Device Recall Therakos CellEx Photopheresis System

  • 모델명 / 제조번호(시리얼번호)
    CLXUSA (US): Lot X120, Exp 12/10; X123, Exp 1/2011; Lot Y106, Exp 2/1/11. CLSECP (For European Union), Lot X119, Exp 12/2014; Lot X123; Exp 1/2015
  • 의료기기 분류등급
  • 의료기기 등급
    3
  • 이식된 장치?
    No
  • 유통
    Nationwide Distribution, and Canada and Germany
  • 제품 설명
    Therakos CellEx Photopheresis System; || Photopheresis Procedural Kits, for use with the THERAKOS CellEx Instrument;
  • Manufacturer
  • 1 Event

제조사

  • 제조사 주소
    Therakos Inc, 1001 Us Highway 202, Raritan NJ 08869
  • 제조사 모회사 (2017)
  • Source
    USFDA