Profile: Hemostatix Medical Technologies, LLC offers hemostatix thermal scalpel system. Our hemostatix thermal scalpel system offers exact temperature control ranging from 70° to 300° C at the push of a button. This allows to precisely heat the razor-sharp, non-stick blade of the shaw scalpel to seal sensitive tissues with a thin collagenous layer, which aids in reducing blood loss up to 60 percent. To quickly achieve maximum hemostasis, coag bar on the handle is pressed and the unit automatically jumps to 300° C. The instrument's temperature can be adjusted by the surgeon, in increments of 10° C, based on hemostasis requirements. The system's control unit constantly monitors and adjusts the power required to maintain the blade at the set temperature. The large LED indicates the blade's current temperature, which eliminates the guesswork associated with wattage or power settings used with electrosurgical devices. Our product line includes scalpel handle for model 150 and 600D controller units, scalpel for model 600D and 2400Z controller units, scalpel for model 600D and 2400Z controller units, scalpel for model 150 and 2400Z controller units and model 2400Z controller unit.
FDA Registration Number: 3006119098
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• Electrosurgical Cutting and Coagulation Device (FDA Code: GEI / 878.4400) An electrosurgical cutting and coagulation device and accessories is a device intended to remove tissue and control bleeding by use of high-frequency electrical current. |
• Scalpel Blade (FDA Code: GES / 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. |
• Scalpel Handle (FDA Code: GDZ / 878.4800) |
• Scalpels |