Lumenis

Un dispositif médical dans la base de données

  • Modèle / numéro de série
    GA-0007500 (VersaCut + System with Inverted H/P) and GA-0007600 (VersaCut + System with Regular H/P). Only the hand pieces for the system (SA4769200 inverted HP, SA4768700 regular HP) are affected by this recall.
  • Classification du dispositif
  • Classe de dispositif
    2
  • Dispositif implanté ?
    No
  • Distribution
    Worldwide Distribution - US including CA, PA, MA, FL, and NY, and Internationally to Italy, Germany, Australia, China, Great Britian, United Kingdom, Taiwan, France, Peru, Mexico, Turkey, Spain, and Russia.
  • Description du dispositif
    Lumenis VersaCut+ Tissue Morcellator GA-0007500 || The Lumenis VersaCut / VersaCut+ Tissue Morcellator System is intended for use under direct or endoscopic visualization for the morcellation and removal of dissected tissue during pelviscopic, laparoscopic, percutaneous, and open surgical procedures whenever access to the surgical site is limited.

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En savoir plus sur les données ici

  • Adresse du fabricant
    Lumenis Limited, 13 Hayetzira St.,Yokneam Ind. Park, Yokneam Israel
  • Société-mère du fabricant (2017)
  • Source
    USFDA
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