DUET TRS Loading Units

  • 모델명 / 제조번호(시리얼번호)
    Lot Numbers: N0A0069U N0C0585 N0C0609 N0F0292 N0F0325 N0G0257 N1B0092 N1C0937 N1E0231X N9K0712U N9K0715U N9K0717U N9M0411UR
  • 의료기기 분류등급
  • 의료기기 등급
    2
  • 이식된 장치?
    Yes
  • 유통
    Worldwide distribution: USA (nationwide) and countries of: Asia, Australia, Canada, Europe, Japan, Latin America, and Pacific.
  • 제품 설명
    DUET TRS 45 3.5mm Universal Straight Single Use Loading Unit Surgical Stapler with Implantable Staples || Reference Number: DUET4535 || The ENDO GIA Universal Staplers with DUET TRS Loading Unit have applications in abdominal, gynecologic, pediatric and thoracic surgery for resection, transection, and creation of anastomosis. They may be used for transection and resection of liver substance, hepatic vasculature and biliary structures.
  • Manufacturer
  • 1 Event

제조사

  • 제조사 주소
    Covidien LP, 60 Middletown Ave, North Haven CT 06473-3908
  • 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

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  • 모델명 / 제조번호(시리얼번호)
  • 제품 설명
    Medical instruments for use in humans - general instruments
  • Manufacturer
  • 모델명 / 제조번호(시리얼번호)
    Lot Numbers: H0B0005U H0C0050 H0H0007 H0J0014 N0A0026U N0A0548U N0A0757U N0B0073U N0B0284U N0B0742 N0B0773 N0C0182 N0C0257 N0C0611 N0C0776 N0D0203 N0D0237 N0D0419 N0D0611 N0D0792 N0E0168 N0F0031 N0F0334 N0F0526 N0F0621 N0G0433 N0G0699 N0H0309 N0H0402 N0H0743 N0J0261 N0J0327 N0J0451 N0K0227 N0K0773 N0L0111 N0L0310 N0M0069L N0M0339L N0M0385L N0M0595L N1A0258L N1A0371L N1B0329L N1B0632L N1C0928L N1D0088L N9C0355U N9C0356U N9C0357U N9C0428U N9C0429U N9C0430U N9C1032U N9D0033U N9D0034U N9D0829U N9D0830U N9D0831U N9D0832U N9D0888U N9D0889U N9D0890U N9D0891U N9D0951U N9E0117U N9E0118U N9E0119U N9E0479U N9E0638U N9E0640U N9E0642U N9F0052UR N9F0768U N9G0425U N9G0792U N9G0793U N9H0396U N9H0397U N9J0030U N9J0282U N9J0531U N9K0164U N9K0452U N9K0663U N9L0341U N9L0536U N9L0558U N9M0056U N9M0352U U9B101 U9B64 U9B82
  • 의료기기 분류등급
  • 의료기기 등급
    2
  • 이식된 장치?
    Yes
  • 유통
    Worldwide distribution: USA (nationwide) and countries of: Asia, Australia, Canada, Europe, Japan, Latin America, and Pacific.
  • 제품 설명
    DUET TRS 45 3.5mm Universal Articulating Single Use Loading Unit Surgical Stapler with Implantable Staples || Reference Number: DUET4535A || The ENDO GIA Universal Staplers with DUET TRS Loading Unit have applications in abdominal, gynecologic, pediatric and thoracic surgery for resection, transection, and creation of anastomosis. They may be used for transection and resection of liver substance, hepatic vasculature and biliary structures.
  • Manufacturer
  • 모델명 / 제조번호(시리얼번호)
    Lot Numbers: N0G0339 N0G0781 N0H0015 N0H0437 N1E0545XR N9E0810U N9E0811U N9E0812U N9K0078U N9K0079U
  • 의료기기 분류등급
  • 의료기기 등급
    2
  • 이식된 장치?
    Yes
  • 유통
    Worldwide distribution: USA (nationwide) and countries of: Asia, Australia, Canada, Europe, Japan, Latin America, and Pacific.
  • 제품 설명
    DUET TRS 45 4.8mm Universal Straight Single Use Loading Unit Surgical Stapler with Implantable Staples || Reference Number: DUET4548 || The ENDO GIA Universal Staplers with DUET TRS Loading Unit have applications in abdominal, gynecologic, pediatric and thoracic surgery for resection, transection, and creation of anastomosis. They may be used for transection and resection of liver substance, hepatic vasculature and biliary structures.
  • Manufacturer
  • 모델명 / 제조번호(시리얼번호)
    Lot Numbers: H0F0046 H0J0067 H1B0022 N0A0005U N0A0070U N0A0123U N0A0350U N0B0025U N0B0173U N0B0658 N0C0207 N0C0212 N0C0394 N0C0500 N0C0742 N0C0893 N0D0219 N0D0321 N0D0573 N0D0750 N0E0200 N0E0549 N0E0640 N0F0099 N0F0501 N0G0057 N0G0403 N0H0146 N0H0511 N0H0641 N0H0755 N0J0216 N0J0568 N0K0181 N0K0333 N0K0466 N0K0553 N0L0563L N0M0243L N1A0154L N1A0216L N1B0136L N1D0146L N1D0147L N1D0518LX N1D0682LX N1E0284LX N1F0028LX N9D0672U N9D0819U N9D0820U N9D0821U N9E0176UR N9E0310U N9E0311U N9E0643U N9E0645U N9F0053UR N9F0256U N9F0257U N9F0339U N9F0518U N9F0543U N9F0544U N9F0547U N9F0558U N9F0743U N9F0820U N9G0233U N9G0331U N9G0332U N9G0566U N9G0567U N9G0722U N9G0723U N9G0815U N9H0114U N9H0115U N9H0145U N9H0197U N9H0403U N9H0404U N9H0429U N9H0430U N9H0431U N9H0531U N9H0532U N9H0538U N9H0596U N9J0002U N9K0138U N9L0526U N9M0350U N9M0590U
  • 의료기기 분류등급
  • 의료기기 등급
    2
  • 이식된 장치?
    Yes
  • 유통
    Worldwide distribution: USA (nationwide) and countries of: Asia, Australia, Canada, Europe, Japan, Latin America, and Pacific.
  • 제품 설명
    DUET TRS 45 4.8mm Universal Articulating Single Use Loading Unit Surgical Stapler with Implantable Staples || Reference Number: DUET4548A || The ENDO GIA Universal Staplers with DUET TRS Loading Unit have applications in abdominal, gynecologic, pediatric and thoracic surgery for resection, transection, and creation of anastomosis. They may be used for transection and resection of liver substance, hepatic vasculature and biliary structures.
  • Manufacturer
  • 모델명 / 제조번호(시리얼번호)
    Lot Numbers: N0A0278U N0A0597U N0A0603U N0C0403 N0C0405 N0C0439 N0E0113 N0E0423 N0E0426 N0F0426 N0F0446 N0G0266 N0G0279 N0G0557 N0H0123 N0L0372 N0L0400 N1A0928 N1A0930 N1C0009 N1C0048 N1E0182X N1E0932X N1G0241X N9E0801U N9E0802U N9E0803U N9H0598U N9M0251U
  • 의료기기 분류등급
  • 의료기기 등급
    2
  • 이식된 장치?
    Yes
  • 유통
    Worldwide distribution: USA (nationwide) and countries of: Asia, Australia, Canada, Europe, Japan, Latin America, and Pacific.
  • 제품 설명
    DUET TRS 60 3.5mm Universal Straight Single Use Loading Unit Surgical Stapler with Implantable Staples || Reference Number: DUET6035 || The ENDO GIA Universal Staplers with DUET TRS Loading Unit have applications in abdominal, gynecologic, pediatric and thoracic surgery for resection, transection, and creation of anastomosis. They may be used for transection and resection of liver substance, hepatic vasculature and biliary structures.
  • Manufacturer
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