Devices

Transhepatic Biliary Stent System

  • 모델명 / 제조번호(시리얼번호)
    Lot No's. 15530111, 15535366, 15556361, 15560541, 15562698, 15530115, 15536150, 15556366, 15560543, 15530114, 15556368, 15560545, 15562701, 15530113, 15556371, 15560546, 15530112, 15535365, 15556374, 15562702.
  • 의료기기 분류등급
    Gastroenterology-Urology Devices
  • 의료기기 등급
    2
  • 이식된 장치?
    Yes
  • 유통
    Worldwide Distribution-- USA (nationwide) and the country Canada.
  • 제품 설명
    Product is labeled in part: Inner Label "***S.M.A.R.T. Transhepatic Biliary Stent***REF Cat. No.***Lot No.***Use By***Cordis S.M.A.R.T. Nitinol Stent Transhepatic Biliary System***Assembled in Mexico***Cordis Corporation 14201 North West 60th Avenue Miami Lakes, Florida 33014, USA***Cordis S.M.A.R.T. TRANSHEPATIC BILIARY STENT***Cordis a Johnson & Johnson company***Endovascular***" || Catalog C06120MB Lot No's. 15530111, 15535366, 15556361, 15560541, 15562698. || Catalog C06150MB Lot No's. 15530115, 15536150, 15556366, 15560543. || Catalog C07120 MB Lot No's. 15530114, 15556368, 15560545, 15562701. || Catalog C07150MB Lot No's. 15530113, 15556371, 15560546. || Catalog C08120MB Lot No's. 15530112. || Catalog C08150MB Lot No's. 15535365, 15556374, 15562702. || Indicated for palliation of malignant neoplasms in the biliary tree.
  • Manufacturer
    Cordis Corporation
  • 1 Event

제조사

Cordis Corporation
  • 제조사 주소
    Cordis Corporation, 14201 Nw 60th Ave, Miami Lakes FL 33014-2802
  • 제조사 모회사 (2017)
    Cardinal Health
  • Source
    USFDA

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Transhepatic Biliary Stent System
  • 모델명 / 제조번호(시리얼번호)
    Lot No's. 15535360, 15530747, 15530756, 15530755, 15535363, 15569685, 15530757, 15530754, 15557313, 15530753, 15557311, 15535361.
  • 의료기기 분류등급
    Gastroenterology-Urology Devices
  • 의료기기 등급
    2
  • 이식된 장치?
    Yes
  • 유통
    Worldwide Distribution-- USA (nationwide) and the country Canada.
  • 제품 설명
    Product is labeled in part: Inner Label "***SMART Control Transhepatic Biliary Stent***REF Cat. No.***Lot No.***Use By***Cordis S.M.A.R.T. CONTROL Nitinol Stent Transhepatic Biliary System***Assembled in Mexico***Cordis Corporation 14201 North West 60th Avenue Miami Lakes, Florida 33014, USA***Cordis S.M.A.R.T. CONTROL BILIARY***Cordis a Johnson & Johnson company***Endovascular***" || Catalog C10080MB Lot No. 15535360. || Catalog C10080SB Lot No. 15530747. || Catalog C12030SB Lot No. 15530756. || Catalog C12040SB Lot No. 15530755. || Catalog C12060SB Lot No's. 15535363, 15569685. || Catalog C12080MB Lot No. 15530757 || Catalog C14040SB Lot No's. 15530754, 15557313. || Catalog C14060SB Lot No's. 15530753, 15557311. || Catalog C14080SB Lot No. 15535361. || Indicated for palliation of malignant neoplasms in the biliary tree.
  • Manufacturer
    Cordis Corporation
S.M.A.R.T. TRANSHEPATIC BILIARY STENT SYSTEM
  • 모델명 / 제조번호(시리얼번호)
    Model Catalog: C08120MB (Lot serial: >10 NUMBERS CONTACT MFR); Model Catalog: C07120MB (Lot serial: >10 NUMBERS CONTACT MFR); Model Catalog: C06150MB (Lot serial: >10 NUMBERS CONTACT MFR); Model Catalog: C06120MB (Lot serial: >10 NUMBERS CONTACT MFR); Model Catalog: C07150MB (Lot serial: >10 NUMBERS CONTACT MFR); Model Catalog: C08150MB (Lot serial: >10 NUMBERS CONTACT MFR)
  • 제품 설명
    S.M.A.R.T. TRANSHEPATIC BILIARY STENT
  • Manufacturer
    JOHNSON & JOHNSON MEDICAL PRODUCTS A DIV. OF JOHNSON & JOHNSON INC.