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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Cassette Printer with AutoLoader
SAKURA FINETEK U.S.A., INC.
9020
In Commercial Distribution

  • 00615233082374 ()
9020

  • Cell morphology analyser IVD, automated/semi-automated
  • Computed radiography digital imaging scanner
The OmnifyXR is an adjunctive augmented reality display to interventional x-ray imaging systems. The system is comprised of a commercial off-the-shelf augmented reality display, wirelessly connected to a server that interfaces with the imaging system. It is intended to simultaneously display up to four video streams and a 3D surface model holographically using an augmented reality headset, and provides functions for display of the video streams, display of the 3D surface, and remote collaboration. The system allows for the management and selection of the video streams displayed and allows for adjusting position and orientation of the 3D surface model in the augmented reality display. The OmnifyXR system is capable of telemedicine collaboration, allowing verbal and visual collaboration with a remote healthcare professional by sharing the augmented reality display and audio. The device is intended to be used as a collaborative integration system. It is an open platform that combines input from key devices in the interventional suite and provides this data to the user in a simplified and efficient manner. It is intended for use by trained proceduralists in clinical intervention and for applications where imaging is currently used.
Mediview Xr, Inc.
OXR-SYS
In Commercial Distribution

  • 00850044606061 ()


  • Medical image management system
  • Multidisciplinary medical image management software
PATRAN® dispensers, holds one box of any style PATRAN® slide sheets, 11”W x 9.5”L x 4”D, mounting hardware included. Made of PET.
Jamar Health Products, Inc.
9622 Dispenser
In Commercial Distribution

  • 00850050415176 ()
  • 00850050415169 ()


  • Patient transfer sliding mat
The Alinity c ACE Assay File is an accessory intended to be used for driving and influencing the use of the Alinity c system automated analyser hardware.
SENTINEL CH. SPA
06U86-1A
In Commercial Distribution

  • 08058056685445 ()
06U86-1A

  • Laboratory instrument/analyser application software IVD
The ARCHITECT c ACE Assay File is an accessory intended to be used for driving and influencing the use of the ARCHITECT c systems automated analyser hardware.
SENTINEL CH. SPA
6U82-1A
In Commercial Distribution

  • 08058056685438 ()
6U82-1A

  • Laboratory instrument/analyser application software IVD
Wheelchair Replacement Front Caster Assembly Includes Pneumatic Casters Fork Assembly And All Hardware Fits All MediChoice 18-20 Inch Wheelchairs Not Nat Rubber Ltx Non Sterile Reusable MediChoice
OWENS & MINOR DISTRIBUTION, INC.
GEY2CA
In Commercial Distribution

  • 20885632142540 ()
  • 10885632142543 ()


  • Wheelchair wheel
Applications Platform 4.0 INTL – INT KIT – 3 Room
IMRIS Imaging, Inc.
120088-000
In Commercial Distribution

  • 00857534006684 ()


  • Operating room audiovisual data/device management system application software
  • Operating room audiovisual data/device management system
Applications Platform 4.0 INTL – INT KIT
IMRIS Imaging, Inc.
120086-000
In Commercial Distribution

  • 00857534006677 ()


  • Operating room audiovisual data/device management system application software
  • Operating room audiovisual data/device management system
Applications Platform 4.0 INTL – 3 Room
IMRIS Imaging, Inc.
119898-000
In Commercial Distribution

  • 00857534006660 ()


  • Operating room audiovisual data/device management system application software
  • Operating room audiovisual data/device management system
Applications Platform 4.0-INTL-2-Room
IMRIS Imaging, Inc.
119408-000
In Commercial Distribution

  • 00857534006653 ()


  • Operating room audiovisual data/device management system application software
  • Operating room audiovisual data/device management system
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