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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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MONARCH SPINE SYSTEM TORQUE WRENCH-SHAFT 9.53mm
DEPUY SPINE, LLC
277040540
Not in Commercial Distribution

  • 10705034196817 ()
277040540

  • Orthopaedic implant driver
MONARCH SPINE SYSTEM TORQUE WRENCH-SHAFT 8mm
DEPUY SPINE, LLC
277040530
Not in Commercial Distribution

  • 10705034196800 ()
277040530

  • Orthopaedic implant driver
MONARCH SPINE SYSTEM MODULAR HEXLOBE DRIVER x25
Medos International Sàrl
277040525
In Commercial Distribution

  • 10705034196794 ()
277040525

  • Orthopaedic implant driver
MONARCH SPINE SYSTEM TORQUE WRENCH, HEXLOBE SHAFT
Medos International Sàrl
277040520
In Commercial Distribution

  • 10705034196787 ()
277040520

  • Orthopaedic implant driver
MONARCH SPINE SYSTEM T-HANDLE NUT TIGHTENER 8mm
DEPUY SPINE, LLC
277040500
Not in Commercial Distribution

  • 10705034196763 ()
277040500

  • Orthopaedic implant driver
MONARCH SPINE SYSTEM HEXLOBE DRIVER x25
DEPUY SPINE, LLC
277040415
In Commercial Distribution

  • 10705034196749 ()
277040415

  • Orthopaedic implant driver
MONARCH SPINE SYSTEM HEXLOBE DRIVER x20
DEPUY SPINE, LLC
277040400
Not in Commercial Distribution

  • 10705034196718 ()
277040400

  • Orthopaedic implant driver
MONARCH SPINE SYSTEM WASHER,INSERTER,SPACER
DEPUY SPINE, LLC
277040220
Not in Commercial Distribution

  • 10705034196701 ()
277040220

  • Orthopaedic inorganic implant inserter/extractor, reusable
MONARCH SPINE SYSTEM MONOAXIAL DRIVER 5.5mm
DEPUY SPINE, LLC
277020120
Not in Commercial Distribution

  • 10705034196558 ()
277020120

  • Surgical screwdriver, reusable
MONARCH SPINE SYSTEM MONOAXIAL DRIVER
DEPUY SPINE, LLC
277020110
Not in Commercial Distribution

  • 10705034196534 ()
277020110

  • Surgical screwdriver, reusable
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