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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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A sterile container designed to be connected to an invasive drain/drainage catheter (not included) to collect fluids or purulent material being removed during drainage of a body cavity, a closed-wound, and/or the bile duct; it is not intended for drainage of cerebrospinal fluid (CSF) or blood. It is typically in the form of a bottle, bag, or bulb with fluid volume markers, and might include a hand-operated pump (e.g., suction bulb) and tubing; it does not include any invasive components or powered devices. This is a single-use device.
Innoventa Medica ApS
1070
In Commercial Distribution

  • 05700002169778 ()


  • Closed-wound/centesis drainage receptacle
A sterile container designed to be connected to an invasive drain/drainage catheter (not included) to collect fluids or purulent material being removed during drainage of a body cavity, a closed-wound, and/or the bile duct; it is not intended for drainage of cerebrospinal fluid (CSF) or blood. It is typically in the form of a bottle, bag, or bulb with fluid volume markers, and might include a hand-operated pump (e.g., suction bulb) and tubing; it does not include any invasive components or powered devices. This is a single-use device.
Innoventa Medica ApS
1061
In Commercial Distribution

  • 05700002169747 ()
  • 05700002169716 ()


  • Closed-wound/centesis drainage receptacle
A sterile container designed to be connected to an invasive drain/drainage catheter (not included) to collect fluids or purulent material being removed during drainage of a body cavity, a closed-wound, and/or the bile duct; it is not intended for drainage of cerebrospinal fluid (CSF) or blood. It is typically in the form of a bottle, bag, or bulb with fluid volume markers, and might include a hand-operated pump (e.g., suction bulb) and tubing; it does not include any invasive components or powered devices. This is a single-use device.
Innoventa Medica ApS
1060
In Commercial Distribution

  • 05700002169730 ()
  • 05700002169716 ()


  • Closed-wound/centesis drainage receptacle
The ECGenius™ System is an electrophysiology measurement system and analysis tool used to acquire, filter, digitize, amplify, display, record, and analyze data obtained during electrophysiological studies and related procedures. The system is compatible with a 3rd-party stimulator, intended to be used for diagnostic cardiac stimulation during electrophysiological testing of the heart. The PVI Analyzer™ feature is a secondary measure of pulmonary vein isolation and should not replace traditional methods of confirming isolation.
Cathvision ApS
CVT-0069 R3.0
Not in Commercial Distribution

  • 05700002168535 ()
CVT-0069 R3.0 ECGenius System

  • Cardiac electrophysiology analysis system
The ECGenius System is a computerized electrophysiology measurement system designed for both regular and experimental EP studies.The ECGenius System is an electrophysiology measurement system used to acquire, filter, digitize, amplify, display, and record clinical data obtained during electrophysiological studies and related procedures. The system is compatible with a 3rd-party stimulator, intended to be used for diagnostic cardiac stimulation during electrophysiological testing of the heart.
Cathvision ApS
CVT-0069 R2.0
Not in Commercial Distribution

  • 05700002168528 ()
CVT-0069 R2.0 ECGenius System

  • Cardiac electrophysiology analysis system
The Norlase LYNX photocoagulator is intended to be used in ophthalmic laser procedures including retinal and macular photocoagulation, iridotomy, and trabeculoplasty.
Norlase ApS
N008-9200
In Commercial Distribution

  • 05700002165466 ()


  • Ophthalmic diode laser system
  • Indirect binocular laser ophthalmoscope
The Norlase ECHO Photocoagulator is intended to be used in ophthalmic laser procedures including retinal and macular photocoagulation, iridotomy, and trabeculoplasty
Norlase ApS
N007-9200-Z
In Commercial Distribution

  • 05700002165459 ()


  • Ophthalmic diode laser system
The Norlase LEAF Photocoagulator is intended to be used in ophthalmic laser procedures including retinal and macular photocoagulation, iridotomy, and trabeculoplasty
Norlase ApS
N005-9010-Z
In Commercial Distribution

  • 05700002165442 ()


  • Ophthalmic diode laser system
The Norlase ECHO Photocoagulator is intended to be used in ophthalmic laser procedures including retinal and macular photocoagulation, iridotomy, and trabeculoplasty
Norlase ApS
N007-9200
In Commercial Distribution

  • 05700002165435 ()


  • Ophthalmic diode laser system
The Norlase LION Photocoagulator is intended to be used in ophthalmic laser procedures including retinal and macular photocoagulation, iridotomy, and trabeculoplasty
Norlase ApS
N006-9200
In Commercial Distribution

  • 05700002165428 ()


  • Indirect binocular laser ophthalmoscope
  • Ophthalmic diode laser system
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