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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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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

LUNA 2 - 09336472028039

LUNA 2 INTRO KT
SDI LIMITED
8452025
In Commercial Distribution

  • 09336472028039 ()
8452025

  • Dental composite resin

LUNA 2 - 09336472027698

LUNA 2 1 SYR A3.5
SDI LIMITED
8452004
In Commercial Distribution

  • 09336472027698 ()
8452004

  • Dental composite resin

MICROLIGHT 2 - 04053755189311

No Description
Heine Optotechnik GmbH & Co. KG
000
In Commercial Distribution

  • 04053755189311 ()
J-008.31.255

  • Head-worn lamp

LOUPELIGHT 2 - 04053755189144

No Description
Heine Optotechnik GmbH & Co. KG
000
In Commercial Distribution

  • 04053755189144 ()
C-008.32.227

  • Head-worn lamp

Vamos 2 - 04048675227489

No Description
Drägerwerk AG & Co. KGaA
6871990
In Commercial Distribution

  • 04048675227489 ()


  • Anaesthetic agent gas monitor, multiple

ONEClamp (2) - 00841439114827

For use with BPL ONE Respiratory Belt or ZiFix Abdominal/Thoracic Motion Control System
MEDTEC, INC.
BPL016
In Commercial Distribution

  • 00841439114827 ()
BPL016

  • Radiological whole-body positioner

Posirest 2 - 00841439100356

Baseplate with headrest, high arm support, cranial arm support and rigid adjustable arm supports with large cups (2)
MEDTEC, INC.
106522
In Commercial Distribution

  • 00841439100356 ()

  • Height: 33.9 Centimeter
  • Length: 73.4 Centimeter
106522

  • Radiological breast positioner, non-wearable

Posirest 2 - 00841439100349

Baseplate with headrest, high arm support, cranial arm support and rigid adjustable arm supports (2)
MEDTEC, INC.
106521
In Commercial Distribution

  • 00841439100349 ()

  • Width: 17.8 Inch
  • Length: 28.4 Inch
106521

  • Radiological breast positioner, non-wearable

Posirest 2 - 00841439100332

Baseplate with headrest, high arm support, cranial arm support and adjustable arm supports (2)
MEDTEC, INC.
106520
In Commercial Distribution

  • 00841439100332 ()

  • Width: 17.8 Inch
  • Length: 25.3 Inch
106520

  • Radiological breast positioner, non-wearable
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