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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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FiberTak with SutureTape
ARTHREX, INC.
AR-3602
In Commercial Distribution

  • 00888867206946 ()
  • M150AR36021 ()
  • 10888867206943 ()
AR-3602

  • Tendon/ligament bone anchor, non-bioabsorbable
ZebraProbe with Flushport
ARTHREX, INC.
AR-10500F
In Commercial Distribution

  • 00888867347731 ()
AR-10500F

  • Surgical drill guide, reusable
Adhesive with hydrogel
MC10, INC.
BRCA02
Not in Commercial Distribution

  • B493MC0009 ()
  • B493BRCA02 ()


  • Biomechanical function analysis/rehabilitation software
  • Electromyography telemetric monitoring system transmitter
  • Electrocardiography telemetric monitoring system transmitter
  • Kinesiology/electromyographic sensor set
  • Kinesiology ambulatory recorder
nGenuity with Printer
CRITICARE TECHNOLOGIES, INC.
nGenuity 8100EP
In Commercial Distribution

  • B4388100EPUS0 ()


  • General-purpose multi-parameter bedside monitor
nGenuity with CO2
CRITICARE TECHNOLOGIES, INC.
nGenuity 8100E1
In Commercial Distribution

  • B4388100E1US0 ()


  • General-purpose multi-parameter bedside monitor
SPEEDRIVER WITH T-HANDLE
MEDICREA INTERNATIONAL
A02230080
Not in Commercial Distribution

  • 03613720240846 ()


  • Orthopaedic inorganic implant inserter/extractor, reusable
Standard with grip
Advanced Bionics, LLC
CI-5711-210
In Commercial Distribution



  • Cochlear implant/auditory brainstem implant sound processor earhook
Small with grip
Advanced Bionics, LLC
CI-5711-200
In Commercial Distribution



  • Cochlear implant/auditory brainstem implant sound processor earhook
with Vaginal Sensor
Laborie Medical Technologies Canada ULC
PRN09301
In Commercial Distribution

  • 10627825006283 ()


  • Perineometer
with Anal Sensor
Laborie Medical Technologies Canada ULC
PRN09300
In Commercial Distribution

  • 10627825006276 ()


  • Perineometer
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