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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
212001240
In Commercial Distribution

  • 00880304814271 ()

  • 2.5MM
212001240

  • Surgical screwdriver, reusable
ACCY KIT 355015 BURR HOLE
MEDTRONIC, INC.
355015
Not in Commercial Distribution

  • 00721902036378 ()


  • Craniofacial fixation plate, non-bioabsorbable, non-customized
No Description
General Vibronics, LLC
GVM2
In Commercial Distribution

  • 00860013508616 ()


  • Medium-wave diathermy treatment system generator
SubQ It! Bioabsorbable Driver SU-10 is a single-patient use, skin closure device, preloaded with 10 bioabsorbable dermal fasteners, packaged sterile in a protective foil pouch.
OPUS KSD, INC.
SU-10
In Commercial Distribution

  • 10867469000234 ()
  • 00867469000237 ()
412010

  • Skin stapler/staple, bioabsorbable
SubQ It! Bioabsorbable Driver SU-10 is a single-patient use, skin closure device, preloaded with 10 bioabsorbable dermal fasteners, packaged sterile in a protective foil pouch.
OPUS KSD, INC.
SU-10
In Commercial Distribution

  • 10867469000227 ()
  • 00867469000220 ()
412010

  • Skin stapler/staple, bioabsorbable
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.
05.000.021S
In Commercial Distribution

  • 00862377000119 ()
  • 10862377000116 ()
  • 20862377000113 ()


  • Disposable battery pack
No Description
Eca Medical Instruments
1005
In Commercial Distribution

  • 00857676008775 ()


  • Cannulated surgical drill bit, single-use
No Description
Eca Medical Instruments
1004-003
In Commercial Distribution

  • 00857676008768 ()


  • Cannulated surgical drill bit, single-use
No Description
Eca Medical Instruments
1004-002
In Commercial Distribution

  • 00857676008751 ()


  • Cannulated surgical drill bit, single-use
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