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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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ULTROMICS LIMITED
Heart Failure 2.0
In Commercial Distribution

  • 05060634690058 ()


  • Radiology DICOM image processing application software
  • Cardiac mapping system application software
  • Ultrasound imaging system application software
No Description
ULTROMICS LIMITED
Heart Failure 1.0
In Commercial Distribution

  • 05060634690041 ()


  • Radiology DICOM image processing application software
  • Cardiac mapping system application software
  • Ultrasound imaging system application software
No Description
ULTROMICS LIMITED
Core 2.0
In Commercial Distribution

  • 05060634690027 ()


  • Radiology DICOM image processing application software
  • Cardiac mapping system application software
  • Ultrasound imaging system application software
No Description
ULTROMICS LIMITED
Core
In Commercial Distribution

  • 05060634690003 ()


  • Radiology DICOM image processing application software
  • Cardiac mapping system application software
  • Ultrasound imaging system application software
The Illumina MiSeqDx is a sequencing instrument that measures fluorescence signals of labeled nucleotides through the use of instrument specific reagents and flow cells (MiSeqDx Universal Kit 1.0), imaging hardware, and data analysis software.
ILLUMINA, INC.
15036706
In Commercial Distribution

  • 00816270020002 ()
DX-410-1001

  • Nucleic acid sequence analyser IVD, next-generation sequencing (NGS)
Extended Mounting Pins (4pcs). Hardware for Matrx Elite, E2 Backs (18H/20H) and PB Backs. Extended pins allow mounting onto back canes up to 2" wider than nominal back width (up to 20" back widths).
Motion Concepts Inc
EMP
In Commercial Distribution

  • 07540147000622 ()
EMP

  • Wheelchair back rest positioner pin
One-Piece Flat Calf Panel Mount Assy designed for use with Motion Concepts CM Legrests (includes mounting hardware). One-Piece Calf Pad sold separately. Available in a variety of widths and heights to accommodate different user needs.
Motion Concepts Inc
D-0101-0157-OSCPL
In Commercial Distribution

  • 07540147002473 ()
OSCPL

  • Wheelchair footrest/legrest
  • Wheelchair legrest pad
Flat Hand Pad. (Molded, skinned polyurethane hand pad designed for use in combination with the Ergonomic Arm Trough (sold separately)). The Flat Hand Pad is compatible with Left or Right Arm Troughs. Mounting hardware is included.
Motion Concepts Inc
D-0153-FHP
In Commercial Distribution

  • 07540147002718 ()
FHP

  • Wheelchair armrest
Fixed Joystick Mount Assembly. Components/hardware used to fix-mount a wheelchair joystick to the armrest on a Motion Concepts Power Positioning System. Straight or jogged tube option available. Can be mounted onto Left or Right armrests.
Motion Concepts Inc
D-0181-FJ
In Commercial Distribution

  • 07540147001971 ()
FJ

  • Wheelchair bracket/mount
Morpheus® Control Module
PROMETHEUS GROUP OF NEW HAMPSHIRE LIMITED, THE
MOR0118
In Commercial Distribution

  • 00852423006004 ()
MOR0118

  • Ultrasound imaging system operator console
  • Radiology DICOM image processing application software
  • Urodynamic measurement system
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