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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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No Description
Exo Imaging, Inc.
EW1001
In Commercial Distribution

  • 00850018318013 ()


  • Ultrasound imaging system application software
VistaScan™ Software 1.x.x
EMAGINE SOLUTIONS TECHNOLOGY LLC
1.x.x
In Commercial Distribution

  • 00850017464001 ()


  • Ultrasound imaging system application software
No Description
RESOUNDANT, INC.
3.0DKR
In Commercial Distribution

  • 00850011790199 ()
MREPLUSV3

  • MRI system application software
No Description
RESOUNDANT, INC.
MREplus 3.0.0WIN
Not in Commercial Distribution

  • 00850011790014 ()


  • MRI system application software
No Description
RESOUNDANT, INC.
MREplus 3.0.0DKR
Not in Commercial Distribution

  • 00850011790007 ()


  • MRI system application software
Inliant System, US, Full Package
Navigate Surgical Technologies Inc
900010-1
In Commercial Distribution

  • 00850049386111 ()
9000101

  • Surgical planning/navigation-enhancement system
Consumable - Fiducial Kit
Navigate Surgical Technologies Inc
900007-0
In Commercial Distribution

  • 00850049386029 ()
9000070

  • Surgical planning/navigation-enhancement system
Edwards TruWave Transducer Adaptor Cable
REMOTE DIAGNOSTIC TECHNOLOGIES LIMITED
01-2111
Not in Commercial Distribution

  • 05060472440730 ()


  • Multiple vital physiological parameter monitoring system, clinical
Utah Deltran Transducer Adaptor Cable
REMOTE DIAGNOSTIC TECHNOLOGIES LIMITED
01-2110
Not in Commercial Distribution

  • 05060472440723 ()


  • Multiple vital physiological parameter monitoring system, clinical
2-Channel Invasive Pressure Universal Cable
REMOTE DIAGNOSTIC TECHNOLOGIES LIMITED
01-2108
In Commercial Distribution

  • 05060472440716 ()


  • Multiple vital physiological parameter monitoring system, clinical
Consumables Replenishment Kit
REMOTE DIAGNOSTIC TECHNOLOGIES LIMITED
01-1020
Not in Commercial Distribution

  • 05060472440709 ()


  • Multiple vital physiological parameter monitoring system, clinical
Mains Power Supply
REMOTE DIAGNOSTIC TECHNOLOGIES LIMITED
01-1017
Not in Commercial Distribution

  • 05060472440693 ()


  • Multiple vital physiological parameter monitoring system, clinical
12-Lead ECG Harness
REMOTE DIAGNOSTIC TECHNOLOGIES LIMITED
01-1010
Not in Commercial Distribution

  • 05060472440686 ()


  • Multiple vital physiological parameter monitoring system, clinical
No Description
REMOTE DIAGNOSTIC TECHNOLOGIES LIMITED
00-1001
Not in Commercial Distribution

  • 05060472440679 ()


  • Multiple vital physiological parameter monitoring system, clinical
No Description
REMOTE DIAGNOSTIC TECHNOLOGIES LIMITED
00-1007
Not in Commercial Distribution

  • 05060472440655 ()


  • Multiple vital physiological parameter monitoring system, clinical
No Description
REMOTE DIAGNOSTIC TECHNOLOGIES LIMITED
00-1006
Not in Commercial Distribution

  • 05060472440648 ()


  • Multiple vital physiological parameter monitoring system, clinical
No Description
REMOTE DIAGNOSTIC TECHNOLOGIES LIMITED
00-1005
Not in Commercial Distribution

  • 05060472440631 ()


  • Multiple vital physiological parameter monitoring system, clinical
No Description
REMOTE DIAGNOSTIC TECHNOLOGIES LIMITED
00-1004
Not in Commercial Distribution

  • 05060472440624 ()


  • Multiple vital physiological parameter monitoring system, clinical
USB Serial Inline Converter Cable
REMOTE DIAGNOSTIC TECHNOLOGIES LIMITED
01-2112
Not in Commercial Distribution

  • 05060472440617 ()


  • Multiple vital physiological parameter monitoring system, clinical
Lo-Flo® Sidestream Capnometer
REMOTE DIAGNOSTIC TECHNOLOGIES LIMITED
01-1005
Not in Commercial Distribution

  • 05060472440600 ()


  • Multiple vital physiological parameter monitoring system, clinical
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