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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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ROMEO 2 INSTRUMENTATION - 07640139349378

K WIRE W / TROCAR TIP
SpineArt SA
MIS-IN 02 01-N
In Commercial Distribution

  • 07640139349378 ()
MIS-IN 02 01-N

  • Orthopaedic bone wire

ROMEO 2 INSTRUMENTATION - 07640139349361

K WIRE BLUNT
SpineArt SA
MIS-IN 02 00-N
In Commercial Distribution

  • 07640139349361 ()
MIS-IN 02 00-N

  • Orthopaedic bone wire

ROMEO 2 INSTRUMENTATION - 07640139344342

Implant holder for monoaxial screw
SpineArt SA
ELL-IN 00 20-N
In Commercial Distribution

  • 07640139344342 ()
ELL-IN 00 20-N

  • Surgical implant/trial-implant/sizer holder, reusable

ROMEO 2 INSTRUMENTATION - 07640139342058

DISTRACTION FORCEPS
SpineArt SA
ELL-IN 00 07-N
In Commercial Distribution

  • 07640139342058 ()
ELL-IN 00 07-N

  • Implant handling forceps, alligator

ROMEO 2 INSTRUMENTATION - 07640139342041

SETSCREW TIGHTENER
SpineArt SA
ELL-IN 00 06-N
In Commercial Distribution

  • 07640139342041 ()
ELL-IN 00 06-N

  • Surgical screwdriver, reusable

ROMEO 2 INSTRUMENTATION - 07640139342034

ROCKER
SpineArt SA
ELL-IN 00 05-N
In Commercial Distribution

  • 07640139342034 ()
ELL-IN 00 05-N

  • Orthopaedic rod reducer

ROMEO 2 INSTRUMENTATION - 07640139342027

ROD HOLDER
SpineArt SA
ELL-IN 00 04-N
In Commercial Distribution

  • 07640139342027 ()
ELL-IN 00 04-N

  • Surgical implant/trial-implant/sizer holder, reusable

ROMEO 2 INSTRUMENTATION - 07640139342010

Implant holder
SpineArt SA
ELL-IN 00 03-N
In Commercial Distribution

  • 07640139342010 ()
ELL-IN 00 03-N

  • General internal orthopaedic fixation system implantation kit

ROMEO 2 INSTRUMENTATION - 07640139342003

PEDICLE SOUNDER
SpineArt SA
ELL-IN 00 02-N
In Commercial Distribution

  • 07640139342003 ()
ELL-IN 00 02-N

  • Abdominal/ENT/orthopaedic surgical probe, reusable

ROMEO 2 INSTRUMENTATION - 07640139341990

SQUARE AWL
SpineArt SA
ELL-IN 00 01-N
In Commercial Distribution

  • 07640139341990 ()
ELL-IN 00 01-N

  • Bone awl, reusable
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