hoses and disposable cuffs and no latex.
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• General Surgical Manual Instrument (FDA Code: MDM / 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. |
• Orthopedic Manual Surgical Instrument (FDA Code: LXH / 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. |
• Pneumatic Tourniquet (FDA Code: KCY / 878.5910) A pneumatic tourniquet is an air-powered device consisting of a pressure-regulating unit, connecting tubing, and an inflatable cuff. The cuff is intended to be wrapped around a patient's limb and inflated to reduce or totally occlude circulation during surgery. |