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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A box of three STEEP SENSIMED Triggerfish® Sensors
Sensimed SA
S.V.4
In Commercial Distribution

  • 07640153470041 ()
BO3S

  • Ocular volume ambulatory recording system sensor
A single unit of FLAT SENSIMED Triggerfish® Sensor
Sensimed SA
F.V.4
In Commercial Distribution

  • 07640153470034 ()

  • Outer Diameter: 14.1 Millimeter
ST1003

  • Ocular volume ambulatory recording system sensor
A single unit of MEDIUM SENSIMED Triggerfish® Sensor
Sensimed SA
M.V.4
In Commercial Distribution

  • 07640153470027 ()

  • Outer Diameter: 14.1 Millimeter
ST1002

  • Ocular volume ambulatory recording system sensor
A single unit of STEEP SENSIMED Triggerfish® Sensor
Sensimed SA
S.V.4
In Commercial Distribution

  • 07640153470010 ()

  • Outer Diameter: 14.1 Millimeter
ST1001

  • Ocular volume ambulatory recording system sensor
No Description
ALPHA OMEGA ENGINEERING CO. LTD.
HaGuide Software
In Commercial Distribution

  • 07290114064071 ()
407-000024-00

  • Brain-responsive electrical stimulation system
No Description
ALPHA OMEGA ENGINEERING CO. LTD.
Neuro Omega ECOG HeadBox Kit
In Commercial Distribution

  • 27290114060800 ()
750-020016-00

  • Brain-responsive electrical stimulation system
pH Recorder refurbished
Given Imaging, Inc.
RFB-0450
In Commercial Distribution

  • 07290101365303 ()


  • Gastrointestinal telemetric monitoring system
Calibration stand Bravo/Digitrapper
Given Imaging, Inc.
FGS-0493
In Commercial Distribution

  • 07290101364283 ()


  • Gastrointestinal telemetric monitoring system
pH recorder
Given Imaging, Inc.
FGS-0450
In Commercial Distribution

  • 07290101363064 ()


  • Gastrointestinal telemetric monitoring system
pH capsule delivery dev, 5-pk
Given Imaging, Inc.
FGS-0312
In Commercial Distribution

  • 07290101361695 ()
  • 10884521740495 ()


  • Gastrointestinal telemetric monitoring system
pH capsule delivery dev, 1-pk
Given Imaging, Inc.
FGS-0313
In Commercial Distribution

  • 07290101361688 ()


  • Gastrointestinal telemetric monitoring system
Buffer, pH 1.07, 500 ml
Given Imaging, Inc.
FGS-0303
In Commercial Distribution

  • 07290101361299 ()


  • Gastrointestinal telemetric monitoring system
Bravo™ CF capsule delivery dev,1-pk
Given Imaging, Inc.
FGS-0636
In Commercial Distribution

  • 07290101369714 ()


  • Gastrointestinal telemetric monitoring system
Bravo CF capsule delivery dev, 5-pk
Given Imaging, Inc.
FGS-0635
In Commercial Distribution

  • 07290101369707 ()
  • 17290101369704 ()


  • Gastrointestinal telemetric monitoring system
Bravo CF reflux recorder
Given Imaging, Inc.
FGS-0634
In Commercial Distribution

  • 07290101369691 ()


  • Gastrointestinal telemetric monitoring system
Smartbar
Given Imaging, Inc.
50100700
In Commercial Distribution

  • 07290101367390 ()


  • Gastrointestinal telemetric monitoring system
pH recorder SW upgrade v136
Given Imaging, Inc.
FGS-0593
In Commercial Distribution

  • 07290101366393 ()


  • Gastrointestinal telemetric monitoring system
pH recorder strap, 5-Pack
Given Imaging, Inc.
FGS-0516
In Commercial Distribution

  • 07290101364771 ()
  • 10884521740488 ()


  • Gastrointestinal telemetric monitoring system
Buffer, pH 7.01, 500 ml
Given Imaging, Inc.
FGS-0302
In Commercial Distribution

  • 07290101361282 ()


  • Gastrointestinal telemetric monitoring system
SmartPill software v3.1
Given Imaging, Inc.
FGS-0658
In Commercial Distribution

  • 07290110360481 ()


  • Gastrointestinal telemetric monitoring system
Reflux software v6.1 upgrade
Given Imaging, Inc.
FGS-0657
In Commercial Distribution

  • 07290110360436 ()


  • Gastrointestinal telemetric monitoring system
Reflux software v6.1
Given Imaging, Inc.
FGS-0656
In Commercial Distribution

  • 07290110360429 ()


  • Gastrointestinal telemetric monitoring system
No Description
TREK DIAGNOSTIC SYSTEMS LIMITED
GPID
In Commercial Distribution

  • M578GPID2 ()
  • M578GPID0 ()


  • Gram positive bacteria species culture isolate identification/antimicrobial susceptibility profile IVD, kit
No Description
TREK DIAGNOSTIC SYSTEMS LIMITED
GNID
In Commercial Distribution

  • M578GNID2 ()
  • M578GNID0 ()


  • Gram positive bacteria species culture isolate identification/antimicrobial susceptibility profile IVD, kit
Codebook Crystal Rgp Manual
BECTON, DICKINSON AND COMPANY
245041
Not in Commercial Distribution

  • 00382902450412 ()
245041

  • Microorganism identification analyser IVD, manual
Codebook Crystal Gram-Positive Manual
BECTON, DICKINSON AND COMPANY
245037
Not in Commercial Distribution

  • 00382902450375 ()
245037

  • Microorganism identification analyser IVD, manual
BD BBL™ CRYSTAL™ Identification Systems Enteric / Nonfermenter
BECTON, DICKINSON AND COMPANY
245002
Not in Commercial Distribution

  • 00382902450023 ()
245002

  • Microorganism identification analyser IVD, manual
PLATE DRY CLI GRAM+ ID AUTO A semi-quantitative test intended for the automated identification of Gram positive bacterial isolates based on biochemical reactions. Used in a diagnostic workflow to aid clinicians in determining potential treatment options for patients suspected of having a microbial infection, the device requires an automated system to produce a result and requires a pure, agar grown culture. This device is for professional use only and is not a companion diagnostic.
REMEL, INC.
GPID
In Commercial Distribution

  • 00848838074363 ()


  • Multiple aerobic gram positive bacteria species culture isolate identification IVD, kit
PLATE DRY CLI GRAM+ ID AUTO -A semi-quantitative test intended for the automated identification of Gram negative bacterial isolates based on biochemical reactions. Used in a diagnostic workflow to aid clinicians in determining potential treatment options for patients suspected of having a microbial infection, the device requires an automated system to produce a result and requires a pure, agar grown culture. This device is for professional use only and is not a companion diagnostic.
REMEL, INC.
GNID
In Commercial Distribution

  • 00848838074325 ()


  • Multiple aerobic gram positive bacteria species culture isolate identification IVD, kit
No Description
OXOID LIMITED
MB1588A
In Commercial Distribution

  • 05032384128013 ()


  • Multiple bacteria species culture isolate identification control IVD, kit
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