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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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PERLA ® TL MIS - 07640450862648

CALIPER - ARM 1
SpineArt SA
MPF-IN 24 00-N
In Commercial Distribution

  • 07640450862648 ()
MPF-IN 24 00-N

  • Surgical depth gauge, reusable

SCARLET AL-T INSTRUMENTATION - 07640185343344

Cup curette, angled DOWN, size “4”
SpineArt SA
SCA-IN 24 01-N
In Commercial Distribution

  • 07640185343344 ()
SCA-IN 24 01-N

  • Bone curette, reusable

SCARLET AL-T INSTRUMENTATION - 07640185343337

Cup curette, straight, size “4”
SpineArt SA
SCA-IN 24 00-N
In Commercial Distribution

  • 07640185343337 ()
SCA-IN 24 00-N

  • Bone curette, reusable

ROMEO 2 INSTRUMENTATION - 07640178981829

ROD TRIAL LONG
SpineArt SA
ELL-IN 24 02-N
In Commercial Distribution

  • 07640178981829 ()
ELL-IN 24 02-N

  • Spinal implant trial

ROMEO 2 INSTRUMENTATION - 07640178981812

ROD TRIAL SHORT
SpineArt SA
ELL-IN 24 01-N
In Commercial Distribution

  • 07640178981812 ()
ELL-IN 24 01-N

  • Spinal implant trial

ROMEO 2 INSTRUMENTATION - 07640178981805

REAMER
SpineArt SA
ELL-IN 24 00-N
In Commercial Distribution

  • 07640178981805 ()
ELL-IN 24 00-N

  • Bone file/rasp, manual, reusable

The Electrode Store - 00816022020298

Reusable Ground Electrode, 32mm Dia Flat Round Disc w/Tip; Green; 1.5mm
IMPULSE MEDICAL TECHNOLOGIES, INC.
EVR-541(24)S
In Commercial Distribution

  • 00816022020298 ()
EVR-541(24)S

  • Analytical non-scalp cutaneous electrode

PERLA ® - 07640151095307

Sagittal bender left
SpineArt SA
CPF-IN 24 0L-N
Not in Commercial Distribution

  • 07640151095307 ()
CPF-IN 24 0L-N

  • Manual orthopaedic bender, reusable

PERLA ® - 07640151095291

Sagittal bender right
SpineArt SA
CPF-IN 24 0R-N
Not in Commercial Distribution

  • 07640151095291 ()
CPF-IN 24 0R-N

  • Manual orthopaedic bender, reusable

PERLA ® - 07640178975309

Sagittal bender left
SpineArt SA
CPF-IN 24 0L-N
In Commercial Distribution

  • 07640178975309 ()
CPF-IN 24 0L-N

  • Manual orthopaedic bender, reusable
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