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 Class Implantable

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Concave reamer Ø18
NOVASTEP
XRE01019
In Commercial Distribution

  • 03700879512419 ()
XRE01019

  • Cannulated surgical drill bit, reusable
Convex reamer Ø22
NOVASTEP
XRE01018
In Commercial Distribution

  • 03700879512402 ()
XRE01018

  • Cannulated surgical drill bit, reusable
Convex reamer Ø20
NOVASTEP
XRE01017
In Commercial Distribution

  • 03700879512396 ()
XRE01017

  • Cannulated surgical drill bit, reusable
Convex reamer Ø18
NOVASTEP
XRE01016
In Commercial Distribution

  • 03700879512389 ()
XRE01016

  • Cannulated surgical drill bit, reusable
Bunion implant Ø4 lg58
NOVASTEP
PS050058
In Commercial Distribution

  • 03700879512365 ()
PS050058

  • Orthopaedic bone screw (non-sliding)
Bunion implant Ø4 lg56
NOVASTEP
PS050056
In Commercial Distribution

  • 03700879512358 ()
PS050056

  • Orthopaedic bone screw (non-sliding)
countersink Single use
NOVASTEP
XRE01022D
In Commercial Distribution

  • 03700879512341 ()
XRE01022D

  • Cannulated surgical drill bit, single-use
Centrolock temporary fixation pin
NOVASTEP
XPP01005
Not in Commercial Distribution

  • 03700879512334 ()
XPP01005

  • General internal orthopaedic fixation system implantation kit
Cortical screw Ø2 lg24
NOVASTEP
SP032024
In Commercial Distribution

  • 03700879512327 ()
SP032024

  • Orthopaedic bone screw (non-sliding)
Locking screw Ø2.5 lg26
NOVASTEP
SP012526
In Commercial Distribution

  • 03700879512310 ()
SP012526

  • Orthopaedic bone screw (non-sliding)
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