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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 - 07640151086206

J-HOOK
SpineArt SA
ELL-IN 00 40-N
In Commercial Distribution

  • 07640151086206 ()
ELL-IN 00 40-N

  • Orthopaedic inorganic implant inserter/extractor, reusable

ROMEO 2 INSTRUMENTATION - 07640151086190

ROD PUSHER
SpineArt SA
ELL-IN 00 39-N
In Commercial Distribution

  • 07640151086190 ()
ELL-IN 00 39-N

  • Orthopaedic rod reducer

ROMEO 2 INSTRUMENTATION - 07640151085988

CANNULATED TAP Ø 6.5 x 30
SpineArt SA
MIS-IN 47 07-N
In Commercial Distribution

  • 07640151085988 ()
MIS-IN 47 07-N

  • Bone tap, reusable

ROMEO 2 INSTRUMENTATION - 07640151085971

CANNULATED TAP Ø 5.5 x 30
SpineArt SA
MIS-IN 47 06-N
In Commercial Distribution

  • 07640151085971 ()
MIS-IN 47 06-N

  • Bone tap, reusable

ROMEO 2 INSTRUMENTATION - 07640151085964

CANNULATED TAP Ø 4.5 x 30
SpineArt SA
MIS-IN 47 05-N
In Commercial Distribution

  • 07640151085964 ()
MIS-IN 47 05-N

  • Bone tap, reusable

ROMEO 2 INSTRUMENTATION - 07640151084585

IMPLANT HOLDER
SpineArt SA
ELL-IN 01 04-N
In Commercial Distribution

  • 07640151084585 ()
ELL-IN 01 04-N

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

ROMEO 2 INSTRUMENTATION - 07640151084318

UNCLIPPER SLEEVE
SpineArt SA
MIS-IN 49 00-N
In Commercial Distribution

  • 07640151084318 ()
MIS-IN 49 00-N

  • Orthopaedic implantation sleeve, reusable

ROMEO 2 INSTRUMENTATION - 07640151084301

SCREW DISTRACTOR
SpineArt SA
ELL-IN 00 21-N
In Commercial Distribution

  • 07640151084301 ()
ELL-IN 00 21-N

  • Surgical retraction system, reusable

ROMEO 2 INSTRUMENTATION - 07640151084295

DILATOR TUBE 4 SERRATED WITH RETENTION FACES
SpineArt SA
MIS-IN 06 05-N
In Commercial Distribution

  • 07640151084295 ()
MIS-IN 06 05-N

  • Orthopaedic implantation sleeve, reusable

ROMEO 2 INSTRUMENTATION - 07640151084288

DILATOR TUBE 4 SERRATED PEEK CARBON
SpineArt SA
MIS-IN 06 04-N
In Commercial Distribution

  • 07640151084288 ()
MIS-IN 06 04-N

  • Orthopaedic implantation sleeve, reusable
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