Device Recall MR GHIATAS Beaded Breast Localization Wire

  • 모델명 / 제조번호(시리얼번호)
    REYB1777 REZI0726 REZI0988 REZK0741 REZL0066 REAN0884
  • 의료기기 분류등급
  • 의료기기 등급
    1
  • 이식된 장치?
    No
  • 유통
    Worldwide Distribution - US Nationwide in the states of TX, FL, MO, NJ, WI, AL, TX, CA, OK, AZ, NC, GA, ID, WA, NY, NM and the countries of: Brazil, Canada, China, Taiwan, Canada, and Belgium.
  • 제품 설명
    MR GHIATAS Beaded Breast Localization Wire, Product Code: 477201, 479201 || Product Usage: || The GHIATAS Beaded Breast Localization Wire consists of an introducer needle and asemi-rigid localization wire that are intended for use during breast lesion surgery as a guidefor the surgeon to follow in the excision of the lesion. Product Codes 47020, 475201, 477201,479201, and 470201 do not have the ultrasound enhancement shown in Figure 1. In addition,Product Codes 475201, 477201, 479201, and 470201 may be placed under MRI guidance. || .
  • Manufacturer
  • 1 Event

제조사

  • 제조사 주소
    Bard Peripheral Vascular Inc, 1625 W 3rd St Bldg 1, Tempe AZ 85281-2438
  • 제조사 모회사 (2017)
  • Source
    USFDA