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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Reduction device double tip
NOVASTEP
XMS01027
In Commercial Distribution

  • 03700879511009 ()
XMS01027

  • General internal orthopaedic fixation system implantation kit
Single-Use MTP Reamer 22mm
NOVASTEP
SUI04022
In Commercial Distribution

  • 03700879510996 ()
SUI04022

  • Cannulated surgical drill bit, single-use
Single-Use MTP Reamer 20mm
NOVASTEP
SUI04020
In Commercial Distribution

  • 03700879510989 ()
SUI04020

  • Cannulated surgical drill bit, single-use
Single-Use MTP Reamer 18mm
NOVASTEP
SUI04018
In Commercial Distribution

  • 03700879510972 ()
SUI04018

  • Cannulated surgical drill bit, single-use
Opened Arms Distractor
NOVASTEP
XFP01008
In Commercial Distribution

  • 03700879510965 ()
XFP01008

  • General internal orthopaedic fixation system implantation kit
Airlock sterile Single Use Lisfranc plate trials
NOVASTEP
SUI03005
Not in Commercial Distribution

  • 03700879510958 ()
SUI03005

  • Orthopaedic surgical procedure kit, non-medicated, single-use
Reduction wire Ø3.5
NOVASTEP
CKW03001
In Commercial Distribution

  • 03700879510941 ()
CKW03001

  • Orthopaedic intraoperative positioning pin, single-use
K-wire holder
NOVASTEP
ACC1001P0018
In Commercial Distribution

  • 03700879510934 ()
ACC1001P0018

  • Device sterilization/disinfection container, reusable
Lisfranc T Long trial plate
NOVASTEP
XTI05050
In Commercial Distribution

  • 03700879510927 ()
XTI05050

  • Surgical implant template, reusable
Lisfranc T Short trial plate
NOVASTEP
XTI05040
In Commercial Distribution

  • 03700879510910 ()
XTI05040

  • Surgical implant template, reusable
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