Profile: Koga Isotope Co., Ltd. specializes in the field of radiation sterilization of medical equipment.
FDA Registration Number: 3002807408
US Agent: Kristi O Smedley / Center For Regulatory Services, Inc.
Phone: +1-(703)-590-7337 Fax: +1-(703)-580-8637 E-Mail:
4 Products/Services (Click for related suppliers)
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• Blood Collection Lancet (FDA Code: FMK / 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. |
• Intravascular Radiotherapy, Beta Radiation |
• Intravascular Radiotherapy, Gamma Radiation |
• Radiation Sources |