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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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APT 9 - 00887661375742

No Description
FGX INTERNATIONAL INC.
10238536.KHL
In Commercial Distribution

  • 00887661375742 ()


  • Tinted non-prescription spectacles

APT 9 - 00887661375711

No Description
FGX INTERNATIONAL INC.
10238534.KHL
In Commercial Distribution

  • 00887661375711 ()


  • Tinted non-prescription spectacles

APT 9 - 00887661375698

No Description
FGX INTERNATIONAL INC.
10238532.KHL
In Commercial Distribution

  • 00887661375698 ()


  • Tinted non-prescription spectacles

APT 9 - 00887661375674

No Description
FGX INTERNATIONAL INC.
10238530.KHL
In Commercial Distribution

  • 00887661375674 ()


  • Tinted non-prescription spectacles

APT 9 - 00887661375667

No Description
FGX INTERNATIONAL INC.
10238528.KHL
In Commercial Distribution

  • 00887661375667 ()


  • Tinted non-prescription spectacles

APT 9 - 00887661375650

No Description
FGX INTERNATIONAL INC.
10238527.KHL
In Commercial Distribution

  • 00887661375650 ()


  • Tinted non-prescription spectacles

External Fixator Connection 9 / 9 - 07640136270101

Element intended to become part of an assembly of non-sterile devices designed to stabilize fractured bones to promote treatment and healing. It typically consists of an external plastic and/or metallic fixator (a framework) and other external and/or implantable components such as clamps, rods, rings, pins, bolts, and nuts, as well as some reusable instrumentation (e.g., wrenches, depth gauge, tensioner). It is used mainly to help the healing of long bones such as the femur, tibia and humerus, as well as fractures of the foot and ankle, joint fusions, and limb lengthening. This is a single-use device intended to be sterilized prior to use.
GEXFIX SA
1010-1040
In Commercial Distribution

  • 07640136270101 ()


  • External orthopaedic fixation system, single-use

Cardiovascular Procedure Kit - 00699753525689

No Description
Terumo Cardiovascular Systems Corporation
CX-SA041X
In Commercial Distribution

  • 50699753525684 ()
  • 00699753525689 ()


  • Cardiopulmonary bypass system blood tubing set

FemTrak Femoral Venous Cannula - 00690103180138

Femoral Venous Cannula
Edwards Lifesciences LLC
FTV024
In Commercial Distribution

  • 00690103180138 ()

  • 24 Fr. (8.0 mm) x 68 cm (26.8")
FTV024

  • Cardiopulmonary bypass/extracorporeal membrane oxygenation cannula, drainage
  • Cardiopulmonary bypass cannula, femoral

FemTrak Femoral Venous Cannula - 00690103180121

Femoral Venous Cannula
Edwards Lifesciences LLC
FTV020
In Commercial Distribution

  • 00690103180121 ()

  • 20 Fr. (6.7 mm) x 55 cm (21.6")
FTV020

  • Cardiopulmonary bypass/extracorporeal membrane oxygenation cannula, drainage
  • Cardiopulmonary bypass cannula, femoral
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