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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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ACTEGY LIMITED
1570
In Commercial Distribution

  • 00858058005030 ()
  • 10858058005020 ()
  • 00858058005023 ()
1570

  • Transcutaneous electrical stimulation electrode, single-use
The Neuroprobe® 500 Pro gives the clinician the option of using any combination of an Estim probe, Interferential Current in bipolar or quadripolar modes, or Monochromatic Infrared Therapy to reduce pain and increase circulation. Flexible neoprene pads deliver heat and Infrared therapy through multiple clusters of infrared and red visible super luminous diodes (SLD). The Neuroprobe® 500 Pro’s optional probe with fully adjustable parameters provides a wide variety of uses for pain management with trigger point stimulation for pain control. The Neuroprobe® 500 Pro provides a nerve block mode through treatment pads with high output capable of sensory nerve block, or through the optional probe to produce local trigger point anesthesia.
ACCELERATED CARE PLUS CORP
140500B
In Commercial Distribution

  • 00858703006054 ()
  • 10858703006051 ()


  • Multi-modality physical therapy system, professional-use
Box of 10 Velcro Pads
NIMBIC SYSTEMS, INC.
Model 4001
Not in Commercial Distribution

  • 00869284000225 ()
ABS-4001

  • High-efficiency filter air cleaner, mobile
The InkSpace Imaging Body Array is a phased array, receive-only coil intended to work with GE 3.0T MRI scanners to provide optimal signal-to-noise ratio and uniformity for high resolution body MR imaging examinations. The size and layout of individual channels of the InkSpace Imaging Body Array were designed specifically to fit body imaging. The coil is comprised of 24 total channels, with two individual flexible pads, intended to be placed anterior and posterior to the patient, containing 12 individual elements. The elements are optimized to be flexible to conform to a pediatric patient’s anatomy.
Inkspace Imaging, Inc.
PBA24GE30B
In Commercial Distribution

  • 00860008041340 ()


  • MRI system coil, radio-frequency
The InkSpace Imaging Pediatric Body Array is a phased array, receive-only coil intended to work with GE 3.0T MRI scanners to provide optimal signal-to-noise ratio and uniformity for high resolution pediatric body MR imaging examinations. The size and layout of individual channels of the InkSpace Imaging Pediatric Body Array were designed specifically to fit the pediatric population for body imaging. The coil is comprised of 24 total channels, with two individual flexible pads, intended to be placed anterior and posterior to the patient, containing 12 individual elements. The elements are optimized to be flexible to conform to a pediatric patient’s anatomy.
Inkspace Imaging, Inc.
PBA24GE30A
In Commercial Distribution

  • 00860008041326 ()


  • MRI system coil, radio-frequency
The InkSpace Imaging Nuzzle Veterinary Array is a phased array, receive-only coil designed to work on Siemens 3.0 Tesla (3.0T) MRI scanners. It consists of 24 elements which are optimized to be lightweight and flexible to easily conform to a patient’s anatomy, providing high signal-to-noise ratio. It includes two identical pads, which each contain 12 elements. The two pads can be positioned separately, such that setup time is minimized.
Inkspace Imaging, Inc.
SBA24SH30D
In Commercial Distribution

  • 00860008041357 ()


  • MRI system coil, radio-frequency
The InkSpace Imaging Snuggle Pediatric Array is a phased array, receive-only coil designed to work on GE 3.0 Tesla (3.0T) MRI scanners. It consists of 24 elements which are optimized to be lightweight and flexible to easily conform to a patient’s anatomy, providing high signal-to-noise ratio. It includes two identical pads, which each contain 12 elements. The two pads can be positioned separately, such that setup time is minimized. The space dinosaur theme is child friendly and designed to help reduce anxiety during the MR scan.
Inkspace Imaging, Inc.
SBA24GE30A
In Commercial Distribution

  • 00860008041333 ()


  • MRI system coil, radio-frequency
The InkSpace Imaging Silhouette Adult Array is a phased array, receive-only coil designed to work on Siemens 3.0 Tesla (3.0T) MRI scanners. It consists of 24 elements which are optimized to be lightweight and flexible to easily conform to a patient’s anatomy, providing high signal-to-noise ratio. It includes two identical pads, which each contain 12 elements. The two pads can be positioned separately, such that setup time is minimized.
Inkspace Imaging, Inc.
SBA24SH30C
In Commercial Distribution

  • 00860008041319 ()


  • MRI system coil, radio-frequency
The InkSpace Imaging Snuggle Pediatric Array is a phased array, receive-only coil designed to work on Siemens 3.0 Tesla (3.0T) MRI scanners. It consists of 24 elements which are optimized to be lightweight and flexible to easily conform to a patient’s anatomy, providing high signal-to-noise ratio. It includes two identical pads, which each contain 12 elements. The two pads can be positioned separately, such that setup time is minimized. The space dinosaur theme is child friendly and designed to help reduce anxiety during the MR scan.
Inkspace Imaging, Inc.
SBA24SH30B
In Commercial Distribution

  • 00860008041302 ()


  • MRI system coil, radio-frequency
Needle, Vacutainer® Safety-Lok™ Blood Collection Set
CAREDX, INC.
RMT-00011
In Commercial Distribution

  • 00860193001754 ()
RMT-00011

  • Phlebotomy kit
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