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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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TrackX - 00850073646038

TrackX adapter that enables physicians to more adequately track INSIGHT SNAPs that are placed on instruments that undergo heavier malleting forces.
TrackX Technology, LLC
TrackX Modular Malleting Adapter
In Commercial Distribution

  • 00850073646038 ()
TX-3-4369

  • Diagnostic x-ray digital imaging system workstation application software

ReWalk(TM) Personal 6.0 - 00861803000303

Powered Exoskeleton - community use
LIFEWARD LTD
50-20-0004
In Commercial Distribution

  • 00861803000303 ()


  • Programmable ambulation exoskeleton, home-use

Natus - 05713315008672

Acculink Software
Natus Medical Denmark ApS
8-49-88800
In Commercial Distribution

  • 05713315008672 ()
8-49-88800

  • Evoked-potential audiometer

Natus - 05713315008665

AccuScreen PRO Ear Couplers (25 sets of 2)
Natus Medical Denmark ApS
8-66-22500
In Commercial Distribution

  • 05713315008658 ()
  • 05713315008665 ()
8-66-22500

  • Evoked-potential audiometer

Natus - 05713315008641

AccuScreen Ear Couplers (25 sets of 2)
Natus Medical Denmark ApS
8-66-22410
In Commercial Distribution

  • 05713315008641 ()
  • 05713315008634 ()
8-66-22410

  • Evoked-potential audiometer

KONQUEST - 00869378000445

DIGITAL WRIST BLOOD PRESSURE MONITOR
KONQUEST GROUP INC
KBP-2910W
In Commercial Distribution

  • 00869378000445 ()


  • Patient monitoring system module, blood pressure, noninvasive

KONQUEST - 00869378000438

DIGITAL ARM BLOOD PRESSURE MONITOR
KONQUEST GROUP INC
KBP-2704A
In Commercial Distribution

  • 00869378000438 ()


  • Patient monitoring system module, blood pressure, noninvasive

ReWalk(TM) Personal - 00861803000310

Powered exoskeleton - community use
LIFEWARD LTD
50-20-0002
In Commercial Distribution

  • 00861803000310 ()


  • Programmable ambulation exoskeleton, home-use

MedOne - 00864243000407

Blood Pressure Monitor
MEDONE LLC
JPD-900W
In Commercial Distribution

  • 00864243000407 ()


  • Patient monitoring system module, blood pressure, noninvasive

SNAP Patient Engagement - 00863157000374

Surgical Navigation Advanced Platform (SNAP) Patient Engagement Mobile System
SURGICAL THEATER LLC
PE SNAP
In Commercial Distribution

  • 00863157000374 ()


  • Surgical planning/navigation-enhancement system
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