Device Recall GYRUS ACMI, Sterile EO

  • 모델명 / 제조번호(시리얼번호)
    All product manufactured before July 28, 2014.
  • 의료기기 분류등급
  • 의료기기 등급
    2
  • 이식된 장치?
    No
  • 유통
    Worldwide Distribution - USA including US: AL, AZ, CA, FL, GA, HI, IL, IN, IA, KY, MA,MI,MS, NJ, NY, NC, OH, PA, SC, TN, UT, and WA. Internationally to ITALY, SPAIN, UNITED KINGDOM, and CHINA.
  • 제품 설명
    GYRUS ACMI, REF 3345 -Everest BiCOAG MOLly Forceps 5mm/45cm || REF 3345PK - PKS MOLly Forceps 5mm/45cm || REF 3640 -Everest BiCOAG Macro Jaw Forceps 5mm/45cm || REF 3640PK- PKS Macro Jaw Forceps 5mm/45cm || REF 3844- Everest BiCOAG LP Scissors 5mm/45cm || REF 910010PK- PKS MOLly Forceps 5mm/45cm || Single-use, sterile devices intended for the electrosurgical coagulation, mechanical grasping, and dissection of tissue during the performance of laparoscopic and general surgical procedures.
  • Manufacturer
  • 1 Event

제조사

  • 제조사 주소
    Gyrus Medical, Inc, 6655 Wedgwood Rd N Ste 160, Osseo MN 55311-3613
  • 제조사 모회사 (2017)
  • Source
    USFDA