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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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Blood Ketone Monitoring System
Ketobm LLC
KBM-K01
In Commercial Distribution

  • 00860001641752 ()


  • Ketone (acetoacetate) IVD, reagent
DOCS system is an audio/video integration system that is installed in health care facilities where video-assisted procedures are performed. The DOCS system is used by trained health care personnel to route video signals from medical equipment (i.e., endoscopic cameras, C-arms, ultrasound, PACS) to flat-panel monitors for display during procedures.
Cv Medical, LLC
DOCS
In Commercial Distribution

  • 00860001554533 ()


  • Medical image management system
The NuBOOM/DOCS system is an equipment management and audio/video integration system that is installed in health care facilities where video-assisted procedures are performed. The NuBOOM/DOCS system is used by trained health care personnel to route video signals from medical equipment (i.e., endoscopic cameras, C-arms, ultrasound, PACS) to flat-panel monitors for display during procedures. The NuBOOM/DOCS system consists of two major components: an equipment management subsystem and a video integration subsystem. The equipment management subsystem—called the NuBOOM—is a metal superstructure (cabinet) that is anchored to the facility floor. The cabinet provides an attachment point for booms, which support adjustable arms with flat-panel monitors, and shelves for storage of medical equipment. The booms and spring arms can be moved to allow the most ergonomic placement of the flat-panel monitors. The equipment management component of the NuBOOM/DOCS system provides health care staff with an adjustable system that can be configured to the needs of each procedure.
Cv Medical, LLC
U
In Commercial Distribution

  • 00860001554526 ()


  • Medical image management system
The NuCART® is a mobile display and image management platform intended to be used by health care providers in Minimally Invasive Surgery (MIS) environments to facilitate the routing and ergonomic display of video signals from source devices to monitors. It is tailored for use with a C-arm and Endo-Cam in MIS surgery suites, Ambulatory Surgery Centers, Urology, GI and other suites.
Cv Medical, LLC
NuCART
In Commercial Distribution

  • 00860001554519 ()


  • Medical image management system
The NuVIEW® is a mobile visualization platform tailored for use with a C-arm and Patient Monitor in Minimally Invasive Surgery suites, Ambulatory Surgery Centers, Urology, GI and other suites. Designed for mobility and simplicity it will compete with entry level mobile carts. The NuVIEW® product is comprised of Mechanical and Hardware design inputs.
Cv Medical, LLC
NuVIEW
In Commercial Distribution

  • 00860001554502 ()


  • Medical image management system
RestoreX Kit - penile traction therapy device for the treatment of Peyronie's disease. Contains RestoreX device, extension rods, self-adherent wrap, Instructions for Use
PATHRIGHT MEDICAL INC.
117
In Commercial Distribution

  • 00860001453805 ()
117

  • Penile traction splint
No Description
HILL LABORATORIES CO.
HA90
In Commercial Distribution

  • 00860001452594 ()


  • Examination/treatment table, line-powered
No Description
HILL LABORATORIES CO.
HA90C
In Commercial Distribution

  • 00860001452587 ()


  • Examination/treatment table, line-powered
No Description
HILL LABORATORIES CO.
Air Flex II
In Commercial Distribution

  • 00860001452570 ()


  • Body arch traction table
No Description
HILL LABORATORIES CO.
HA90MD
In Commercial Distribution

  • 00860001452563 ()


  • General examination/treatment chair, electric
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