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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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hemostatic dressing
Chitogen Inc
2010
In Commercial Distribution

  • 10862499000254 ()
  • 00862499000257 ()

  • Length: 1 Inch
  • Width: 1 Inch


  • Wound-nonadherent dressing, permeable, non-antimicrobial
Topical hemostatic pad
Chitogen Inc
2150
In Commercial Distribution

  • 00862499000202 ()
  • 10862499000209 ()

  • Length: 2 Inch
  • Width: 2 Inch


  • Wound-nonadherent dressing, permeable, non-antimicrobial
The TherOx DownStream System, is indicated for the preparation and delivery of SuperSaturated Oxygen Therapy (SSO2 Therapy) to targeted ischemic regions perfused by the patient’s left anterior descending coronary artery immediately following revascularization by means of percutaneous coronary intervention (PCI) with stenting that has been completed within 6 hours after the onset of anterior acute myocardial infarction (AMI) symptoms caused by a left anterior descending artery infarct lesion.
THEROX, INC.
SSO2 - 5.0
In Commercial Distribution

  • 20862478000463 ()
  • 00862478000469 ()
  • 10862478000466 ()

  • 5F


  • Supersaturated oxygen therapy system catheter
The TherOx DownStream System, is indicated for the preparation and delivery of SuperSaturated Oxygen Therapy (SSO2 Therapy) to targeted ischemic regions perfused by the patient’s left anterior descending coronary artery immediately following revascularization by means of percutaneous coronary intervention (PCI) with stenting that has been completed within 6 hours after the onset of anterior acute myocardial infarction (AMI) symptoms caused by a left anterior descending artery infarct lesion.
THEROX, INC.
SSO2 - 4.5
In Commercial Distribution

  • 20862478000456 ()
  • 00862478000452 ()
  • 10862478000459 ()

  • 5F


  • Supersaturated oxygen therapy system catheter
The TherOx DownStream System, is indicated for the preparation and delivery of SuperSaturated Oxygen Therapy (SSO2 Therapy) to targeted ischemic regions perfused by the patient’s left anterior descending coronary artery immediately following revascularization by means of percutaneous coronary intervention (PCI) with stenting that has been completed within 6 hours after the onset of anterior acute myocardial infarction (AMI) symptoms caused by a left anterior descending artery infarct lesion.
THEROX, INC.
SSO2 - 3.5
In Commercial Distribution

  • 20862478000449 ()
  • 00862478000445 ()
  • 10862478000442 ()

  • 5F


  • Supersaturated oxygen therapy system catheter
The TherOx DownStream System, is indicated for the preparation and delivery of SuperSaturated Oxygen Therapy (SSO2 Therapy) to targeted ischemic regions perfused by the patient’s left anterior descending coronary artery immediately following revascularization by means of percutaneous coronary intervention (PCI) with stenting that has been completed within 6 hours after the onset of anterior acute myocardial infarction (AMI) symptoms caused by a left anterior descending artery infarct lesion.
THEROX, INC.
SSO2 - 4.0
In Commercial Distribution

  • 20862478000432 ()
  • 00862478000438 ()
  • 10862478000435 ()

  • 5F


  • Supersaturated oxygen therapy system catheter
The TherOx DownStream System, is indicated for the preparation and delivery of SuperSaturated Oxygen Therapy (SSO2 Therapy) to targeted ischemic regions perfused by the patient’s left anterior descending coronary artery immediately following revascularization by means of percutaneous coronary intervention (PCI) with stenting that has been completed within 6 hours after the onset of anterior acute myocardial infarction (AMI) symptoms caused by a left anterior descending artery infarct lesion.
THEROX, INC.
DSC-2
In Commercial Distribution

  • 10862478000428 ()
  • 00862478000421 ()


  • Supersaturated oxygen therapy system cartridge
Peregrine System™ Infusion Catheter (3-4 mm), 510k, US
ABLATIVE SOLUTIONS, INC.
FG32112
In Commercial Distribution

  • 00862468000356 ()

  • Length: 86 Centimeter
  • 3-4mm
  • Outer Diameter: 0.077 Inch


  • Peripheral vascular intervention infusion catheter
Peregrine System™ Infusion Catheter (4-7 mm), 510k, US
ABLATIVE SOLUTIONS, INC.
FG32111
In Commercial Distribution

  • 00862468000349 ()

  • Length: 86 Centimeter
  • 4-7mm
  • Outer Diameter: .077 Inch


  • Peripheral vascular intervention infusion catheter
Peregrine System Infusion Catheter, US
ABLATIVE SOLUTIONS, INC.
FG32101
Not in Commercial Distribution

  • 00862468000318 ()

  • Length: 86 Centimeter
  • 5-7mm
  • Outer Diameter: 0.078 Inch


  • Peripheral vascular intervention infusion catheter
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