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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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PICC 4F Single Lumen Catheter S Kit
Biowy Corporation
PICC4SK-S
In Commercial Distribution

  • 00851739007156 ()
  • 00851739007194 ()
  • 00851739007200 ()


  • Peripherally-inserted central venous catheter
Atlas SSLR Buttress Assembly
STANDARD BARIATRICS, INC
IPN928199
In Commercial Distribution

  • 00851677007140 ()
  • 20851677007144 ()
SSLR23

  • Staple line-reinforcement strip
EnVisio System including the following components: SmartSurface, foot pedal and heads-up display
Elucent Medical, Inc.
ENVISIO-SYS
In Commercial Distribution

  • 00851674008553 ()


  • Radiological image marker, implantable
EnVisio System SmartSensor & SmartCal Calibration Disk
Elucent Medical, Inc.
SMARTSENSOR
In Commercial Distribution

  • 00851674008454 ()
  • 10851674008451 ()


  • Radiological image marker, implantable
Screenless version of the Envisio Navigator and SmartCal Calibration Disk
Elucent Medical, Inc.
NAV-SLIM
Not in Commercial Distribution

  • 00851674008348 ()
NAV-SLIM

  • Radiological image marker, implantable
Envisio Navigation Patient Pad - RF Sponge Detection Compatible
Elucent Medical, Inc.
ENVISIO-PP1
Not in Commercial Distribution

  • 00851674008232 ()
ENVISIO-PP2

  • Radiological image marker, implantable
EnVisio Navigation System Heads Up Display
Elucent Medical, Inc.
ENVISIO-HUD2
Not in Commercial Distribution

  • 00851674008225 ()
ENVISIO-HUD2

  • Radiological image marker, implantable
Screenless version of the Envisio Navigator and Calibration Disk
Elucent Medical, Inc.
NAV-SLIM
Not in Commercial Distribution

  • 00851674008072 ()
NAV-SLIM

  • Radiological image marker, implantable
EnVisio Navigation System Heads Up Display
Elucent Medical, Inc.
ENVISIO-HUD1
Not in Commercial Distribution

  • 00851674008065 ()
ENVISIO-HUD1

  • Radiological image marker, implantable
Envisio Navigation Patient Pad
Elucent Medical, Inc.
ENVISIO-PP1
Not in Commercial Distribution

  • 00851674008058 ()
ENVISIO-PP1

  • Radiological image marker, implantable
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