Device Recall PreludeEASE

  • 모델명 / 제조번호(시리얼번호)
    Lots: H1014678, H1039272, H1029150, H1039269, H1029151
  • 의료기기 분류등급
  • 의료기기 등급
    2
  • 이식된 장치?
    No
  • 유통
    Nationwide Distribution
  • 제품 설명
    PreludeEASE Hydrophilic Sheath Introducer Dilator || The Merit PreludeEASE Hydrophilic Sheath Introducer is intended to provide access and facilitate the percutaneous introduction of various devices into veins and/or arteries, including but not limited to the radial artery, while maintaining hemostasis for a variety of diagnostic and therapeutic procedures. The access needle with inner metal needle and outer plastic cannula is used to gain access to the vein or artery for placement of guide wires
  • Manufacturer
  • 1 Event

제조사

  • 제조사 주소
    Merit Medical Systems, Inc., 1600 W Merit Pkwy, South Jordan UT 84095-2416
  • 제조사 모회사 (2017)
  • Source
    USFDA