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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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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
No Description
VIEWRAY INCORPORATED
A3i
In Commercial Distribution

  • 00850036816027 ()


  • Linear accelerator system
  • Stereotactic teletherapy radionuclide system, MRI-imaging
URETHROPLASTY GUIDE
GRACE MANUFACTURING, INC.
C0204-00
In Commercial Distribution

  • 10801334014001 ()

  • Catheter Gauge: 22 French


  • Suturing needle, reusable
Domed TIP CYSTOSCOPIC ELECTRODE, 4FR
GRACE MANUFACTURING, INC.
25823-05
In Commercial Distribution

  • 10801334009953 ()

  • Catheter Gauge: 4 French
CET107C

  • Open-surgery electrosurgical electrode, monopolar, reusable
SAFETY VEST
E.M. ADAMS, INC.
EP90612XLPB-1
Not in Commercial Distribution

  • 58100013411835 ()
  • 18100013411844 ()

  • X LARGE VEST/1.5" X 144" STRAP/1.5" X 21" STRAP


  • Limb/torso/head restraint, reusable
SAFETY VEST
E.M. ADAMS, INC.
EP90612SPB-1
Not in Commercial Distribution

  • 58100013411811 ()
  • 18100013411820 ()

  • SMALL VEST/1.5" X 144" STRAP/1.5" X 21" STRAP


  • Limb/torso/head restraint, reusable
SAFETY VEST
E.M. ADAMS, INC.
EP90612MPB-1
Not in Commercial Distribution

  • 58100013411798 ()
  • 18100013411806 ()

  • MEDIUM VEST/1.5" X 144" STRAP/1.5" X 21" STRAP


  • Limb/torso/head restraint, reusable
SAFETY VEST
E.M. ADAMS, INC.
EP90612M-1
Not in Commercial Distribution

  • 58100013411774 ()
  • 18100013411783 ()

  • MEDIUM VEST/1.5" X 144" STRAP


  • Limb/torso/head restraint, reusable
SAFETY VEST
E.M. ADAMS, INC.
EP90512L-1
Not in Commercial Distribution

  • 58100013411750 ()
  • 18100013411769 ()

  • LARGE VEST/1.5" X 144" STRAP


  • Limb/torso/head restraint, reusable
TORSO SUPPORT BELT
E.M. ADAMS, INC.
EP90580XXL-1
Not in Commercial Distribution

  • 58100013411736 ()
  • 18100013411745 ()

  • 5" X 120"


  • Limb/torso/head restraint, reusable
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