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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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FilmArray® 2.0 Instrument NGDS Configuration - 00851458005143

NGDS FilmArray Configuration kit (no computer included).
BIOFIRE DEFENSE, LLC
NGDS-ASY-0004
In Commercial Distribution

  • 00851458005143 ()
NGDS-ASY-0004

  • Thermal cycler nucleic acid amplification analyser IVD, laboratory

MammoScreen - B885MAML2US0

Radiological computer assisted detection and diagnosis software
THERAPIXEL
MAL2US
In Commercial Distribution

  • B885MAML2US0 ()


  • X-ray image interpretive software

MammoScreen - B885MAML0

Radiological computer assisted detection and diagnosis software
THERAPIXEL
MAML
In Commercial Distribution

  • B885MAML0 ()
MAML

  • X-ray image interpretive software

BD FocalPoint™ GS Review Station - 00382904901899

BD FocalPoint™ GS Review Station Computer
BECTON, DICKINSON AND COMPANY
490189
In Commercial Distribution

  • 00382904901899 ()

  • Height: 33.2 Centimeter
  • Width: 55 Centimeter
  • Length: 59.2 Centimeter
490189

  • Cell morphology analyser IVD, manual

CompuFlo Epidural Computer Controlled Anesthesia System - 00618874116040

CompuFlo Epidural Computer Controlled Anesthesia System 220V
Milestone Scientific Inc.
EPI-6000-220
In Commercial Distribution

  • 00618874116040 ()


  • Electronic epidural space locator control unit

CompuFlo Epidural Computer Controlled Anesthesia System - 00618874116033

CompuFlo Epidural Computer Controlled Anesthesia System 110V
Milestone Scientific Inc.
EPI-6000-110
In Commercial Distribution

  • 00618874116033 ()


  • Electronic epidural space locator control unit

Esteem® Intraoperative System Analyzer - 00812282020160

Intraoperative System Analyzer (ISA), Software and Computer
Envoy Medical Corporation
3001
In Commercial Distribution

  • 00812282020160 ()
903001-003

  • Fully-implantable middle ear implant system

Vita LE CR System - 60889971067708

NB VITA LE CR SOLUTION W / COMPUTER
CARESTREAM HEALTH, INC.
Vita LE CR System
In Commercial Distribution

  • 60889971067708 ()
1067701

  • Computed radiography digital imaging scanner

Vita XE CR System - 60889971067685

NB VITA XE CR SOLUTION W / COMPUTER
CARESTREAM HEALTH, INC.
Vita XE CR System
In Commercial Distribution

  • 60889971067685 ()
1067685

  • Computed radiography digital imaging scanner

vMap Disposables - 00860007954108

No Description
Vektor Medical, Inc.
VMDISP1
In Commercial Distribution

  • 00860007954108 ()


  • Cardiac mapping system computer
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