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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
PRO-DEX, INC.
05.000.021S
In Commercial Distribution

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


  • Disposable battery pack
No Description
PRO-DEX, INC.
05.000.020
In Commercial Distribution

  • 00862377000102 ()


  • 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
ORTHOGNATHIC, SURGICAL PLANNING KIT W/ 3D PRINTED TITANIUM PLATES AND TITANIUM HYBRID GUIDES, SINGLE JAW
Medcad
MC-KTP010-H
In Commercial Distribution

  • 00864582000298 ()
MC-KTP010-H

  • Dental milling system, CAD/CAM, laboratory
  • Custom-made organ/bone anatomy model/surgical guide kit
  • Craniofacial fixation plate, non-bioabsorbable, non-customized
ORTHOGNATHIC, SURGICAL PLANNING KIT W/ 3D PRINTED TITANIUM PLATES AND TITANIUM GUIDES, SINGLE JAW
Medcad
MC-KTP010
In Commercial Distribution

  • 00864582000281 ()
MC-KTP010

  • Craniofacial fixation plate, non-bioabsorbable, non-customized
  • Custom-made organ/bone anatomy model/surgical guide kit
  • Dental milling system, CAD/CAM, laboratory
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
Nylon Facing For #1 Mallet
HU-FRIEDY MFG. CO., LLC
PTNFM1
Not in Commercial Distribution

  • 10889950020668 ()
PTNFM1

  • Surgical mallet
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
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