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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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Stent - 00842429114285

FRED-X 21
MICROVENTION INC.
FREDX3032-PMA
In Commercial Distribution

  • 00842429114285 ()

  • 3.0 mm x 32 mm x 27 mm
FREDX3032

  • Bare-metal intracranial vascular stent

Stent - 00842429114254

FRED-X 21
MICROVENTION INC.
FREDX3013-PMA
In Commercial Distribution

  • 00842429114254 ()

  • 3.0 mm x 13 mm x 9 mm
FREDX3013

  • Bare-metal intracranial vascular stent

Stent - 00842429114230

FRED-X 21
MICROVENTION INC.
FREDX2525-PMA
In Commercial Distribution

  • 00842429114230 ()

  • 2.5 mm x 25 mm x 20 mm
FREDX2525

  • Bare-metal intracranial vascular stent

Stent - 00842429114223

FRED-X 21
MICROVENTION INC.
FREDX2518-PMA
In Commercial Distribution

  • 00842429114223 ()

  • 2.5 mm x 18 mm x 13 mm
FREDX2518

  • Bare-metal intracranial vascular stent

Stent - 00842429114216

FRED-X 21
MICROVENTION INC.
FREDX2513-PMA
In Commercial Distribution

  • 00842429114216 ()

  • 2.5 mm x 13 mm x 8 mm
FREDX2513

  • Bare-metal intracranial vascular stent

Stent - 00842429106587

FRED 21
MICROVENTION INC.
FRED2513-PMA
In Commercial Distribution

  • 00842429106587 ()

  • 2.5 mm x 18 mm x 13 mm
FRED2513

  • Bare-metal intracranial vascular stent

BLU-U® Blue Light Photodynamic Therapy Illuminator - M706417031

The 4170-3 is the Base Assembly component of the BLU-U® Blue Light Photodynamic Therapy Illuminator, Model 4170 (BLU-U). The BLU-U Head Assembly (4170-1) is assembled for use only with the BLU-U Post Assembly (4170-2) and the BLU-U Base Assembly (4170-3). The BLU-U is a compact light source designed to provide a uniform distribution the blue light. The BLU-U Head Assembly (4170-1) is mounted on a Post Assembly (4170-2) and a Base Assembly (4170-3). The BLU-U has a built-in power output monitoring and diagnostic system, as well as a system timer used to set the light dose delivered to a patient.
DUSA PHARMACEUTICALS INC.
4170-3
In Commercial Distribution

  • M706417031 ()
4170-3

  • Skin photodynamic therapy/phototherapy lamp

BLU-U® Blue Light Photodynamic Therapy Illuminator - M706417021

The 4170-2 is the Post Assembly component of the BLU-U® Blue Light Photodynamic Therapy Illuminator, Model 4170 (BLU-U). The BLU-U Head Assembly (4170-1) is assembled for use only with the BLU-U Post Assembly (4170-2) and the BLU-U Base Assembly (4170-3). The BLU-U is a compact light source designed to provide a uniform distribution the blue light. The BLU-U Head Assembly (4170-1) is mounted on a Post Assembly (4170-2) and a Base Assembly (4170-3). The BLU-U has a built-in power output monitoring and diagnostic system, as well as a system timer used to set the light dose delivered to a patient.
DUSA PHARMACEUTICALS INC.
4170-2
In Commercial Distribution

  • M706417021 ()
4170-2

  • Skin photodynamic therapy/phototherapy lamp

BLU-U® Blue Light Photodynamic Therapy Illuminator - M706417011

The 4170-1 is the Head Assembly component of the BLU-U® Blue Light Photodynamic Therapy Illuminator, Model 4170 (BLU-U). The BLU-U Head Assembly (4170-1) is assembled for use only with the BLU-U Post Assembly (4170-2) and the BLU-U Base Assembly (4170-3). The BLU-U is a compact light source designed to provide a uniform distribution the blue light. The BLU-U Head Assembly (4170-1) is mounted on a Post Assembly (4170-2) and a Base Assembly (4170-3). The BLU-U has a built-in power output monitoring and diagnostic system, as well as a system timer used to set the light dose delivered to a patient.
DUSA PHARMACEUTICALS INC.
4170-1
In Commercial Distribution

  • M706417011 ()
4170-1

  • Skin photodynamic therapy/phototherapy lamp

Ovation iX Iliac Stent Graft - M701TVIL142880J1

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 Limb
In Commercial Distribution

  • M701TVIL142880J1 ()

  • Catheter Gauge: 15 French
  • Length: 80 Millimeter
  • Outer Diameter: 28 Millimeter
  • Outer Diameter: 14 Millimeter
TV-IL142880-J

  • Abdominal aorta endovascular stent-graft
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