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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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Trigno Avanti Sensor, 4-Pack - 00851679007407

Biofeedback Device
DELSYS, INC.
SP-W11
In Commercial Distribution

  • 00851679007407 ()


  • Psychophysiological biofeedback system

Trigno Wireless Biofeedback System - 00851679007391

Biofeedback Device
DELSYS, INC.
DS-T04
In Commercial Distribution

  • 00851679007391 ()


  • Psychophysiological biofeedback system

Trigno Charge-16 - 00851679007384

Biofeedback Device.
DELSYS, INC.
SP-W09
In Commercial Distribution

  • 00851679007384 ()


  • Psychophysiological biofeedback system

Trigno Centro - 00851679007377

Biofeedback Device.
DELSYS, INC.
SP-W10
In Commercial Distribution

  • 00851679007377 ()


  • Psychophysiological biofeedback system

Trigno Avanti Sensor - 00851679007360

Biofeedback Device
DELSYS, INC.
SP-W11
In Commercial Distribution

  • 00851679007360 ()


  • Psychophysiological biofeedback system

Trigno Maize Sensor - 00851679007353

Trigno Wireless Biofeedback System component.
DELSYS, INC.
SP-W06-029
In Commercial Distribution

  • 00851679007353 ()


  • Psychophysiological biofeedback system

Trigno Avanti Duo Sensor - 00851679007346

Trigno System Component
DELSYS, INC.
SP-W06-027
In Commercial Distribution

  • 00851679007346 ()


  • Psychophysiological biofeedback system

Trigno Avanti EKG Biofeedback Sensor - 00851679007339

Trigno System Component
DELSYS, INC.
SP-W06-021
In Commercial Distribution

  • 00851679007339 ()


  • Psychophysiological biofeedback system

Trigno Avanti Load Cell Adapter - 00851679007322

Trigno System Component
DELSYS, INC.
SP-W06-022
In Commercial Distribution

  • 00851679007322 ()


  • Psychophysiological biofeedback system

Trigno Avanti Goniometer Adapter - 00851679007315

Trigno System Component
DELSYS, INC.
SP-W06-023
In Commercial Distribution

  • 00851679007315 ()


  • Psychophysiological biofeedback system

Trigno Avanti Analog Input Adapter - 00851679007308

Trigno System Component
DELSYS, INC.
SP-W06-025
In Commercial Distribution

  • 00851679007308 ()


  • Psychophysiological biofeedback system

Trigno Avanti FSR Adapter - 00851679007292

Trigno System Component
DELSYS, INC.
SP-W06-020
In Commercial Distribution

  • 00851679007292 ()


  • Psychophysiological biofeedback system

Trigno Avanti Spring Contact Adapter - 00851679007285

Trigno System Component
DELSYS, INC.
SP-W06-019
In Commercial Distribution

  • 00851679007285 ()


  • Psychophysiological biofeedback system

Trigno Avanti 12-inch Snap Lead EMG Sensor - 00851679007261

Trigno System Component
DELSYS, INC.
SP-W06-018B
In Commercial Distribution

  • 00851679007261 ()


  • Psychophysiological biofeedback system

Trigno Avanti Snap Lead EMG Sensor - 00851679007254

Trigno System Component
DELSYS, INC.
SP-W06-018A
In Commercial Distribution

  • 00851679007254 ()


  • Psychophysiological biofeedback system

Trigno Avanti Mini Sensor - 00851679007247

Trigno System Component
DELSYS, INC.
SP-W06-024
In Commercial Distribution

  • 00851679007247 ()


  • Psychophysiological biofeedback system

Trigno Quattro Sensor - 00851679007230

Trigno System Component
DELSYS, INC.
SP-W06-016
In Commercial Distribution

  • 00851679007230 ()


  • Psychophysiological biofeedback system

Trigno Galileo Sensor - 00851679007223

Trigno System Component
DELSYS, INC.
SP-W06-017
In Commercial Distribution

  • 00851679007223 ()


  • Psychophysiological biofeedback system

Axon - 09413000107500

Axon Neurofeedback software Application for iOS
EXSURGO LIMITED
iOS
In Commercial Distribution

  • 09413000107500 ()
100318

  • Psychophysiological biofeedback system

Axon 2 - 09413000095982

EEG-based Neurofeedback Headset for use with the Axon mobile App, enabling users to modulate and redirect brain activity towards frequencies associated with relaxation and calm focused attention.
EXSURGO LIMITED
100500
In Commercial Distribution

  • 09413000095982 ()
100500

  • Psychophysiological biofeedback system

Axon - 09413000078510

Neurofeedback Software Application for Android
EXSURGO LIMITED
Android
In Commercial Distribution

  • 09413000078510 ()
100321

  • Psychophysiological biofeedback system

Axon - 09413000078459

EEG Biofeedback (Neurofeedback) Kit - Large includes Axon EEG headset - Large, Tablet with Axon Neurofeedback Software Application
EXSURGO LIMITED
Large
Not in Commercial Distribution

  • 09413000078459 ()
100161

  • Psychophysiological biofeedback system

Axon - 09413000078442

Neurofeedback Kit - Medium includes Axon EEG headset - Medium, Tablet with Axon Neurofeedback Software Application
EXSURGO LIMITED
Medium
Not in Commercial Distribution

  • 09413000078442 ()
100160

  • Psychophysiological biofeedback system

Axon - 09413000078435

Neurofeedback Kit - Small includes Axon EEG headset - Small, Tablet with Axon Neurofeedback Software Application
EXSURGO LIMITED
Small
Not in Commercial Distribution

  • 09413000078435 ()
100140

  • Psychophysiological biofeedback system

Axon - 09413000078428

EEG Headset - Large
EXSURGO LIMITED
Large
Not in Commercial Distribution

  • 09413000078428 ()
100143

  • Psychophysiological biofeedback system

Axon - 09413000078411

EEG Headset - Small
EXSURGO LIMITED
Small
Not in Commercial Distribution

  • 09413000078411 ()
100141

  • Psychophysiological biofeedback system

Axon - 09413000077094

EEG Headset - Medium
EXSURGO LIMITED
Medium
Not in Commercial Distribution

  • 09413000077094 ()
100142

  • Psychophysiological biofeedback system

Recording Cap G1 - 08592566829345

82-934
DEYMED Diagnostic s.r.o.
L (23“ - 25“)
In Commercial Distribution

  • 08592566829345 ()
82-934

  • Psychophysiological biofeedback system

Recording Cap G1 - 08592566829321

82-932
DEYMED Diagnostic s.r.o.
S (20“ - 21.5“)
In Commercial Distribution

  • 08592566829321 ()
82-932

  • Psychophysiological biofeedback system

FlexiCAP - 08592566829178

Size L 59-63 cm, 23-25 in
DEYMED Diagnostic s.r.o.
Size L 59-63 cm, 23-25 in
In Commercial Distribution

  • 08592566829178 ()
82-917

  • Psychophysiological biofeedback system

Ear Electrode Sn (Tin) - 08592566639029

63-902
DEYMED Diagnostic s.r.o.
blue, 1.5 m
In Commercial Distribution

  • 08592566639029 ()
63-902

  • Psychophysiological biofeedback system

Ear Electrode Sn (Tin) - 08592566639005

63-900
DEYMED Diagnostic s.r.o.
white, 1.5 m
In Commercial Distribution

  • 08592566639005 ()
63-900

  • Psychophysiological biofeedback system

Recording Cap G1 - 08592566629341

Neurofeedback device accessories
DEYMED Diagnostic s.r.o.
L (23“ - 25“)
In Commercial Distribution

  • 08592566629341 ()
62-934

  • Psychophysiological biofeedback system

Recording Cap G1 - 08592566629334

Neurofeedback device accessories
DEYMED Diagnostic s.r.o.
M (21.5“ - 23“)
In Commercial Distribution

  • 08592566629334 ()
62-933

  • Psychophysiological biofeedback system

Recording Cap G1 - 08592566629327

Neurofeedback device accessories
DEYMED Diagnostic s.r.o.
S (20“ - 21.5“)
In Commercial Distribution

  • 08592566629327 ()
62-932

  • Psychophysiological biofeedback system

Recording Cap G1 - 08592566629310

Neurofeedback device accessories
DEYMED Diagnostic s.r.o.
XS (18.5“ - 20“)
In Commercial Distribution

  • 08592566629310 ()
62-931

  • Psychophysiological biofeedback system

Cable for connection - 08592566629181

Neurofeedback device accessories
DEYMED Diagnostic s.r.o.
32ch FlexiCap 62-91X
In Commercial Distribution

  • 08592566629181 ()
62-918

  • Psychophysiological biofeedback system

FlexiCAP - 08592566629174

Neurofeedback device accessories
DEYMED Diagnostic s.r.o.
L (59 – 63 cm, blue)
In Commercial Distribution

  • 08592566629174 ()
62-917

  • Psychophysiological biofeedback system

FlexiCAP - 08592566629167

Neurofeedback device accessories
DEYMED Diagnostic s.r.o.
M (55 – 59 cm, red)
In Commercial Distribution

  • 08592566629167 ()
62-916

  • Psychophysiological biofeedback system

FlexiCAP - 08592566629150

Neurofeedback device accessories
DEYMED Diagnostic s.r.o.
S (51 – 55 cm, yellow)
In Commercial Distribution

  • 08592566629150 ()
62-915

  • Psychophysiological biofeedback system

FlexiCAP - 08592566629143

Neurofeedback device accessories
DEYMED Diagnostic s.r.o.
XS (47 – 51 cm, green)
In Commercial Distribution

  • 08592566629143 ()
62-914

  • Psychophysiological biofeedback system

FlexiCAP - 08592566629136

Neurofeedback device accessories
DEYMED Diagnostic s.r.o.
L (59 – 63 cm, blue), 32 channels, layout 06
In Commercial Distribution

  • 08592566629136 ()
62-913

  • Psychophysiological biofeedback system

FlexiCAP - 08592566629129

Neurofeedback device accessories
DEYMED Diagnostic s.r.o.
M (55 – 59 cm, red), 32 channels, layout 06
In Commercial Distribution

  • 08592566629129 ()
62-912

  • Psychophysiological biofeedback system

FlexiCAP - 08592566629112

Neurofeedback device accessories
DEYMED Diagnostic s.r.o.
S (51 – 55 cm, yellow), 32 channels, layout 06
In Commercial Distribution

  • 08592566629112 ()
62-911

  • Psychophysiological biofeedback system

FlexiCAP - 08592566629105

Neurofeedback device accessories
DEYMED Diagnostic s.r.o.
XS (47 – 51 cm, green), 32 channels, layout 06
In Commercial Distribution

  • 08592566629105 ()
62-910

  • Psychophysiological biofeedback system

TruScan Neurofeedback Explorer - 08592566509506

50-950
DEYMED Diagnostic s.r.o.
50-950
In Commercial Distribution

  • 08592566509506 ()
50-950

  • Psychophysiological biofeedback system

TruScan Neurofeedback Acquisition - 08592566509001

50-900
DEYMED Diagnostic s.r.o.
50-900
In Commercial Distribution

  • 08592566509001 ()
50-900

  • Psychophysiological biofeedback system

TruScan Neurofeedback optical cable V3.3L - 08592566449000

44-900
DEYMED Diagnostic s.r.o.
44-900
In Commercial Distribution

  • 08592566449000 ()
44-900

  • Psychophysiological biofeedback system

Set for the application of EEG recording gel - 08592566001192

Neurofeedback device accessories
DEYMED Diagnostic s.r.o.
In Commercial Distribution

  • 08592566001192 ()
00-119

  • Psychophysiological biofeedback system

Disc Electrode 9mm Sn (Tin) - 08592566001161

Neurofeedback device accessories
DEYMED Diagnostic s.r.o.
mix 25pcs
In Commercial Distribution

  • 08592566001161 ()
00-116

  • Psychophysiological biofeedback system
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