Device Recall AlgiNot

  • Modèle / numéro de série
    ¿Product Part Numbers Lot Number  AlgiNot Intra Kit 34683 1-1017  AlgiNot Volume Refills 34682 1-1017
  • Classification du dispositif
  • Classe de dispositif
    2
  • Dispositif implanté ?
    No
  • Distribution
    Worldwide Distribution-USA (nationwide) and the countries of Canada, Europe, and Australia.
  • Description du dispositif
    The brand name of the device is AlgiNot, a dental impression material. || Product Part Numbers || AlgiNot Intra Kit 34683 || AlgiNot Volume Refills 34682 || Lot Number 1-1017 || AlgiNot is a Class II Medical Device. The device listing number this product is || 0136496 and the establishment registration number for Kerr Corporation is 1815757. || Intended as an alternative to traditional alginate materials.
  • Manufacturer
  • 1 Event

Fabricant

  • Adresse du fabricant
    Kerr Corporation, 28200 Wick Rd, Romulus MI 48174-2639
  • Société-mère du fabricant (2017)
  • Source
    USFDA