Procedure Kit

  • 모델명 / 제조번호(시리얼번호)
    All lots prior to 09/14/2010 for Model Number 24-3050.
  • 의료기기 분류등급
  • 의료기기 등급
    1
  • 이식된 장치?
    No
  • 유통
    Worldwide distribution: USA (nationwide) including states of: AL, AR, CA, CO, CT, DC, CR FL,GA, HI, IA, IL, IN, KS, KY, LA, MA, MD,ME, MI MN, MO, MS, MT, NC, ND, NJ, NY, OH, O K, OR, PA, RI, SC, TN, TX, UT, VA and WA; and countries of: Argentina, Bahrain, Canada, Colombia, Costa Rica, and Finland.
  • 제품 설명
    "***REF: 24-3050 TMJ SYSTEM OnPoint SCOPE PROCEDURE KIT***STERILE PRODUCT***STERILE EO***KIT CONTAINS BOTH STERILE AND NON-STERILE COMPONENTS Distributed by: BIOMET MICROFIXATION 1520 TRADEPORT DRIVE JACKSONVILLE, FL 32218 USA www.biometmicrofixation.com***" || Kit Contains: Drape with pouch; 22g1.5in needle; OR towel; Towel clips; Skin marker with rule; Band-aids; Syringe pump tubing set; Cotton ball; 60ml syringe; Facial ice pack; Extension tubing; Chloraprep Swabsticks. || All-inclusive kit that alleviates the burden of piecing together each of the items necessary for a Arthroscopy using the OnPoint Scope.
  • Manufacturer
  • 1 Event

제조사

  • 제조사 주소
    Biomet Microfixation, Inc., 1520 Tradeport Dr, Jacksonville FL 32218-2480
  • 제조사 모회사 (2017)
  • 제조사 의견
    “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