Endo GIA" Auto Suture" Universal Articulating Loading Unit

  • 모델명 / 제조번호(시리얼번호)
    Lot: N7G0796KX & N7L0818KX
  • 의료기기 분류등급
  • 의료기기 등급
    2
  • 이식된 장치?
    Yes
  • 유통
    Worldwide and US Nationwide
  • 제품 설명
    Endo GIA" 45mm Gray Curved Tip Articulating Vascular Reload with Tri-Staple" Technology( Item Code EGIA45CTAV) || Product Usage: || The Endo GIA universal and Endo GIA universal XL staplers place two, triple-staggered rows of titanium staples and simultaneously divides the tissue between the two, triple-staggered rows. The size of the staples is determined by the selection of the 2.0 mm, 2.5 mm, 3.5 mm or 4.8 mm single use loading unit. The Endo GIA universal staplers will accommodate any of the single use loading unit sizes that are available in the 30 mm, 45 mm and 60 mm lines.
  • Manufacturer
  • 1 Event

제조사

  • 제조사 주소
    COVIDIEN MEDTRONIC, 60 NIDDLETOWN AVE 2ND F, NORTH HAVEN CT 06473
  • 제조사 모회사 (2017)
  • 제조사 의견
    “If our surveillance systems identify a potential performance issue, our personnel promptly evaluate the problem, including, when appropriate, conducting root cause investigations and internal testing to assess whether the product continues to meet specifications and defined performance criteria,” Medtronic told ICIJ in a statement. “In some cases, based on this evaluation, Medtronic may determine that a recall is necessary.” The company said that it communicates with healthcare providers and/or patients and provide recommendations to address such issues. Medtronic noted that these communications can include letters, emails, calls, press releases, physician notifications and social media postings, as well as informing the FDA and other regulators of the actions.
  • Source
    USFDA

유사한 이름을 가진 의료기기 1건 유사한 이름을 가진 의료기기 9 건

데이터에 대해 더 자세히 알아보기 여기

  • 모델명 / 제조번호(시리얼번호)
    Lots: N7L0071KX, N7L0527KX, N7L0792KX, N7L0914KX, N7L1014KX, N7L1159KX, N8A0154KX,N8A0553KX, N8A0850KX, N8C0830KX, N8C0847KRX, N8C0848KRX  GTIN # 1 (Inner Carton) - 10884523002829 GTIN # 2 (Outer Carton)- 20884523002826
  • 의료기기 분류등급
  • 의료기기 등급
    2
  • 이식된 장치?
    Yes
  • 유통
    Worldwide and US Nationwide
  • 제품 설명
    Endo GIA" Auto Suture" Universal Articulating Loading Unit 30mm - 2.5mm ( Item Code 030451) || Product Usage: || The Endo GIA universal and Endo GIA universal XL staplers place two, triple-staggered rows of titanium staples and simultaneously divides the tissue between the two, triple-staggered rows. The size of the staples is determined by the selection of the 2.0 mm, 2.5 mm, 3.5 mm or 4.8 mm single use loading unit. The Endo GIA universal staplers will accommodate any of the single use loading unit sizes that are available in the 30 mm, 45 mm and 60 mm lines.
  • Manufacturer
  • 모델명 / 제조번호(시리얼번호)
    Lots: N7L0306KX, N7M0221KX, N8B0724KX, N8C0958KX, N8C1303KRX GTIN # 1 (Inner Carton) -GTIN #1 10884523002812 GTIN # 2 (Outer Carton)- GTIN # 2 20884523002819
  • 의료기기 분류등급
  • 의료기기 등급
    2
  • 이식된 장치?
    Yes
  • 유통
    Worldwide and US Nationwide
  • 제품 설명
    Endo GIA" Auto Suture" Universal Articulating Loading Unit 30mm- 2.0mm ( Item Code 030450) || Product Usage: || The Endo GIA universal and Endo GIA universal XL staplers place two, triple-staggered rows of titanium staples and simultaneously divides the tissue between the two, triple-staggered rows. The size of the staples is determined by the selection of the 2.0 mm, 2.5 mm, 3.5 mm or 4.8 mm single use loading unit. The Endo GIA universal staplers will accommodate any of the single use loading unit sizes that are available in the 30 mm, 45 mm and 60 mm lines.
  • Manufacturer
  • 모델명 / 제조번호(시리얼번호)
    Lots: N7L0191KX, N7M0944KX, N8B0234KX,N8C0147KX  GTIN # 1 (Inner Carton) - 10884523002836 GTIN # 2 (Outer Carton)- 20884523002833
  • 의료기기 분류등급
  • 의료기기 등급
    2
  • 이식된 장치?
    Yes
  • 유통
    Worldwide and US Nationwide
  • 제품 설명
    Endo GIA" Auto Suture" Universal Articulating Loading Unit 30mm - 3.5mm ( Item Code 030452) || Product Usage: || The Endo GIA universal and Endo GIA universal XL staplers place two, triple-staggered rows of titanium staples and simultaneously divides the tissue between the two, triple-staggered rows. The size of the staples is determined by the selection of the 2.0 mm, 2.5 mm, 3.5 mm or 4.8 mm single use loading unit. The Endo GIA universal staplers will accommodate any of the single use loading unit sizes that are available in the 30 mm, 45 mm and 60 mm lines.
  • Manufacturer
  • 모델명 / 제조번호(시리얼번호)
    Lots: N7K1146KX, N7L0355KX, N7L1119KX, N7M0088KX, N7M0343KX, N7M0477KRX, N7M0509KX, N7M0520KX, N7M0521KX, N8A0312KRX, N8A0360KX, N8A0433KX, N8A0434KX, N8A0435KX, N8B0487KX, N8C0026KX, N8C0119KX, N8C0630KX  GTIN # 1 (Inner Carton) - 10884523002850 GTIN # 2 (Outer Carton)- 20884523002857
  • 의료기기 분류등급
  • 의료기기 등급
    2
  • 이식된 장치?
    Yes
  • 유통
    Worldwide and US Nationwide
  • 제품 설명
    Endo GIA" Auto Suture" Universal Articulating Loading Unit 45mm - 2.5mm( Item Code 030454) || Product Usage: || The Endo GIA universal and Endo GIA universal XL staplers place two, triple-staggered rows of titanium staples and simultaneously divides the tissue between the two, triple-staggered rows. The size of the staples is determined by the selection of the 2.0 mm, 2.5 mm, 3.5 mm or 4.8 mm single use loading unit. The Endo GIA universal staplers will accommodate any of the single use loading unit sizes that are available in the 30 mm, 45 mm and 60 mm lines.
  • Manufacturer
  • 모델명 / 제조번호(시리얼번호)
    Lots: N7F0576KX, N7L0032KX, N7L0239KX, N7L0519KX, N7M0104KX, N7M0383KX, N7M0584KX, N7M0696KX, N8A0036KX, N8A0324KX, N8A0477KRX, N8A0551KX, N8C0357KX  GTIN # 1 (Inner Carton) - 10884523002867 GTIN # 2 (Outer Carton)- 20884523002864
  • 의료기기 분류등급
  • 의료기기 등급
    2
  • 이식된 장치?
    Yes
  • 유통
    Worldwide and US Nationwide
  • 제품 설명
    Endo GIA" Auto Suture" Universal Articulating Loading Unit 45mm- 3.5mm( Item Code 030455) || Product Usage: || The Endo GIA universal and Endo GIA universal XL staplers place two, triple-staggered rows of titanium staples and simultaneously divides the tissue between the two, triple-staggered rows. The size of the staples is determined by the selection of the 2.0 mm, 2.5 mm, 3.5 mm or 4.8 mm single use loading unit. The Endo GIA universal staplers will accommodate any of the single use loading unit sizes that are available in the 30 mm, 45 mm and 60 mm lines.
  • Manufacturer
하나 더 4 건 더