Devices

Device Recall Gyrus ACMI Diego Elite Tubeset

  • Model / Serial
    Lot Number: JC24165
  • Product Classification
    General and Plastic Surgery Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Nationwide and Canada, Australia, Germany, New Zealand, Japan, India, Great Britain
  • Product Description
    Gyrus ACMI Diego Elite Tubeset, intended for cutting, coagulation, drilling, debriding, and removal of bone, and soft and hard tissue in general ENT, Sinus/Rhinology, Nasopharyngeal/Laryngology, and Head and Neck procedures. Catalog No. TS101DC, Lot numbers JC924165 and below; Rx Only, STERILE EO
  • Manufacturer
    Gyrus Acmi, Incorporated
  • 1 Event

Manufacturer

Gyrus Acmi, Incorporated
  • Manufacturer Address
    Gyrus Acmi, Incorporated, 136 Turnpike Road, Southborough MA 01772-2118
  • Manufacturer Parent Company (2017)
    Olympus Corporation
  • Source
    USFDA

One device with a similar name

Learn more about the data here

Device Recall Gyrus ACMI Diego Elite Tubeset
  • Model / Serial
    Lot number: JC929332
  • Product Classification
    General and Plastic Surgery Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Nationwide and Canada, Australia, Germany, New Zealand, Japan, India, Great Britain
  • Product Description
    Gyrus ACMI Diego Elite Tubeset; intended for cutting, coagulation, drilling, debriding, and removal of bone, and soft and hard tissue in general ENT, Sinus/Rhinology, Nasopharyngeal/Laryngology, and Head & Neck procedures. Catalog No. TS100S, Lot numbers JC929332 and below, Rx Only, STERILE EO
  • Manufacturer
    Gyrus Acmi, Incorporated