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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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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.
DS-1
In Commercial Distribution

  • 00862478000414 ()


  • Supersaturated oxygen therapy system
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.
DS-1 (Refurbished)
In Commercial Distribution

  • 00862478000407 ()


  • Supersaturated oxygen therapy system
STERILE MINERVA Disposable Handpiece Contents: (1) One Single use STERILE Minerva ES Disposable Handpiece (1) One Single Use STERILE Syringe (1) One Single Use STERILE 8mm Hegar Dilator (1) One Single use NON-STERILE Desiccant (1) One NON-STERILE Handpiece Instructions For Use (1) One NON-STERILE Dilator Instructions For Use
Minerva Surgical, Inc.
MIN9770
In Commercial Distribution

  • 00862393000162 ()
  • 00862393000117 ()
MIN9770

  • Inert gas-enhanced endoscopic electrosurgical submucosal lift/resection instrument
Minerva Desiccant
Minerva Surgical, Inc.
MINDESI
In Commercial Distribution

  • 00862393000155 ()
MINDESI

  • Inert gas-enhanced endoscopic electrosurgical submucosal lift/resection instrument
Minerva Co2 Canister (5 Pack)
Minerva Surgical, Inc.
MINCo2C
In Commercial Distribution

  • 00862393000148 ()
  • 10862393000145 ()
MINCo2C

  • Inert gas-enhanced endoscopic electrosurgical submucosal lift/resection instrument
Minerva Argon Gas Canister (offered in 5 pack)
Minerva Surgical, Inc.
MINARGC
In Commercial Distribution

  • 00862393000131 ()
  • 10862393000138 ()
MINARGC

  • Inert gas-enhanced endoscopic electrosurgical submucosal lift/resection instrument
100 Joule ECT Device with 1 Parameter Setting Control
MECTA CORPORATION
4000DM
In Commercial Distribution

  • 00861539000134 ()


  • Electroconvulsive therapy system
100 Joule ECT Device with 4 Parameter Setting Controls
MECTA CORPORATION
4000DQ
In Commercial Distribution

  • 00861539000127 ()


  • Electroconvulsive therapy system
100 Joule ECT Device with 1 Parameter Setting Control and Patient Monitoring
MECTA CORPORATION
5000DM
In Commercial Distribution

  • 00861539000110 ()


  • Electroconvulsive therapy system
100 Joule ECT Device with 4 Parameter Setting Controls and Patient Monitoring
MECTA CORPORATION
5000DQ
In Commercial Distribution

  • 00861539000103 ()


  • Electroconvulsive therapy system
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