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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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FLEX Polyclonal Guinea Pig Anti-Insulin Ready-to-Use (Link)
AGILENT TECHNOLOGIES, INC.
IR002
In Commercial Distribution

  • 05700571101186 ()

  • 40-60 Tests


  • Insulin IVD, antibody
Artisan User Fillable Dispenser #1
AGILENT TECHNOLOGIES, INC.
AR185
Not in Commercial Distribution

  • 05700571101032 ()

  • 200 Tests


  • Assay container IVD, single-use
Artisan Alpha Amylase
AGILENT TECHNOLOGIES, INC.
AR171
Not in Commercial Distribution

  • 05700571100745 ()

  • 50 Tests


  • Biological stain IVD
Artisan Alpha Amylase
AGILENT TECHNOLOGIES, INC.
AR171
In Commercial Distribution

  • 05700571100738 ()

  • 100 Tests


  • Biological stain IVD
FLEX Monoclonal Mouse Anti-Human E-Cadherin Clone NCH-38 Ready-to-Use (Dako Autostainer/ Autostainer Plus)
AGILENT TECHNOLOGIES, INC.
IS059
Not in Commercial Distribution

  • 05700571011539 ()

  • 20-30 Tests


  • Cadherin protein IVD, antibody
CADScor System (ACS-1401), 1x system package. US-FDA version. The intended use of the CADScor System is to record heart sounds, murmurs and vibration for calculation of a patient specific score, indicating the risk of coronary stenosis, as an aid in cardiac analysis and diagnosis.
Acarix A/S
ACS-1401
In Commercial Distribution

  • 05700002223050 ()
  • 05700002223067 ()
ACS-1401 (1x, US-FDA)

  • Phonocardiograph
Acarix CADScor Patch, 20x patch in box. The intended use of the CADScor System is to record heart sounds, murmurs and vibration for calculation of a patient specific score, indicating the risk of coronary stenosis, as an aid in cardiac analysis and diagnosis.
Acarix A/S
ACP-1401
In Commercial Distribution

  • 05700002223012 ()
  • 05700002223029 ()
  • 05700002223036 ()
ACP-1401 (20x)

  • Phonocardiograph
No Description
Radiobotics ApS
v.1.
In Commercial Distribution

  • 05700002173614 ()


  • X-ray image interpretive software
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
1071
In Commercial Distribution

  • 05700002169785 ()


  • 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
1070
In Commercial Distribution

  • 05700002169778 ()


  • Closed-wound/centesis drainage receptacle
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