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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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Elite 2 System - 00821925003484

Elite 2 System Rotating Continuous Flow Resectoscope Inner Sheath 25.6 Fr (8.5 mm)
Gyrus ACMI, LLC
E2RIS-CF25
In Commercial Distribution

  • 00821925003484 ()


  • Endoscope sheath, reusable

Elite 2 System - 00821925003477

Elite 2 System Continuous Flow Resectoscope Outer Sheath 27.5 Fr (9.2 mm)
Gyrus ACMI, LLC
E2OS-CF27
In Commercial Distribution

  • 00821925003477 ()


  • Endoscope sheath, reusable

Elite 2 System - 00821925003408

Elite 2 System Continuous Flow Resectoscope Outer Sheath 25.6 Fr (8.5 mm)
Gyrus ACMI, LLC
E2OS-CF25
In Commercial Distribution

  • 00821925003408 ()


  • Endoscope sheath, reusable

Elite 2 System - 00821925003392

Elite 2 System Continuous Flow Resectoscope Inner Sheath 27.5 Fr (9.2 mm)
Gyrus ACMI, LLC
E2IS-CF27
In Commercial Distribution

  • 00821925003392 ()


  • Endoscope sheath, reusable

ROMEO 2 INSTRUMENTATION - 07640185341456

Nav. Drill Sleeve
SpineArt SA
NAV-IN 20 02-N
In Commercial Distribution

  • 07640185341456 ()
NAV-IN 20 02-N

  • Orthopaedic implantation sleeve, reusable

ROMEO 2 INSTRUMENTATION - 07640185340916

SETSCREW STARTER, LONG
SpineArt SA
SPE-US 00 15-N
In Commercial Distribution

  • 07640185340916 ()
SPE-US 00 15-N

  • Surgical screwdriver, reusable

Pattern PIP 2 - 07640181161485

No Description
Keri Medical SA
211-A20002
In Commercial Distribution

  • 07640181161485 ()


  • Orthopaedic surgical procedure kit, non-medicated, reusable

ROMEO 2 INSTRUMENTATION - 07640178989689

INSTRUMENTATION RACK / SUPERIOR
SpineArt SA
MIS-BX 11 01-N
In Commercial Distribution

  • 07640178989689 ()
MIS-BX 11 01-N

  • Instrument tray, reusable

ROMEO 2 INSTRUMENTATION - 07640178989672

TUBE RACK
SpineArt SA
MIS-BX 10 03-N
In Commercial Distribution

  • 07640178989672 ()
MIS-BX 10 03-N

  • Instrument tray, reusable

ROMEO 2 INSTRUMENTATION - 07640178989658

INSTRUMENTATION RACK - APPROACH
SpineArt SA
MIS-BX 10 01-N
In Commercial Distribution

  • 07640178989658 ()
MIS-BX 10 01-N

  • Instrument tray, reusable
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