Devices

Device Recall Cholangioscopy Access Balloon

  • 모델명 / 제조번호(시리얼번호)
    DPOC-20, Lot number: W2834631
  • 의료기기 분류등급
    Gastroenterology-Urology Devices
  • 의료기기 등급
    2
  • 이식된 장치?
    Yes
  • 유통
    Worldwide distribution: USA including states of: AL, CA, FL, IL, IN, LA, MA, NC, NY, OH, PA, SC, TN, TX, WA, and WI; and countries of: Belgium, Canada, Germany, Hong Kong, and the Netherlands..
  • 제품 설명
    DPOC-20, Direct Peroral Cholangioscopy Balloon, G54951, 20 mm/17 mL, Rx Only, Cook Medical, Winston-Salem, NC 27105 || This device is intended to guide both optical and accessory devices for diagnostic and therapeutic applications during endoscopic procedures in the pancreaticobiliary system including the hepatic ducts. Also, used for endoscopic removal of biliary stones.
  • Manufacturer
    Cook Endoscopy
  • 1 Event

제조사

Cook Endoscopy
  • 제조사 주소
    Cook Endoscopy, 5951 Grassy Creek Blvd, Winston Salem NC 27105-1206
  • Source
    USFDA

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Device Recall Cholangioscopy Access Balloon
  • 모델명 / 제조번호(시리얼번호)
    Reorder number: DPOC-15, Lot numbers: W2834630, W2835211, W2871208, W2871209, W2889215, W2889216, W2889217, W2889218, W2899398, W2899399, W2902200, W2902201, W2907649, W2907650, W2910395, W2910396, W2914136, W2914137, W2916501, W2916502, W2918945, W2918946, W2920993, W2920994, W2926799, W2926800, W2928562, W2928563, W2930338, W2930882, W2932781, W2932858, W2935202, W2935243 and WR2926438.
  • 의료기기 분류등급
    Gastroenterology-Urology Devices
  • 의료기기 등급
    2
  • 이식된 장치?
    Yes
  • 유통
    Worldwide distribution: USA including states of: AL, CA, FL, IL, IN, LA, MA, NC, NY, OH, PA, SC, TN, TX, WA, and WI; and countries of: Belgium, Canada, Germany, Hong Kong, and the Netherlands..
  • 제품 설명
    DPOC-15, Cholangioscopy Access Balloon, G54951, 15 mm, Rx only, Cook Medical, Winston-Salem, NC 27105 || This device is intended to guide both optical and accessory devices for diagnostic and therapeutic applications during endoscopic procedures in the pancreaticobiliary system including the hepatic ducts. Also, used for endoscopic removal of biliary stones.
  • Manufacturer
    Cook Endoscopy