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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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Mobile application phone
MC10, INC.
BRCP01
Not in Commercial Distribution

  • B493BRCP01 ()


  • Kinesiology/electromyographic sensor set
  • Kinesiology ambulatory recorder
  • Electromyography telemetric monitoring system transmitter
  • Electrocardiography telemetric monitoring system transmitter
  • Biomechanical function analysis/rehabilitation software
Link Hub smart charger
MC10, INC.
BRCD02
Not in Commercial Distribution

  • B493BRCD02 ()


  • Kinesiology/electromyographic sensor set
  • Kinesiology ambulatory recorder
  • Electromyography telemetric monitoring system transmitter
  • Electrocardiography telemetric monitoring system transmitter
  • Biomechanical function analysis/rehabilitation software
Link Hub smart charger
MC10, INC.
BRCD01
Not in Commercial Distribution

  • B493BRCD01 ()


  • Kinesiology/electromyographic sensor set
  • Kinesiology ambulatory recorder
  • Electromyography telemetric monitoring system transmitter
  • Electrocardiography telemetric monitoring system transmitter
  • Biomechanical function analysis/rehabilitation software
Adhesive applicator
MC10, INC.
BRCA05
Not in Commercial Distribution

  • B493BRCA05 ()


  • Kinesiology/electromyographic sensor set
  • Kinesiology ambulatory recorder
  • Electromyography telemetric monitoring system transmitter
  • Electrocardiography telemetric monitoring system transmitter
  • Biomechanical function analysis/rehabilitation software
Maxfax Set Basic
Bioplate, Inc.
K248-50
In Commercial Distribution

  • M384K248500 ()
K248-50

  • Orthopaedic implantable-device cutter
  • Dressing/utility forceps, tweezers-like, reusable
  • Surgical screwdriver, reusable
  • Fluted surgical drill bit, single-use
  • Instrument tray, reusable
The g.Estim FES is a programmable constant-current stimulator that can deliver electrical pulses with alternating polarities, lengths, amplitudes as well as trains of such pulses. The applied part is galvanic isolated. The stimulator is powered by a combination of USB bus-power and battery power. The host computer must use Microsoft Windows. The stimulator is controlled via a software API that uses a USB connection. A host application can be situated on top of the API and can control the stimulator.
g.tec medical engineering GmbH
TD 1.x
In Commercial Distribution

  • EBCI11700 ()
1170

  • Physical therapy transcutaneous neuromuscular electrical stimulation system
Compact Plus Kit Low Profile System
Bioplate, Inc.
81-3367
In Commercial Distribution

  • M3848133670 ()
81-3367

  • Craniofacial fixation plate, non-bioabsorbable, non-customized
  • Craniofacial bone screw, non-bioabsorbable
  • Surgical screwdriver, reusable
  • Instrument tray, reusable
  • Dressing/utility forceps, tweezers-like, reusable
Xpress® Compact Kit
Bioplate, Inc.
81-3364
In Commercial Distribution

  • M3848133640 ()
81-3364

  • Craniofacial fixation plate, non-bioabsorbable, non-customized
  • Craniofacial bone screw, non-bioabsorbable
  • Surgical screwdriver, reusable
  • Instrument tray, reusable
  • Dressing/utility forceps, tweezers-like, reusable
Compact Plus Kit ø1.9mm System
Bioplate, Inc.
81-3342
In Commercial Distribution

  • M3848133420 ()
81-3342

  • Craniofacial fixation plate, non-bioabsorbable, non-customized
  • Craniofacial bone screw, non-bioabsorbable
  • Surgical screwdriver, reusable
  • Instrument tray, reusable
  • Dressing/utility forceps, tweezers-like, reusable
Compact Plus Kit ø1.5mm System
Bioplate, Inc.
81-3340
In Commercial Distribution

  • M3848133400 ()
81-3340

  • Craniofacial fixation plate, non-bioabsorbable, non-customized
  • Craniofacial bone screw, non-bioabsorbable
  • Surgical screwdriver, reusable
  • Instrument tray, reusable
  • Dressing/utility forceps, tweezers-like, reusable
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