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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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ViraTrans™, Viral Transport Media
CLARK LABORATORIES, INC.
B1029-35D
In Commercial Distribution

  • 05391516747264 ()

  • 50 x 2ml
B1029-35D

  • Viral transport medium IVD
IV START KIT
MEDLINE INDUSTRIES, INC.
DYNDV2101
In Commercial Distribution

  • 40889942590323 ()
  • 10889942590322 ()
DYNDV2101

  • Peripheral intravenous catheterization support kit
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
TRUMATCH Midface/Mandible - Titanium 3D Printed Orbital kit
Materialise NV
SD980.110
In Commercial Distribution

  • 05420060381102 ()


  • Craniofacial fixation plate kit, non-bioabsorbable
No Description
ROI CPS, LLC
UR00858B
In Commercial Distribution

  • 20194717102301 ()
  • 10194717102304 ()


  • Bladder irrigation kit
No Description
ROI CPS, LLC
UR00854
Not in Commercial Distribution

  • 20194717102288 ()
  • 10194717102281 ()


  • Bladder irrigation kit
IV Start Kit
MEDLINE INDUSTRIES, INC.
DYNDV1643
In Commercial Distribution

  • 40889942546054 ()
  • 10889942546053 ()
DYNDV1643

  • Peripheral intravenous catheterization support kit
WING 90-SRK-300210 ANGEL
MEDTRONIC, INC.
90-SRK-300210
In Commercial Distribution

  • 00643169774124 ()


  • Orthopaedic implant aiming/guiding block, reusable
Software which displays a patient's vital signs as part of the HTS820 patient-monitoring system.
LIFE SENSING INSTRUMENTS, INC.
TrensCenter VSP 1.100
In Commercial Distribution

  • 00857769008033 ()


  • Electrocardiography telemetric monitoring system
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