Device Recall Sydney IVF Culture Oil

  • 모델명 / 제조번호(시리얼번호)
    Lot A895473 (K-SICO-50) and Lot A895499 (K-SICO-200).
  • 의료기기 분류등급
  • 의료기기 등급
    2
  • 이식된 장치?
    No
  • 유통
    Worldwide Distribution - USA (nationwide) including the states of IL, KS, KY, MA, NJ. TN, TX, UT, VA, WI, WV, and the country of Barbados.
  • 제품 설명
    Sydney IVF Culture Oil, REF, K- SICO- 50, 50 mL. and K-SICO-200, 200 mL,Store at 2-8 C, Sterile, Cook Medical, William A Cook Australia LTD, || Product Usage: || Culture oil is intended to be used as an oil overlay for cultures of gametes, zygotes, or embryos in assisted reproductive technology (ART) and micro manipulation procedures. It is used to reduce the osmotic stress due to evaporation and to reduce pH fluctuations.
  • Manufacturer
  • 1 Event

제조사

  • 제조사 주소
    Cook, Inc., 750 Daniels Way, Bloomington IN 47404-9120
  • Source
    USFDA