Device Recall OtherSonic Generic Ultrasound Transmission Gel

  • 모델명 / 제조번호(시리얼번호)
    060111 080111 090111 100811
  • 의료기기 분류등급
  • 의료기기 등급
    2
  • 이식된 장치?
    No
  • 유통
    Worldwide Distribution - United States (nationwide) including the states of: FL, MA, MS, NJ, OH, TN and VA, and the countries of: Canada and Australia.
  • 제품 설명
    Other-Sonic Generic Ultrasound Transmission Gel 5 Liters Hypoallergenic || Product Usage is a non-sterile gel used in ultrasound procedures to improve the transmission of the ultrasound signal from the transducer to the body.
  • Manufacturer
  • 1 Event

제조사

  • 제조사 주소
    Pharmaceutical Innovations, Inc., 897 Frelinghuysen Ave, Newark NJ 07114-2122
  • 제조사 모회사 (2017)
  • Source
    USFDA