Profile: Zhangjiagag Zhiyi Medical Health Products Co., Ltd provides surgical drapes, dental bibs, health care pads, raw materials and plastic composites. We offer universal drape set, side drape and angiography, spinal & surgical drape set.
FDA Registration Number: 3008192718
US Agent: David Lennarz / Registrar Corp
Phone: +1-(757)-224-0177 Fax: +1-(757)-224-0179 E-Mail:
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• Disposable Surgical Drape (FDA Code: KKX / 878.4370) A surgical drape and drape accessories is a device made of natural or synthetic materials intended to be used as a protective patient covering, such as to isolate a site of surgical incision from microbial and other contamination. The device includes a plastic wound protector that may adhere to the skin around a surgical incision or be placed in a wound to cover its exposed edges, and a latex drape with a self-retaining finger cot that is intended to allow repeated insertion of the surgeon's finger into the rectum during performance of a transurethral prostatectomy. |
• Disposable Surgical Instrument Kit (FDA Code: KDD / 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. |
• Limb Cover (FDA Code: IPM / 890.3025) A prosthetic and orthotic accessory is a device intended for medical purposes to support, protect, or aid in the use of a cast, orthosis (brace), or prosthesis. Examples of prosthetic and orthotic accessories include the following: A pelvic support band and belt, a cast shoe, a cast bandage, a limb cover, a prosthesis alignment device, a postsurgical pylon, a transverse rotator, and a temporary training splint. |
• Operating Room Shoe Cover (FDA Code: FXP / 878.4040) Surgical apparel are devices that are intended to be worn by operating room personnel during surgical procedures to protect both the surgical patient and the operating room personnel from transfer of microorganisms, body fluids, and particulate material. Examples include surgical caps, hoods, masks, gowns, operating room shoes and shoe covers, and isolation masks and gowns. Surgical suits and dresses, commonly known as scrub suits, are excluded. |
• Sterile Surgical Drapes (FDA Code: KKX / 878.4370) |
• Surgical Drapes (FDA Code: KKX / 878.4370) |
• Surgical Drapes & Packs (FDA Code: KKX / 878.4370) |
• Surgical Masks (FDA Code: FXX / 878.4040) |
• Urology Surgical Drapes (FDA Code: KKX / 878.4370) |