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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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FSN - 00810000890040

Wireless Imaging System
FORESEESON CUSTOM DISPLAYS, INC.
WIS4000
In Commercial Distribution

  • 00810000890040 ()
WIS4000

  • Portable computer

Aseptico - 10817417020746

Dental Implant Motor System with Variable-Speed Footswitch. Drive system for instruments and tools used in dentistry for implant procedures.
ASEPTICO, INC.
AEU-1000-70V
In Commercial Distribution

  • 10817417020746 ()
AEU-1000-70V

  • Dental surgical power tool motorized handpiece/set, electric

Mobi-tools - 08436035359592

Kit containing 8 tools, 1 technical manual and 1 bag to keep everything inside, for patient transfer and mobilization
MEDI CARE SYSTEM SLU
TMK6800
In Commercial Distribution

  • 08436035359592 ()


  • Manual patient lifting belt/harness

E2 Easy-Set Fixed Mounting Hardware - 07540147000899

E2 Easy-Set Fixed Mounting Hardware (pair). Optional mounting hardware for Matrx E2 Backs (18H/20H). Requires tools for removal.
Motion Concepts Inc
ESFX
In Commercial Distribution

  • 07540147000899 ()
ESFX

  • Wheelchair back rest positioner

OmniFlow Therapy System - 00858703006276

Software and sensor designed to provide visual feedback to respiratory patients.
ACCELERATED CARE PLUS CORP
100FLO
In Commercial Distribution

  • 00858703006276 ()


  • Bioelectrical signal analysis software
  • Biomechanical function analysis/interactive rehabilitation system
  • Monitoring spirometer, mechanical

DMC-EZ - 00850018049009

DICOM Media Creator - 25 Inkjet
Storage Solutions Technology Group Inc.
DMC-EZ 25
In Commercial Distribution

  • 00850018049009 ()
DMC-EZ 25

  • DICOM image data disc-recording unit

DMC-EZ - 00850018049139

DICOM Media Creator - USB Thermal
Storage Solutions Technology Group Inc.
DMC-EZ USB
In Commercial Distribution

  • 00850018049139 ()
DMC-EZ USB

  • DICOM image data disc-recording unit

DMC-EZ - 00850018049122

DICOM Media Creator - 575 Inkjet
Storage Solutions Technology Group Inc.
DMC-EZ 575
In Commercial Distribution

  • 00850018049122 ()
DMC-EZ 575

  • DICOM image data disc-recording unit

DMC-EZ - 00850018049054

DICOM Media Creator - FLUP
Storage Solutions Technology Group Inc.
DMC-EZ FLUP
In Commercial Distribution

  • 00850018049054 ()
DMC-EZ FLUP

  • DICOM image data disc-recording unit

DMC-EZ - 00850018049047

DICOM Media Creator - 8500 Thermal
Storage Solutions Technology Group Inc.
DMC-EZ 8500
In Commercial Distribution

  • 00850018049047 ()
DMC-EZ 8500

  • DICOM image data disc-recording unit
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