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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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Techvision for Ceiling Systm
CARESTREAM HEALTH, INC.
QG-TV-IP-C
In Commercial Distribution

  • 60889971065391 ()
1065390

  • X-ray system computer, diagnostic, general-purpose
E2 MiniSet Fixed Mounting Hardware (pair). Optional mounting hardware for Matrx E2 Backs (16H or less). Requires tools to remove.
Motion Concepts Inc
MSFX
In Commercial Distribution

  • 07540147000882 ()
MSFX

  • Wheelchair back rest positioner
Easy-Set Mounting Hardware (pair) for use on 1-1/4" back canes. Hardware for Matrx Elite and PB Backs. Quick-release design.
Motion Concepts Inc
PBMH-X
In Commercial Distribution

  • 07540147000257 ()
PBMH-X

  • Wheelchair back rest positioner
Easy-Set Mounting Hardware (pair) for use on 1-1/8" back canes. Hardware for Matrx Elite and PB Backs. Quick-release design.
Motion Concepts Inc
PBMH-Q
In Commercial Distribution

  • 07540147000233 ()
PBMH-Q

  • Wheelchair back rest positioner
Integrity
ELEKTA LIMITED
1526754
In Commercial Distribution

  • 05060191071062 ()


  • Accelerator system computer
Medic Vision’s SafeCT-29 provides a vendor-neutral Radiation Dose Check functionality, in accordance with the Dose Check feature that is specified by the NEMA XR-25 Standard. The device is a software and hardware system which includes Computer, dedicated display and controls. The SafeCT-29 is interfaced to CT scanners that are not equipped with the Dose Check function. The device is connected to the CT Console video output via a standard video connector. The SafeCT-29 Computer’s internal video splitter captures the CT Console display video, in real time, without affecting neither the CT console itself nor its display. This analog video signal is digitized by a video grabber. The SafeCT-29 software analyzes the digital input video using OCR software continuously. The radiation dose information as calculated by the scanner and displayed to the CT operator is extracted and analyzed in real time. The SafeCT- 29 captures the video of the CT Console display in real time, without affecting neither the CT console itself nor its display and workflow. As specified by NEMA XR-25 Standard, the safeCT-29 notifies and alerts the CT operators, prior to a scan, if the estimated dose index is above the predefined values set by the operating group, practice, or organization. SafeCT-29 prevents continuing an over-the-limit scan unless dose levels are reconfirmed by the operator, in accordance with NEMA XR-29*.The device records the details of such events, including the operator details and decisions. This record is available to the user.
MEDIC VISION - IMAGING SOLUTIONS LTD
1.0
In Commercial Distribution

  • 07290016836202 ()
  • 00729001683639 ()


  • CT system computer
XR-29 Solution v1.0
AGILITI HEALTH, INC.
v1.0
In Commercial Distribution

  • 00810040260001 ()


  • CT system computer
Wall Cradle, Non-Contact Therm,Acrylic w/hardware & box, RM
AMERICAN DIAGNOSTIC CORP
429CRADLE
In Commercial Distribution

  • 00634782085186 ()
429CRADLE

  • Infrared patient thermometer, skin
Universal Urethane Full Length Arm Pad w/ Hardware (ea)
PROACTIVE MEDICAL PRODUCTS, LLC
PP-RAPUF
In Commercial Distribution

  • 05060488573347 ()

  • Height: 4 Inch
  • Length: 8 Inch
  • Width: 2 Inch
PP-RAPUF

  • Wheelchair armrest
Universal Urethane Desk Length Arm Pad w/ Hardware (ea)
PROACTIVE MEDICAL PRODUCTS, LLC
PP-RAPUD
In Commercial Distribution

  • 05060488573330 ()

  • Width: 2 Inch
  • Height: 4 Inch
  • Length: 8 Inch
PP-RAPUD

  • Wheelchair armrest
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