Device Recall Radiesse

  • 모델명 / 제조번호(시리얼번호)
    Model number: 8063M0K1, Lot #100088744.
  • 의료기기 분류등급
  • 의료기기 등급
    3
  • 이식된 장치?
    Yes
  • 유통
    US Nationwide Distribution in the states of AR, CA, CO, CT, DC, FL, GA, IL, IN, LA, MA, MD, MI, MN, MO, NC, ND, NJ, NV, NY, OH, OK, OR, PA, PR, RI, SC, TN, TX, UT, VA, VT and WA.
  • 제품 설명
    Radiesse (+) Lidocaine, Injectable Implant 1.5cc, Rx only, P/N: 8063M0K1, Merz Aesthetics. || Product Usage: || RADIESSE is indicated for sub-dermal implantation for the correction of moderate to severe facial wrinkles and folds.
  • Manufacturer
  • 1 Event

제조사

  • 제조사 주소
    Merz North America, Inc., 6501 Six Forks Rd, Raleigh NC 27615-6515
  • 제조사 모회사 (2017)
  • Source
    USFDA