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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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SternalPlate Implant Module with Lid
PARAGON MEDICAL, INC.
4700201
In Commercial Distribution

  • 00857387006466 ()


  • Instrument tray, reusable
TENS Massager with Remote Control
Sharperimage
205073-01
In Commercial Distribution

  • 00856759006844 ()
  • 00854761007071 ()


  • Transcutaneous electrical stimulation electrode, single-use
  • Transcutaneous electrical stimulation lead
  • Physical therapy transcutaneous neuromuscular electrical stimulation system
Smartphone dermatoscope with polarized light
DermLite LLC
DL1B
In Commercial Distribution

  • 00855997006166 ()
DL1B

  • Dermatoscope, optical
KOVA-TROL III 4X15ML WITH/HCG
KOVA INTERNATIONAL, INC.
87331
In Commercial Distribution

  • 00855617006668 ()
87331

  • Urine sediment IVD, control
KOVA-TROL III WITH/HCG 4X60ML
KOVA INTERNATIONAL, INC.
87327
In Commercial Distribution

  • 00855617006644 ()
87327

  • Urine sediment IVD, control
VisionHUB with DynaVision Dynamic sEMG
PRECISION BIOMETRICS INC
D2-D6
In Commercial Distribution

  • 00853818007460 ()
D2-D6

  • Multiple physiological signal amplifier
SERIES-5 VisionHUB with FlexVision Inclinometers
PRECISION BIOMETRICS INC
D2-D5
In Commercial Distribution

  • 00853818007453 ()
D2-D5-D5

  • Multiple physiological signal amplifier
Wireless Monitor with Wall Mount
Parasol Medical, LLC
WPADS-01
In Commercial Distribution

  • 00854636006406 ()


  • Inpatient motion surveillance unit
Wired Monitor with Wall Mount
Parasol Medical, LLC
PADS-01
In Commercial Distribution

  • 00854636006376 ()


  • Inpatient motion surveillance unit
TAP/SCREW SLEEVE WITH WINDOW
MEDTRONIC SOFAMOR DANEK, INC.
X0499007
In Commercial Distribution

  • 00673978138985 ()


  • Orthopaedic implantation sleeve, reusable
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