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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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250 mL EVA Bags, 2 Port
STRADIS MEDICAL, LLC
HCT20250
Not in Commercial Distribution

  • M752HCT202505 ()
  • M752HCT202501 ()


  • Intravenous administration bag/bottle
CVP Dressing Change Kit
STRADIS MEDICAL, LLC
HCT2020CP
Not in Commercial Distribution

  • M752HCT2020CP5 ()
  • M752HCT2020CP0 ()


  • Wound dressing kit, medicated
100mL EVA Bags, 2 Port
STRADIS MEDICAL LLC
HCT20100
In Commercial Distribution

  • M752HCT201006 ()
  • M752HCT201002 ()
  • M752HCT201000 ()


  • Intravenous administration bag/bottle
100 mL EVA Bags, 2 Port
STRADIS MEDICAL, LLC
HCT20100
Not in Commercial Distribution

  • M752HCT201005 ()
  • M752HCT201001 ()


  • Intravenous administration bag/bottle
DIALYSIS/CORDIS DRESSING CHANGE KIT BIOPATCH
STRADIS MEDICAL LLC
HCT200GD-BP
In Commercial Distribution

  • M752HCT200GDBP5 ()
  • M752HCT200GDBP0 ()


  • Wound dressing kit, medicated
DIALYSIS/CORDIS DRESSING CHANGE KIT-GUARDIVA
STRADIS MEDICAL LLC
HCT200GD-2
In Commercial Distribution

  • M752HCT200GD25 ()
  • M752HCT200GD20 ()


  • Arterial/central venous catheterization support/maintenance kit, non-medicated
Dressing Change Kit - Large Biopatch
STRADIS MEDICAL, LLC
HCT200BP
Not in Commercial Distribution

  • M752HCT200BP0 ()
  • M752HCT200BP5 ()


  • Arterial/central venous catheterization support/maintenance kit, non-medicated
Dressing Port Kit W/ Biopatch
STRADIS MEDICAL LLC
HCT1313B
In Commercial Distribution

  • M752HCT1313B5 ()
  • M752HCT1313B0 ()


  • Wound dressing kit, medicated
Dressing Change Tray W/ Biopatch
STRADIS MEDICAL LLC
HCT1212SB
In Commercial Distribution

  • M752HCT1212SB5 ()
  • M752HCT1212SB0 ()


  • Wound dressing kit, medicated
500mL EVA Bags, 2 Port
STRADIS MEDICAL LLC
HCT10500
In Commercial Distribution

  • M752HCT105006 ()
  • M752HCT105002 ()
  • M752HCT105000 ()


  • Intravenous administration bag/bottle
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