Device Recall Instructions for Use (IFU) and Manual NobPrl CC Guided Surgery Kit

  • Modèle / numéro de série
    Article 38072-all lots
  • Classification du dispositif
  • Classe de dispositif
    2
  • Dispositif implanté ?
    No
  • Distribution
    Worldwide Distribution: US (nationwide) and Countries of: Austria, Belgium, Canada, Germany, Denmark, Spain, France, Great Britain, Italy, Netherlands, Norway, Poland, Portugal, Russia, and Turkey.
  • Description du dispositif
    Instructions for Use (IFU) and Manual NobPrl CC Guided Surgery Kit || Instructions for Use (IFU): "NobelGuide for NobelParallel Conical Connection", id # 2002 and Manual: Guided Surgery with NobelParallel Conical Connection", id # 79423. Article # 38072, Nobel Parallel CC Guided Surgery Kit. || The Guided Surgery Kit is used as part of the installation process of NobelParallel CC Implants. The purpose of the IFU is to instruct the user how to use the products safely. The purpose of the manual is to guide the user through the usage of NobelGuide for NobelParallel CC.
  • Manufacturer
  • 1 Event

Fabricant

  • Adresse du fabricant
    Nobel Biocare Usa Llc, 22715/22725 Savi Ranch Pkwy, Yorba Linda CA 92887
  • Société-mère du fabricant (2017)
  • Source
    USFDA