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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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Sage 12c - 00815871021425

No Description
Avante
60130H
In Commercial Distribution

  • 00815871021425 ()


  • Electrocardiographic ambulatory recorder

CardioSTAT - 27540279250142

CardioSTAT Installation Kit - ECG Recorder 14D Test
Icentia Inc.
10-006
In Commercial Distribution

  • 27540279250142 ()


  • Electrocardiographic ambulatory recorder

CardioSTAT - 27540279250074

CardioSTAT Installation Kit - ECG Recorder 7D Test
Icentia Inc.
10-006
In Commercial Distribution

  • 27540279250074 ()


  • Electrocardiographic ambulatory recorder

CardioSTAT - 27540279250029

CardioSTAT Installation Kit - ECG Recorder 2D Test.
Icentia Inc.
10-006
In Commercial Distribution

  • 27540279250029 ()


  • Electrocardiographic ambulatory recorder

Stealth System S300 - 20857553006072

Stealth System Wearable Sensor (M300).
CARDIAC INSIGHT, INC.
M300-5
Not in Commercial Distribution

  • 20857553006072 ()
  • 00857553006078 ()
M300-5

  • Electrocardiographic ambulatory recorder

Sureform - 00886874121726

8mm Stapler
INTUITIVE SURGICAL, INC.
488530
In Commercial Distribution

  • 10886874121723 ()
  • 00886874121726 ()

  • Outer Diameter: 8 Millimeter
  • Length: 30 Millimeter


  • Robotic surgical cutting stapler, reusable

CardioSTAT - 17540279200140

CardioSTAT ECG Recorder 14D test.
Icentia Inc.
10-006
In Commercial Distribution

  • 17540279200140 ()
  • 27540279200147 ()


  • Electrocardiographic ambulatory recorder

CardioSTAT - 17540279200072

CardioSTAT ECG Recorder 7D Test.
Icentia Inc.
10-006
In Commercial Distribution

  • 17540279200072 ()
  • 27540279200079 ()


  • Electrocardiographic ambulatory recorder

EART - 17540279105018

ECG Analysis and Reporting Tool.
Icentia Inc.
10-501
In Commercial Distribution

  • 17540279105018 ()


  • Electrocardiographic long-term ambulatory recording analyser application software

SureForm - 00886874123652

45mm Curved Tip Stapler
INTUITIVE SURGICAL, INC.
436504
In Commercial Distribution

  • 10886874123659 ()
  • 00886874123652 ()

  • Length: 45 Millimeter
  • Outer Diameter: 14 Millimeter


  • Robotic surgical cutting stapler, single-use
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