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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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Benesta Single-Use Seals for Benesta Rod Lens Hysteroscope
Caldera Medical, Inc.
CAL-1421
In Commercial Distribution

  • 00857492008072 ()
  • 00857492008126 ()


  • Endoscope working-channel seal
Lease Handheld electronic device which receives temperature sensitive crystal oscillations via near field magnetic link. The oscillation measurement is converted to a temperature using the sensor's calibration number.
H Q, INC
HT150001L
In Commercial Distribution

  • 00857414006049 ()


  • Temperature telemetric monitoring system transmitter
Plastic adapter that allows for a luer lock drain line to connect to a press fit catheter
JIGSAW MEDICAL, LLC
A21418
In Commercial Distribution

  • 00856274008002 ()
  • 00856274008033 ()
A21418

  • General-purpose catheter connector, sterile
No Description
IHEALTH LAB INC.
ECG3
In Commercial Distribution

  • 10856362005019 ()
  • 00856362005012 ()


  • Electrocardiography telemetric monitoring system
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
CBCII Constavac Blood Conservation System (No Drain)
3T MEDICAL SYSTEMS, INC.
225-028-000E
In Commercial Distribution

  • 00855168008388 ()
  • 00855168008371 ()
225-028-000E

  • Whole-blood-recovery autotransfusion system, powered
ConstaVac CBCII with Quick Disconnect, 3/16” Round PVC Drain & Trocar
3T MEDICAL SYSTEMS, INC.
225-028-926
In Commercial Distribution

  • 00855168008302 ()
  • 00855168008296 ()

  • 4.8 Millimeter
225-028-926

  • Whole-blood-recovery autotransfusion system, powered
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