Device Recall DeRoyal(R) TRAUMA CRANIOTOMY PACK

  • Modèle / numéro de série
    REF 89-7639.01 - Lot Number 24579045  REF 89-7639.01 - Lot Number 24664258  REF 89-7639.02 - Lot Numbers: 24828048, 25598985, 25359212, 25399676
  • Classification du dispositif
  • Classe de dispositif
    1
  • Dispositif implanté ?
    No
  • Distribution
    (USA) including Indiana
  • Description du dispositif
    Custom surgical kits: || DeRoyal(R) TRAUMA CRANIOTOMY PACK, REF 89-7639.01, STERILE EO, Manufactured by: DeRoyal Industries, Inc., Powell, TN 37849 || DeRoyal(R) TRAUMA CRANIOTOMY PACK PGYBK, REF 89-7639.01, STERILE EO, Manufactured by: DeRoyal Industries, Inc., Powell, TN 37849 || DeRoyal(R) TRAUMA CRANIOTOMY PACK PGYBK, REF 89-7639.02, STERILE EO, Manufactured by: DeRoyal Industries, Inc., Powell, TN 37849 || surgical kits
  • Manufacturer
  • 1 Event

Fabricant

  • Adresse du fabricant
    DeRoyal Processing Center, 1703 Highway 33 S, New Tazewell TN 37825-5043
  • Société-mère du fabricant (2017)
  • Source
    USFDA