Devices

Device Recall GYRUS ACMI PKS PlasmaSEAL Open Forceps

  • Modèle / numéro de série
    Catalog No. 2103PK and 917015PK all production codes
  • Classification du dispositif
    General and Plastic Surgery Devices
  • Classe de dispositif
    2
  • Dispositif implanté ?
    No
  • Distribution
    Nationwide, Australia, Canada, Netherlands. (AL, AR, AZ, CA, CO, CT, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, NE, NH, NJ, NM, NV, NY, OH, OK, PA, RI, SC, TN, TX, VA, WA, WI, WV).
  • Description du dispositif
    GYRUS ACMI PKS PlasmaSEAL Open Forceps, model 2103PK and 917015PK. Sterile EO. The device is intended to be used with the PlasmaKinetic electrosurgical generator, software version 1.93 or greater or the PlasmaKinetic with SuperPulse electrosurgical generator, software version 2.19A or greater or the G400 electrosurgical generator. Made in USA Gyrus ACMI, Gyrus Medical, Inc., 6655 Wedgwood Road, Suite 160, Maple Grove, MN 55311-3602.
  • Manufacturer
    Gyrus Medical, Inc.
  • 1 Event

Fabricant

Gyrus Medical, Inc.
  • Adresse du fabricant
    Gyrus Medical, Inc., 6655 Wedgewood Road, Suite 105, Maple Grove MN 55311
  • Source
    USFDA