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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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
DynaRide Reclining Wheelchair with Elevating Leg Rest 24"
Dynarex Corporation
10249
In Commercial Distribution

  • 00616784024912 ()


  • Wheelchair, attendant/occupant-driven, rear-wheels-operated, collapsible
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
Medium Hyperlordotic 3DP ALIF 20mm x 24 degree
Genesys Orthopedics Systems LLC
1
In Commercial Distribution

  • M719GHA3D2024M0 ()

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

  • Metallic spinal fusion cage, non-sterile
Large Hyperlordotic 3DP ALIF 20mm x 24 degree
Genesys Orthopedics Systems LLC
1
In Commercial Distribution

  • M719GHA3D2024L0 ()

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

  • Metallic spinal fusion cage, non-sterile
Small Hyperlordotic 3DP ALIF 18mm x 24 degree
Genesys Orthopedics Systems LLC
1
In Commercial Distribution

  • M719GHA3D1824S0 ()

  • Height: 18 Millimeter
  • Angle: 24 degree
GHA3D-1824S

  • Metallic spinal fusion cage, non-sterile
Medium Hyperlordotic 3DP ALIF 18mm x 24 degree
Genesys Orthopedics Systems LLC
1
In Commercial Distribution

  • M719GHA3D1824M0 ()

  • Height: 18 Millimeter
  • Angle: 24 degree
GHA3D-1824M

  • Metallic spinal fusion cage, non-sterile
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