PROLARYN Injectable Implant 1.0 cc Gel

  • 모델명 / 제조번호(시리얼번호)
    Lot Number 100079214, 100077099, 100077251, 100077252, 100077253, 100078692, 100079598, 100080204, 100081409, 100081577, 100082304, 100082438, 100083371, 100083875, 100083932
  • 의료기기 분류등급
  • 의료기기 등급
    2
  • 이식된 장치?
    Yes
  • 유통
    Distributed US (nationwide) including the Virgin Islands and South Africa.
  • 제품 설명
    PROLARYN Injectable Implant 1.0 cc Gel, Model No. 8602M0K5. A restorable implant material to aid in surgical reconstructions as a space occupying material in laryngeal surgical procedures for vocal fold medialization and augmentation.
  • Manufacturer
  • 1 Event

제조사

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