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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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BROACH WITH PILOT 12MM
Synthes GmbH
SD389.809
In Commercial Distribution

  • H981SD3898090 ()
  • 10705034708188 ()
SD389809

  • Orthopaedic broach
BROACH WITH PILOT 10MM
Synthes GmbH
SD389.808
In Commercial Distribution

  • H981SD3898080 ()
  • 10705034708171 ()
SD389808

  • Orthopaedic broach
BROACH WITH PILOT 8MM
Synthes GmbH
SD389.807
In Commercial Distribution

  • H981SD3898070 ()
  • 10705034708164 ()
SD389807

  • Orthopaedic broach
BROACH WITH PILOT 6MM
Synthes GmbH
SD389.806
In Commercial Distribution

  • H981SD3898060 ()
  • 10705034708157 ()
SD389806

  • Orthopaedic broach
AWL-CYLINDRICAL TIP WITH GRADUATIONS
Synthes GmbH
SD388.656
In Commercial Distribution

  • H981SD3886560 ()
  • 10705034707150 ()
SD388656

  • Bone awl, reusable
SYNFIX DRILL WITH HANDLE-3.0MM
Synthes GmbH
SD03.802.230
In Commercial Distribution

  • H981SD038022300 ()
  • 10705034703640 ()
SD03802230

  • Fluted surgical drill bit, reusable
OSTEOTOME WITH GUIDE PIN-10MM
SYNTHES (U.S.A.) LP
SD03.632.311
Not in Commercial Distribution

  • H981SD036323110 ()
  • 10705034703008 ()
SD03632311

  • Orthopaedic osteotome
Alignment Rods with Coupling-Long
Ortho Development Corporation
261-0032-01
In Commercial Distribution

  • 00822409047086 ()
261-0032-01

  • Osteotomy guide, reusable
Alignment Rod with Coupling
Ortho Development Corporation
261-0032
In Commercial Distribution

  • 00822409047079 ()
261-0032

  • Osteotomy guide, reusable
SYNFIX REAMER WITH U-JOINT
Synthes GmbH
SD391.009
In Commercial Distribution

  • H981SD3910090 ()
  • 10705034708706 ()
SD391009

  • Bone-resection orthopaedic reamer, reusable
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