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Company Name Brand Name GMDN Term Name GMDN Term Status FDA Product Code Name FDA Product Code Device Packaged As Sterile Sterilization Prior To Use Issuing Agency Device Size Device Size Type Device Class Implantable

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The EndoGI Specialized S-Path Biliary Delivery System is designed for the deployment of Pigtail Biliary stent enabling drainage for the treatment of biliary and pancreatic ducts stenosis and strictures. The EndoGI S-Path Delivery System enables insertion and placement of one stent in the common bile and hepatic ducts with one passage of the delivery system while securing and maintaining access of the guidewire at the targeted deployment site. The EndoGI Specialized S-Path Biliary Delivery System is to be loaded with a compatible pigtail stent prior to use. The system is compatible with a 10Fr (2.4 mm inner diameter and 3.4mm outer diameter) pigtail stent with a length of 7 cm (total length up to 20 cm).
ENDO GI MEDICAL LTD
Delivery System
In Commercial Distribution

  • 00860005738243 ()


  • Polymeric biliary stent, non-bioabsorbable
Topical Skin Adhesive Clear
TISSUE SEAL L.L.C.
TS1050071-FP
In Commercial Distribution

  • 10860000589021 ()
  • 00860000589024 ()

  • Total Volume: 0.5 Milliliter
TS1050071-FP

  • Skin-approximation adhesive
No Description
Merit Medical Systems, Inc.
00884450414750
In Commercial Distribution

  • 10884450414757 ()
  • 00884450414750 ()

  • French Size (F)-14F
RBC-14-REV/A

  • Biliary drain
No Description
Merit Medical Systems, Inc.
00884450399361
In Commercial Distribution

  • 10884450399368 ()
  • 00884450399361 ()

  • Balloon Length-5.5 cm
  • Balloon Outer Diameters-8 mm, 9 mm, 10 mm
  • Catheter Length-180 cm
  • Catheter Length-180 cm; Balloon Length-5.5 cm; Balloon Outer Diameters-8 mm, 9 mm, 10 mm; Catheter Length-180 cm
  • Balloon Outer Diameters-8 mm, 9 mm, 10 mm; Balloon Length-5.5 cm; Balloon Outer Diameters-8 mm, 9 mm, 10 mm; Catheter Length-180 cm
EPB8/A

  • Gastrointestinal/biliary dilation balloon catheter, non-medicated
No Description
Merit Medical Systems, Inc.
00884450399354
In Commercial Distribution

  • 10884450399351 ()
  • 00884450399354 ()

  • Balloon Outer Diameters-6 mm, 7 mm, 8 mm
  • Catheter Length-180 cm
  • Balloon Length-5.5 cm
  • Balloon Length-5.5 cm; Balloon Outer Diameters-6 mm, 7 mm, 8 mm; Catheter Length-180 cm; Balloon Length-5.5 cm
  • Catheter Length-180 cm; Balloon Outer Diameters-6 mm, 7 mm, 8 mm; Catheter Length-180 cm; Balloon Length-5.5 cm
EPB6/A

  • Gastrointestinal/biliary dilation balloon catheter, non-medicated
No Description
Merit Medical Systems, Inc.
00884450458648
In Commercial Distribution

  • 20884450458642 ()
  • 10884450458645 ()
  • 00884450458648 ()
RCXB7-10-038/A

  • Polymeric biliary stent, non-bioabsorbable
No Description
Merit Medical Systems, Inc.
00884450442746
In Commercial Distribution

  • 10884450442743 ()
  • 00884450442746 ()
RCXB15-10-038

  • Polymeric biliary stent, non-bioabsorbable
No Description
Merit Medical Systems, Inc.
00884450442739
In Commercial Distribution

  • 10884450442736 ()
  • 00884450442739 ()
RCXB10-10-038

  • Polymeric biliary stent, non-bioabsorbable
No Description
Merit Medical Systems, Inc.
00884450442722
In Commercial Distribution

  • 10884450442729 ()
  • 00884450442722 ()
RCXB7-10-038

  • Polymeric biliary stent, non-bioabsorbable
No Description
Merit Medical Systems, Inc.
00884450442715
In Commercial Distribution

  • 10884450442712 ()
  • 00884450442715 ()
RCXB5-10-038

  • Polymeric biliary stent, non-bioabsorbable
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