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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FEM-FLEX II Femoral Arterial Cannula
Edwards Lifesciences LLC
FEMII014AT
In Commercial Distribution

  • 00690103031195 ()
  • 50690103031190 ()

  • 14 Fr. (4.7 mm) x 6.5 cm (2.6")
FEMII014AT

  • Cardiopulmonary bypass/extracorporeal membrane oxygenation cannula, drainage
  • Cardiopulmonary bypass cannula, femoral
15 Fr x 17 cm femoral arterial cannula with 10 Fr introducer
CARDIACASSIST, INC.
5130-1715
In Commercial Distribution

  • 00814112020111 ()
5130-1715

  • Cardiopulmonary bypass cannula, femoral
  • Cardiopulmonary bypass/extracorporeal membrane oxygenation cannula, return
eSensor® Warfarin Sensitivity Test Amplification Reagents (24)
GENMARK DIAGNOSTICS, INC.
Warfarin Sensitivity Test (WST)
Not in Commercial Distribution

  • 00857167005245 ()
MT002001

  • Cytochrome P450 (CYP450) gene polymorphism IVD, kit, multiplex
eSensor® Cystic Fibrosis (CF) Genotyping Test (24)
GENMARK DIAGNOSTICS, INC.
eSensor® Cystic Fibrosis (CF)
Not in Commercial Distribution

  • 00857167005153 ()
MT002015

  • Cystic fibrosis IVD, kit, multiplex
eSensor® Warfarin Sensitivity Test Cartridges (WST) (24)
GENMARK DIAGNOSTICS, INC.
Warfarin Sensitivity Test (WST)
Not in Commercial Distribution

  • 00857167005061 ()
MT002000

  • Cytochrome P450 (CYP450) gene polymorphism IVD, kit, multiplex
Lag Screw (cannulated polyaxial) - 4.0 x 24 mm
EXTREMITY MEDICAL, LLC
118-40124
In Commercial Distribution

  • M78011840124 ()


  • Orthopaedic bone screw, non-bioabsorbable, non-sterile
Lag Screw (cannulated tapered) - 4.0 x 24 mm
EXTREMITY MEDICAL, LLC
118-40024
In Commercial Distribution

  • M78011840024 ()


  • Orthopaedic bone screw, non-bioabsorbable, non-sterile
Lag Screw (solid polyaxial) - 3.0 x 24 mm
EXTREMITY MEDICAL, LLC
118-30124
In Commercial Distribution

  • M78011830124 ()


  • Orthopaedic bone screw, non-bioabsorbable, non-sterile
Lag Screw (solid tapered) - 3.0 x 24 mm
EXTREMITY MEDICAL, LLC
118-30024
In Commercial Distribution

  • M78011830024 ()


  • Orthopaedic bone screw, non-bioabsorbable, non-sterile
Small Hyperlordotic 3DP ALIF 20mm x 24 degree
Genesys Orthopedics Systems LLC
1
In Commercial Distribution

  • M719GHA3D2024S0 ()

  • Height: 20 Millimeter
  • Angle: 24 degree
GHA3D-2024S

  • Metallic spinal fusion cage, non-sterile
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