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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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Vista Solution® 30-day Monitoring Kit
Vital Connect, Inc.
9430-01
In Commercial Distribution

  • 00850490007252 ()
9430-01

  • Electrocardiography telemetric monitoring system
VitalPatch 2.0, 7 days
Vital Connect, Inc.
3037-01
In Commercial Distribution

  • 00850490007245 ()
  • 00850490007238 ()
3037-01

  • Electrocardiography telemetric monitoring system
VitalPatch 2.0 Single
Vital Connect, Inc.
3035-01
In Commercial Distribution

  • 00850490007214 ()
  • 00850490007221 ()
3035-01

  • Electrocardiography telemetric monitoring system
Foley Catheter Securement device for 10-14 Fr.
STARBOARD MEDICAL, INC.
FCS-1074
In Commercial Distribution

  • 10850933007280 ()
  • 00850933007283 ()
FCS-1074

  • Urinary catheter holder, sterile
No Description
FAXITRON BIOPTICS, LLC
PathVision 23x29
In Commercial Distribution

  • 00857069006289 ()


  • Stationary specimen x-ray system, digital
No Description
FAXITRON BIOPTICS, LLC
CoreVision 5x10
In Commercial Distribution

  • 00857069006272 ()


  • Stationary specimen x-ray system, digital
Stationary Cabinet x-ray system with 15x15 cm imager used to provide two and three dimensional digital x-ray images of harvested specimens from various anatomical regions.
FAXITRON BIOPTICS, LLC
VisionCT 15x15
In Commercial Distribution

  • 00857069006227 ()


  • Stationary specimen x-ray system, digital
Whole Blood Aggregometer
AGGREDYNE, INC.
A-100
In Commercial Distribution

  • 00856893004041 ()
  • 00856893004065 ()
  • 00856893004003 ()


  • Platelet aggregation analyser IVD, automated
IV START KIT
MEDLINE INDUSTRIES, INC.
DYNDV2102A
In Commercial Distribution

  • 40889942881872 ()
  • 10889942881871 ()
DYNDV2102A

  • Peripheral intravenous catheterization support kit
Benesta Single-Use Seals for Benesta Rod Lens Hysteroscope
Caldera Medical, Inc.
CAL-1421
In Commercial Distribution

  • 00857492008072 ()
  • 00857492008126 ()


  • Endoscope working-channel seal
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