PROLARYN Injectable Implant 1.0 cc Gel

  • Model / Serial
    Lot Number 100079214, 100077099, 100077251, 100077252, 100077253, 100078692, 100079598, 100080204, 100081409, 100081577, 100082304, 100082438, 100083371, 100083875, 100083932
  • Product Classification
  • Device Class
    2
  • Implanted device?
    Yes
  • Distribution
    Distributed US (nationwide) including the Virgin Islands and South Africa.
  • Product Description
    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

Manufacturer

  • Manufacturer Address
    Merz North America, Inc., 6501 Six Forks Rd, Raleigh NC 27615-6515
  • Manufacturer Parent Company (2017)
  • Source
    USFDA