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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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ORTHOGNATHIC, SURGICAL PLANNING KIT W/ 3D PRINTED TITANIUM PLATES AND TITANIUM HYBRID GUIDES
Medcad
MC-KTP000-H
In Commercial Distribution

  • 00864582000274 ()
MC-KTP000-H

  • Dental milling system, CAD/CAM, laboratory
  • Custom-made organ/bone anatomy model/surgical guide kit
  • Craniofacial fixation plate, non-bioabsorbable, non-customized
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
PRO-DEX, INC.
KLS-SD-1000-NTL
In Commercial Distribution

  • 00862377000188 ()


  • Bone/joint surgical power tool motorized handpiece/set, electric, reusable
No Description
PRO-DEX, INC.
APD-1000-1
In Commercial Distribution

  • 00862377000164 ()


  • Bone/joint surgical power tool motorized handpiece/set, electric, reusable
No Description
PRO-DEX, INC.
APD-SC-001
In Commercial Distribution

  • 00860540000294 ()


  • Device sterilization/disinfection container, reusable
No Description
PRO-DEX, INC.
05.000.020LN
In Commercial Distribution

  • 00860540000225 ()


  • Bone/joint surgical power tool motorized handpiece/set, electric, reusable
Ball Hex Driver 6mm, Teardrop
Orthalign, Inc.
403211
In Commercial Distribution

  • 00858704006756 ()
403211

  • Orthopaedic surgical procedure kit, non-medicated, reusable
Hex Driver - 3.5mm, Teardrop
Orthalign, Inc.
403105
In Commercial Distribution

  • 00858704006602 ()
403105

  • Orthopaedic surgical procedure kit, non-medicated, reusable
Pin Driver, Tri-Flat, 3.2mm
Orthalign, Inc.
403189
In Commercial Distribution

  • 00858704006435 ()
403189

  • Orthopaedic surgical procedure kit, non-medicated, reusable
Pin Driver
Orthalign, Inc.
402067
In Commercial Distribution

  • 00858704006428 ()
402067

  • Orthopaedic surgical procedure kit, non-medicated, reusable
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