PENTAX Video Duodenoscope

제조사

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  • 모델명 / 제조번호(시리얼번호)
  • 제품 설명
    Video flexible duodenoscope
  • Manufacturer
  • 모델명 / 제조번호(시리얼번호)
    Model Numbers: Ed-3490TK and ED-3270K
  • 의료기기 분류등급
  • 의료기기 등급
    2
  • 이식된 장치?
    No
  • 유통
    Worldwide Distribution-US (Nationwide) including states of: AL, AZ, CA, CO, CT, DC, DE, FL, GA, ID, IL, IN, KS, KY, LA, MA, MD, MI, MO, MS, MT, NC, NH, NJ, NV, NY, OH, OK, PA, PR, TN, TX, UT, VA, WA, WI, WV, WY;. and country of: CANADA.
  • 제품 설명
    Video Duodenoscope || 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)
    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)
    FD-34V2, ED-3490TK, ED-3470TK, ED-3270K, ED-3230K, ED-3230, ED-3430T, ED-3430K, ED-3430TK, ED-3430, ED-3630T, ED-3670TK
  • 제품 설명
    MD: Flexible video duodenoscope
  • Manufacturer
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