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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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No Description
Merit Medical Systems, Inc.
A
In Commercial Distribution

  • 10884450295530 ()
  • 00884450295533 ()

  • French Size (F)-15F
  • Catheter Length Tip-Cuff (cm)-19 cm
CENFT19C

  • Double-lumen haemodialysis catheter, implantable
No Description
Merit Medical Systems, Inc.
A
In Commercial Distribution

  • 10884450021344 ()
  • 00884450021347 ()
  • 20884450021341 ()
IN9802

  • Catheter/overtube balloon inflator, single-use
No Description
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
931
Eca Medical Instruments
A
In Commercial Distribution

  • 00857676008324 ()
991067S

  • Orthopaedic surgical procedure kit, non-medicated, single-use
930
Eca Medical Instruments
A
In Commercial Distribution

  • 00857676008263 ()
991066S

  • Orthopaedic surgical procedure kit, non-medicated, single-use
prolaio Convenience Kit - Model A
Prolaio, Inc.
A
In Commercial Distribution

  • 00850071330106 ()


  • Electrocardiography monitoring system receiver
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
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
Cabinet system that includes Emission Computed Tomography (PET) with or without x-ray (e.g., CT) imaging including the software/hardware necessary to reconstruct the image and display to the end user
Xeos Medical
A
In Commercial Distribution

  • 15430002734023 ()
  • 05430002734026 ()


  • Instrument/analyser specimen/reagent container carrier IVD
Passive adapter with touchproof inputs and a high density output for adapting 3rd party electrode interface cables to the ATLAS Neurophysiology System. Version "A" is labeled for connections to electrodes 1-64.
NEURALYNX, INC.
-A
In Commercial Distribution

  • 00850011306369 ()
31-0602-0032

  • Electrical-only medical device connection cable, reusable
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