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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
Biomet Orthopedics, LLC
424417
In Commercial Distribution

  • 00880304009424 ()
424417

  • Surgical screwdriver, reusable
REVIAN RED is a non-invasive, hands-free device indicated to treat androgenetic alopecia in both men and women. It is operated via a mobile application to promote hair growth using Modulated Light Therapy (MLT) for a recommended 10-minute daily treatment. REVIAN RED is a system comprised of a wearable soft textile Cap using driver electronics,a rechargeable battery, and integrated light emitting diode (LED) flexible printed circuit board. REVIAN RED is designed as an over-the-counter (OTC) home-based device to treat the entire scalp area of the user and is controlled via a wireless Bluetooth connection to a mobile application operating on a wireless device.
Revian, Inc.
101
In Commercial Distribution

  • 00862712000309 ()

  • Width: 20 Centimeter
  • Weight: 155 Gram
  • Length: 22.86 Centimeter
  • Height: 15.87 Centimeter
10001

  • Hair growth laser device
No Description
General Vibronics, LLC
GVM2
In Commercial Distribution

  • 00860013508616 ()


  • Medium-wave diathermy treatment system generator
Maxilla Cutting Guide Ti
Techfit Digital Surgery, Inc.
0
In Commercial Distribution

  • 00860012759460 ()
GCMAXTI

  • Custom-made orthopaedic/craniofacial surgical guide
Mandible Cutting Guide Ti
Techfit Digital Surgery, Inc.
0
In Commercial Distribution

  • 00860012759453 ()
GCMANTI

  • Custom-made orthopaedic/craniofacial surgical guide
Fibula cutting guide Ti
Techfit Digital Surgery, Inc.
0
In Commercial Distribution

  • 00860012759446 ()
GCPTI

  • Custom-made orthopaedic/craniofacial surgical guide
Palatal Orthog Surgical Splint Digital
Techfit Digital Surgery, Inc.
0
In Commercial Distribution

  • 00860012759422 ()
FPCOD

  • Custom-made orthopaedic/craniofacial surgical guide
Interm Orthog Surgical Splint Digital
Techfit Digital Surgery, Inc.
0
In Commercial Distribution

  • 00860012759415 ()
FICOD

  • Custom-made orthopaedic/craniofacial surgical guide
Final Orthog Surgical Splint Digital
Techfit Digital Surgery, Inc.
0
In Commercial Distribution

  • 00860012759408 ()
FFCOD

  • Custom-made orthopaedic/craniofacial surgical guide
Condyle Position Guide - Ti
Techfit Digital Surgery, Inc.
0
In Commercial Distribution

  • 00860011469285 ()
CGPTI

  • Custom-made orthopaedic/craniofacial surgical guide
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