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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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28x44mm +3 Neutral Liner HXLPE
Ortho Development Corporation
170-2844
In Commercial Distribution

  • 00822409017522 ()

  • Length: 3 Millimeter
  • Lumen/Inner Diameter: 28 Millimeter
  • Outer Diameter: 44 Millimeter


  • Acetabular shell
28x46 +1 Hooded Liner HXLPE
Ortho Development Corporation
171-2846
In Commercial Distribution

  • 00822409017881 ()

  • Lumen/Inner Diameter: 28 Millimeter
  • Outer Diameter: 46 Millimeter
  • Length: 1 Millimeter


  • Acetabular shell
28x44 +3 Hooded Liner HXLPE
Ortho Development Corporation
171-2844
In Commercial Distribution

  • 00822409017874 ()

  • Length: 3 Millimeter
  • Outer Diameter: 44 Millimeter
  • Lumen/Inner Diameter: 28 Millimeter


  • Acetabular shell
The TriVascular® Ovation Prime® Abdominal Stent Graft System with the Ovation iX Iliac Stent Graft is an endovascular device delivered via a small diameter catheter to treat abdominal aortic aneurysms (AAAs). The stent graft is designed to reline the diseased vasculature, providing an endovascular blood conduit for isolating the aneurysm from the high pressure flow of blood, thereby reducing the risk of rupture. The stent graft is a modular configuration comprised of an aortic body section, iliac limbs, and iliac extensions as required. The TriVascular Ovation Prime Abdominal Stent Graft System with the Ovation iX Iliac Stent Graft includes, an Aortic Body Stent Graft and delivery catheter, Iliac Limb Stent Grafts and delivery catheters, Iliac Extension Stent Grafts and delivery catheters, as required, a Fill Polymer Kit, and an Autoinjector.
ENDOLOGIX, INC.
Iliac Extension
In Commercial Distribution

  • M701TVEX282845J1 ()

  • Catheter Gauge: 15 French
  • Length: 45 Millimeter
  • Outer Diameter: 28 Millimeter
TV-EX282845-J

  • Abdominal aorta endovascular stent-graft
Hemashield Platinum Woven 1 Branch Aortic Arch Double Velour Vascular Graft with Graft Sizer Accessory
INTERVASCULAR SAS
M00202175828P0
In Commercial Distribution

  • 00384401018575 ()

  • Lumen/Inner Diameter: 10 Millimeter
  • Lumen/Inner Diameter: 28 Millimeter
  • Length: 50 Centimeter
M00202175828P0

  • Synthetic vascular graft
DUET HEMODIALYSIS CATH, 10 FR. SL 28A/31V
Bard Access Systems, Inc.
5223280
Not in Commercial Distribution

  • 10801741011976 ()
  • 00801741011979 ()

  • Length: 31 Centimeter
  • Catheter Gauge: 10 French
  • Length: 28 Centimeter
5223280

  • Double-lumen haemodialysis catheter, implantable
14.5F x 28cm Vaxcel Plus Chronic Dialysis Catheter with Plastic Tunneler and 3 Introducer Needle Sizes
NAVILYST MEDICAL, INC.
45551
Not in Commercial Distribution

  • M001455510 ()

  • Catheter Gauge: 14.5 French
  • Length: 28 Centimeter
  • Outer Diameter: 4.8 Millimeter


  • Double-lumen haemodialysis catheter, implantable
14.5F x 28cm Vaxcel Plus Chronic Dialysis Catheter with Metal Tunneler and 3 Introducer Needle Sizes
NAVILYST MEDICAL, INC.
45550
Not in Commercial Distribution

  • M001455500 ()

  • Outer Diameter: 4.8 Millimeter
  • Length: 28 Centimeter
  • Catheter Gauge: 14.5 French


  • Double-lumen haemodialysis catheter, implantable
14.5F x 28cm Vaxcel Plus Chronic Dialysis Catheter with Plastic Tunneler
NAVILYST MEDICAL, INC.
45549
Not in Commercial Distribution

  • M001455490 ()

  • Catheter Gauge: 14.5 French
  • Length: 28 Centimeter
  • Outer Diameter: 4.8 Millimeter


  • Double-lumen haemodialysis catheter, implantable
14.5F x 28cm Vaxcel Plus Chronic Dialysis Catheter with Metal Tunneler
NAVILYST MEDICAL, INC.
45548
Not in Commercial Distribution

  • M001455480 ()

  • Length: 28 Centimeter
  • Catheter Gauge: 14.5 French
  • Outer Diameter: 4.8 Millimeter


  • Double-lumen haemodialysis catheter, implantable
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