Green Mamba Suture Passer

  • Modèle / numéro de série
    Catalog Number: 110010850 Lot Number: 231120, 253210
  • Classification du dispositif
  • Classe de dispositif
    1
  • Dispositif implanté ?
    No
  • Distribution
    Nationwide Distribution-including the states of FL, NY, TX, VA, NV, MI, CA, IN, SD, GA, KY, NC, and AR.
  • Description du dispositif
    Green Mamba Suture Passer. || The Biomet Sports Medicine Mamba instruments are utilized to aid in passing suture through soft tissue. The Mamba Needle is designed for use with the Mamba Suture Passer. The needles are sterile, disposable, and for single-patient use only.
  • Manufacturer
  • 1 Event

Fabricant

  • Adresse du fabricant
    Biomet, Inc., 56 E Bell Dr, Warsaw IN 46581
  • Société-mère du fabricant (2017)
  • Commentaire du fabricant
    “The safety of patients has always been, and continues to be, Zimmer Biomet’s top priority and it is our honor to be a leader in this industry for the past 90 years,” Zimmer Biomet told ICIJ in a statement. “We adhere to strict regulatory standards, and work closely with the FDA and all applicable regulatory agencies in each of our regions as part of our commitment to operating a first-rate quality management system across our global manufacturing network. The company added that it is focused on staying at the forefront of innovation and doing right by the millions of patients who rely on the company’s products.
  • Source
    USFDA

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  • Modèle / numéro de série
    Catalog Number: 110010850 Lot Number Identification: 167890, 231120, 253210, 550050, 551580, 716300, 953230
  • Classification du dispositif
  • Classe de dispositif
    1
  • Dispositif implanté ?
    No
  • Distribution
    FL, NJ, WI, UT, TX, KY, KS, OH, GA, LA, AL, NY, NC, AR, MO, VA, CA, MN, IN, HI
  • Description du dispositif
    Green Mamba Suture Passer
  • Manufacturer