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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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Dimensions: 50 x 50 x 1.25 mm Material: PCL Intended Use: The Osteopore PCL Scaffold Bone Filler is intended for use in the repair of neurosurgical burr holes, craniotomy cuts and other cranial defects. It is also for use in the augmentation or restoration of bony contour in the craniofacial skeleton. It should be gently packed into bony voids or gaps of the skeletal system.
OSTEOPORE INTERNATIONAL PTE. LTD.
PC11(50,50,1.25)
In Commercial Distribution

  • 08885013200126 ()

  • Height: 1.25 Millimeter
  • Width: 50 Millimeter
  • Length: 50 Millimeter


  • Bone matrix implant, synthetic, non-antimicrobial
Dimensions: 50 x 50 x 1 mm Material: PCL Intended Use: The Osteopore PCL Scaffold Bone Filler is intended for use in the repair of neurosurgical burr holes, craniotomy cuts and other cranial defects. It is also for use in the augmentation or restoration of bony contour in the craniofacial skeleton. It should be gently packed into bony voids or gaps of the skeletal system.
OSTEOPORE INTERNATIONAL PTE. LTD.
PC11(50,50,1)
In Commercial Distribution

  • 08885013200119 ()

  • Height: 1 Millimeter
  • Width: 50 Millimeter
  • Length: 50 Millimeter


  • Bone matrix implant, synthetic, non-antimicrobial
Dimensions: 25 x 25 x 1 mm Material: PCL Intended Use: The Osteopore PCL Scaffold Bone Filler is intended for use in the repair of neurosurgical burr holes, craniotomy cuts and other cranial defects. It is also for use in the augmentation or restoration of bony contour in the craniofacial skeleton. It should be gently packed into bony voids or gaps of the skeletal system.
OSTEOPORE INTERNATIONAL PTE. LTD.
PC11(25,25,1)
In Commercial Distribution

  • 08885013200041 ()

  • Length: 25 Millimeter
  • Width: 25 Millimeter
  • Depth: 1 Millimeter


  • Bone matrix implant, synthetic, non-antimicrobial
The DETOUR System is indicated for use for percutaneous revascularization in patients with symptomatic femoropopliteal lesions from 200 mm to 460 mm in length with chronic total occlusions (100 mm to 425 mm) or diffuse stenosis >70% who may be considered suboptimal candidates for surgical or alternative endovascular treatments. The DETOUR System, or any of its components, is not for use in the coronary and cerebral vasculature
PQ Bypass, Inc.
TSG-6.7X200
In Commercial Distribution

  • 00860008946478 ()

  • 6.7mm Stent Graft Proximal Diameter
  • 6.7mm Stent Graft Distal Diameter
  • 135cm Catheter Working Length
  • 8F Delivery System Outer Profile
  • 200mm Covered Stent Graft Length
TSG-6.7X200

  • Central/peripheral venous endovascular stent-graft
The DETOUR System is indicated for use for percutaneous revascularization in patients with symptomatic femoropopliteal lesions from 200 mm to 460 mm in length with chronic total occlusions (100 mm to 425 mm) or diffuse stenosis >70% who may be considered suboptimal candidates for surgical or alternative endovascular treatments. The DETOUR System, or any of its components, is not for use in the coronary and cerebral vasculature
PQ Bypass, Inc.
TSG-6.7X150
In Commercial Distribution

  • 00860008946461 ()

  • 6.7mm Stent Graft Proximal Diameter
  • 6.7mm Stent Graft Distal Diameter
  • 135cm Catheter Working Length
  • 8F Delivery System Outer Profile
  • 150mm Covered Stent Graft Length
TSG-6.7X150

  • Central/peripheral venous endovascular stent-graft
The DETOUR System is indicated for use for percutaneous revascularization in patients with symptomatic femoropopliteal lesions from 200 mm to 460 mm in length with chronic total occlusions (100 mm to 425 mm) or diffuse stenosis >70% who may be considered suboptimal candidates for surgical or alternative endovascular treatments. The DETOUR System, or any of its components, is not for use in the coronary and cerebral vasculature
PQ Bypass, Inc.
TSG-6.7X100
In Commercial Distribution

  • 00860008946454 ()

  • 6.7mm Stent Graft Proximal Diameter
  • 6.7mm Stent Graft Distal Diameter
  • 135cm Catheter Working Length
  • 8F Delivery System Outer Profile
  • 100mm Covered Stent Graft Length
TSG-6.7X100

  • Central/peripheral venous endovascular stent-graft
The DETOUR System is indicated for use for percutaneous revascularization in patients with symptomatic femoropopliteal lesions from 200 mm to 460 mm in length with chronic total occlusions (100 mm to 425 mm) or diffuse stenosis >70% who may be considered suboptimal candidates for surgical or alternative endovascular treatments. The DETOUR System, or any of its components, is not for use in the coronary and cerebral vasculature
PQ Bypass, Inc.
TSG-6.0X200
In Commercial Distribution

  • 00860008946447 ()

  • 6.0 mm Stent Graft Proximal Diameter
  • 6.0 mm Stent Graft Distal Diameter
  • 135cm Catheter Working Length
  • 6F Delivery System Outer Profile
  • 200mm Covered Stent Graft Length
TSG-6.0X200

  • Central/peripheral venous endovascular stent-graft
The DETOUR System is indicated for use for percutaneous revascularization in patients with symptomatic femoropopliteal lesions from 200 mm to 460 mm in length with chronic total occlusions (100 mm to 425 mm) or diffuse stenosis >70% who may be considered suboptimal candidates for surgical or alternative endovascular treatments. The DETOUR System, or any of its components, is not for use in the coronary and cerebral vasculature
PQ Bypass, Inc.
TSG-6.0X150
In Commercial Distribution

  • 00860008946430 ()

  • 6.0mm Stent Graft Proximal Diameter
  • 6.0mm Stent Graft Distal Diameter
  • 135cm Catheter Working Length
  • 8F Delivery System Outer Profile
  • Covered Stent Graft Length
TSG-6.0X150

  • Central/peripheral venous endovascular stent-graft
The DETOUR System is indicated for use for percutaneous revascularization in patients with symptomatic femoropopliteal lesions from 200 mm to 460 mm in length with chronic total occlusions (100 mm to 425 mm) or diffuse stenosis >70% who may be considered suboptimal candidates for surgical or alternative endovascular treatments. The DETOUR System, or any of its components, is not for use in the coronary and cerebral vasculature
PQ Bypass, Inc.
TSG-6.0X100
In Commercial Distribution

  • 00860008946423 ()

  • 6.0 mm Stent Graft Proximal Diameter
  • 6.0 mm Stent Graft Distal Diameter
  • 135cm Catheter Working Length
  • 8F Delivery System Outer Profile
  • 100 mm Covered Stent Graft Length
TSG-6.0X100

  • Central/peripheral venous endovascular stent-graft
The DETOUR System is indicated for use for percutaneous revascularization in patients with symptomatic femoropopliteal lesions from 200 mm to 460 mm in length with chronic total occlusions (100 mm to 425 mm) or diffuse stenosis >70% who may be considered suboptimal candidates for surgical or alternative endovascular treatments. The DETOUR System, or any of its components, is not for use in the coronary and cerebral vasculature
PQ Bypass, Inc.
TSG-5.5X200
In Commercial Distribution

  • 00860008946416 ()

  • 5.5 mm Stent Graft Proximal Diameter
  • 5.5 mm Stent Graft Distal Diameter
  • 135cm Catheter Working Length
  • 8F Delivery System Outer Profile
  • 200 mm Covered Stent Graft Length
TSG-5.5X200

  • Central/peripheral venous endovascular stent-graft
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