Pentax

  • 모델명 / 제조번호(시리얼번호)
    Model #'s FCP-8P and FCP-9P
  • 의료기기 분류등급
  • 의료기기 등급
    2
  • 이식된 장치?
    No
  • 유통
    Worldwide Distribution - US (Nation Wide) including Puerto Rico and Internationally to Denmark, Guam
  • 제품 설명
    Choledochoscope || Intended to provide optical visualization of and therapeutic access to the Biliary Tree. This anatomy includes, but is not restricted to, the organs, tissues and subsystems: Common Bile, Hepatic, Cystic and Pancreatic Ducts. The instrument is introduced via the working channel of a Duodenoscope positioned for access to the Common bile Duct when indications consistent with the need for procedure are observed in adult and pediatric patient populations.
  • Manufacturer
  • 1 Event

제조사

  • 제조사 주소
    Pentax Medical Company, 3 Paragon Dr, Montvale NJ 07645-1782
  • 제조사 모회사 (2017)
  • Source
    USFDA

유사한 이름을 가진 의료기기 1건 유사한 이름을 가진 의료기기 143 건

데이터에 대해 더 자세히 알아보기 여기

  • 모델명 / 제조번호(시리얼번호)
    All Serial Numbers
  • 의료기기 분류등급
  • 의료기기 등급
    2
  • 이식된 장치?
    No
  • 유통
    USA (nationwide) Distribution to the states of including Puerto Rico : AL, AZ, CA, CO, CT, DE, FL, GA, ID, IL, IN, KS, KY, LA, MA, MD, MI, MN, MO, MS, MT, NC, NH, NJ, NV, NY, OH, OK, PA, TN, TX, UT, VA, WA, WI, WV and WY, and the District of Columbia.
  • 제품 설명
    Pentax Video Duodenoscope Model: ED-3490TK (UDI of design being recalled: 04961333232420) || These instruments are intended to provide optical visualization of (via a video monitor), and therapeutic access to, the biliary tract via the upper GI tract. This anatomy includes, but is not restricted to, the organs; tissues; and subsystems: esophagus, stomach, duodenum, common bile, hepatic, and cystic ducts.
  • Manufacturer
  • 모델명 / 제조번호(시리얼번호)
  • Manufacturer
    N/A
하나 더 138 건 더