Devices

Device Recall Edwards LifeStent FlexStar Biliary Stent System

제조사

Edwards Lifesciences, Llc
  • 제조사 주소
    Edwards Lifesciences, Llc, 1 Edwards Way, Irvine CA 92614-5688
  • Source
    USFDA

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Device Recall Edwards LifeStent FlexStar Biliary Stent System
  • 모델명 / 제조번호(시리얼번호)
    Lot Numbers: FR6F0111 (Exp 2008/06), FR6G0120 (Exp 2008/08), FR6G0121 (Exp 2008/08), FR6H0135 (Exp 2008/08), FR6H0182 (Exp 2008/08) and FR6H0192 (Exp 2008/08)
  • 의료기기 분류등급
    Gastroenterology-Urology Devices
  • 의료기기 등급
    2
  • 이식된 장치?
    Yes
  • 유통
    Nationwide Distribution
  • 제품 설명
    Edwards LifeStent FlexStar Biliary Stent System; Biliary catheter and accessories; Model Number: EX060603CD; Edwards Lifesciences LLC, Irvine, CA 92614.
  • Manufacturer
    Edwards Lifesciences, Llc
Device Recall Edwards LifeStent FlexStar Biliary Stent System
  • 모델명 / 제조번호(시리얼번호)
    Lot Numbers: FR6G0118 (2008/07), FR6G0119 (2008/08), FR6H0137 (Exp 2008/08), FR6H0194 (Exp 2008/08) and FR6H0203 (Exp 2008/08)
  • 의료기기 분류등급
    Gastroenterology-Urology Devices
  • 의료기기 등급
    2
  • 이식된 장치?
    Yes
  • 유통
    Nationwide Distribution
  • 제품 설명
    Edwards LifeStent FlexStar Biliary Stent System; Biliary catheter and accessories; Model Number: EX060403CD; Edwards Lifesciences LLC, Irvine, CA 92614.
  • Manufacturer
    Edwards Lifesciences, Llc
Device Recall Edwards LifeStent FlexStar Biliary Stent System
  • 모델명 / 제조번호(시리얼번호)
    Lot Numbers: FR6G0122, (Exp 2008/07), FR6G0123 (Exp 2008/08), FR6H0193 (Exp 2008/08) and FR6H0201 (Exp 2008/08).
  • 의료기기 분류등급
    Gastroenterology-Urology Devices
  • 의료기기 등급
    2
  • 이식된 장치?
    Yes
  • 유통
    Nationwide Distribution
  • 제품 설명
    Edwards LifeStent FlexStar Biliary Stent System; Biliary catheter and accessories; Model Number: EX060803CD; Edwards Lifesciences LLC, Irvine, CA 92614.
  • Manufacturer
    Edwards Lifesciences, Llc
Device Recall Edwards LifeStent FlexStar Biliary Stent System
  • 모델명 / 제조번호(시리얼번호)
    Lot Numbers: FR6G0124 (Exp 2008/08), FR6G0125 (Exp 2008/07) and FR6H0181 (Exp 2008/08).
  • 의료기기 분류등급
    Gastroenterology-Urology Devices
  • 의료기기 등급
    2
  • 이식된 장치?
    Yes
  • 유통
    Nationwide Distribution
  • 제품 설명
    Edwards LifeStent FlexStar Biliary Stent System; Biliary catheter and accessories; Model Number: EX070403CD; Edwards Lifesciences LLC, Irvine, CA 92614.
  • Manufacturer
    Edwards Lifesciences, Llc
Device Recall Edwards LifeStent FlexStar Biliary Stent System
  • 모델명 / 제조번호(시리얼번호)
    Lot Number: FR6G0129.
  • 의료기기 분류등급
    Gastroenterology-Urology Devices
  • 의료기기 등급
    2
  • 이식된 장치?
    Yes
  • 유통
    Nationwide Distribution
  • 제품 설명
    Edwards LifeStent FlexStar Biliary Stent System; Biliary catheter and accessories; Model Number: EX080403CD; Edwards Lifesciences LLC, Irvine, CA 92614.
  • Manufacturer
    Edwards Lifesciences, Llc
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