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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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Merit Medical Systems, Inc.
A
In Commercial Distribution

  • 10884450008772 ()
  • 00884450008775 ()

  • Introducer French Size (F)-5F
  • Needle Gauge (G)-21G
  • Introducer Length (cm)-10 cm (4")
  • Guide Wire Diameter (OD)-0.018" (0.46 mm)
MAK505-PED

  • Vascular dilator, single-use
The QT Scanner 2000 Model A is an automated and software-controlled ultrasound system for breast imaging that can be operated by a single operator. The system consists of an examination table, a scan tank, image processing electronics, operator console, breast retention device, and ultrasound beam forming electronics. The QT Scanner 2000 Model A is for use as an ultrasonic imaging system to provide reflection mode and transmission mode images of a patient’s breast.
Qt Imaging, Inc.
A
In Commercial Distribution

  • 00852619008003 ()
100366

  • General-purpose ultrasound imaging system
pNeuton Ventilator, model A
AIRON CORPORATION
A
In Commercial Distribution

  • 00853678006009 ()

  • Depth: 7.3 Inch
  • Width: 10.0 Inch
  • Height: 5.0 Inch
  • Weight: 6.5 Pound
20052

  • Portable pneumatic ventilator
prolaio Convenience Kit - Model A
Prolaio, Inc.
A
In Commercial Distribution

  • 00850071330106 ()


  • Electrocardiography monitoring system receiver
Tangible Clean is a multipurpose contact lens cleaner designed for use with gas permeable contact lenses, and is compatible for use with Tangible Hydra-PEG.
TANGIBLE SCIENCE, LLC
A
In Commercial Distribution

  • 00198168983577 ()
FG0823

  • Multi-purpose soft/rigid contact lens solution
  • Multi-purpose rigid contact lens solution
A 3oz sample bottle of Tangible Clean, a multipurpose cleaner for gas permeable contact lenses and approved for use with Tangible Hydra-PEG.
TANGIBLE SCIENCE, LLC
A
In Commercial Distribution

  • 00198168596739 ()
FG0860

  • Multi-purpose rigid contact lens solution
  • Multi-purpose soft/rigid contact lens solution
The APAS Independence is intended to be used by a microbiology laboratory to read, interpret and sort culture plates in order to screen for the presence of microbial growth relevant for specific clinical conditions (e.g. urinary tract infection). The instrument may host multiple Analysis Modules, each of which is used to screen for a specific purpose. See https://cleverculturesystems.com for further information.
Clever Culture Systems AG
A
In Commercial Distribution

  • 09354646000001 ()
AI-16001

  • Microbial culture plate imaging/analysis system IVD
Unit;2.5m, ECG cable for Task Force® Monitor without protection against defibrillation, "double nose" connector
CNSystems Medizintechnik GmbH
A
In Commercial Distribution

  • 09120073932112 ()
00021

  • General-purpose multi-parameter bedside monitor
Unit;2.5m, ICG cable for Task Force® Monitor without protection against defibrillation, "double nose" connector
CNSystems Medizintechnik GmbH
A
In Commercial Distribution

  • 09120073932105 ()
00031

  • General-purpose multi-parameter bedside monitor
Unit;2.5m, ICG cable for Task Force® Monitor with protection against defibrillation, "double nose" connector
CNSystems Medizintechnik GmbH
A
In Commercial Distribution

  • 09120073931900 ()
00033

  • General-purpose multi-parameter bedside monitor
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