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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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HYPERStack-36, Silicone, Filte
Corning Incorporated
11778
In Commercial Distribution

  • H108117783 ()
  • H108117781 ()
11778

  • Blood/tissue storage/culture container
Corning HYPERStack, 36-Layer, CellBIND treated surface, wye and filter, Sterile, 1 per bag, 2 per case
Corning Incorporated
11776
In Commercial Distribution

  • H108117763 ()
  • H108117761 ()
11776

  • Blood/tissue storage/culture container
Corning HYPERStack, 12-Layer, CellBIND treated surface, wye and filter, Sterile, 1 per bag, 4 per case
Corning Incorporated
11775
In Commercial Distribution

  • H108117753 ()
  • H108117751 ()
11775

  • Blood/tissue storage/culture container
Sharps: 23 Qt. Btl Red
MEDEGEN MEDICAL PRODUCTS, LLC
187
In Commercial Distribution

  • H3621872 ()
  • HY3621870 ()
187

  • Sharps container
The NOVA is a Electrosurgical Pencil that has 3 LED battery powered located at the distal end for better visualization of the surgical field. The NOVA can be fitted with a smoke shroud that will remove the smoke plume from the site.The device is designed to work with all standard Electrosurgical Generators.
Pare Surgical, Inc
Hand Switching
In Commercial Distribution

  • HS101125 ()
  • HS112ESUPENCILS ()
900018

  • Open-surgery electrosurgical handpiece/electrode, monopolar, single-use
NAMIC Convenience Kit
NAVILYST MEDICAL, INC.
PKR61060911S
In Commercial Distribution

  • H965PKR61060911S1 ()
  • H965PKR61060911S0 ()


  • Angiography kit
Midline Convenience Kit
NAVILYST MEDICAL, INC.
PKMR61072273S
In Commercial Distribution

  • H965PKMR61072273S1 ()
  • H965PKMR61072273S0 ()

  • Single
  • Length: 20 Centimeter
  • Catheter Gauge: 4 French


  • Peripheral intravenous cannula
PICC Convenience Kit
NAVILYST MEDICAL, INC.
PKMR61072272S
In Commercial Distribution

  • H965PKMR61072272S1 ()
  • H965PKMR61072272S0 ()

  • Length: 55 Centimeter
  • Catheter Gauge: 5 French
  • Dual


  • Peripherally-inserted central venous catheter
Midline Convenience Kit
NAVILYST MEDICAL, INC.
PKMR61072271S
In Commercial Distribution

  • H965PKMR61072271S1 ()
  • H965PKMR61072271S0 ()

  • Catheter Gauge: 4 French
  • Length: 20 Centimeter


  • Peripheral intravenous cannula
Midline Convenience Kit
NAVILYST MEDICAL, INC.
PKMR61067725S
In Commercial Distribution

  • H965PKMR61067725S1 ()
  • H965PKMR61067725S0 ()

  • Length: 20 Centimeter
  • Catheter Gauge: 4 French


  • Peripheral intravenous cannula
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