Device Recall Gyrus ACMI Disposable FalopeRing Band Applicator Kits

  • Modèle / numéro de série
    Lots: MK761655, MK764022, MK767655, MK526401
  • Classification du dispositif
  • Classe de dispositif
    3
  • Dispositif implanté ?
    Yes
  • Distribution
    US Distribution.
  • Description du dispositif
    Gyrus ACMI Disposable Falope-Ring Band Applicator Kits. REF 006889-901 and REF 005280-901 (with 8 mm Disposable Trocan). Sterile EO. Single Use Only. || The disposable Falope-Ring Band Applicator is a sterile, two-band, dual-incision instrument. The two-band applicator enables the physician to occlude both Fallopian tubes without removing the applicator from the abdominal cavity. The Falope-Ring Band and Applicator Kits are indicated for use for female sterilization (permanent contraception).
  • Manufacturer
  • 1 Event

Fabricant

  • Adresse du fabricant
    Gyrus Medical, Inc, 6655 Wedgwood Rd N Ste 160, Osseo MN 55311-3613
  • Société-mère du fabricant (2017)
  • Source
    USFDA