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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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FINAL TIGHTENER 13 HEXALOBE
SpineArt SA
ELL-IN 00 50-N
In Commercial Distribution

  • 07640178982048 ()
ELL-IN 00 50-N

  • Surgical screwdriver, reusable
PEDICLE PROBE LENKE STRAIGHT
SpineArt SA
ELL-IN 02 26-N
In Commercial Distribution

  • 07640178981959 ()
ELL-IN 02 26-N

  • Bone awl, reusable
PEDICLE PROBE LENKE CURVED
SpineArt SA
ELL-IN 02 25-N
In Commercial Distribution

  • 07640178981942 ()
ELL-IN 02 25-N

  • Bone awl, reusable
PEDICLE PROBE STRAIGHT
SpineArt SA
ELL-IN 02 24-N
In Commercial Distribution

  • 07640178981935 ()
ELL-IN 02 24-N

  • Bone awl, reusable
DEROTATION HANDLE
SpineArt SA
SPE-IN 01 80-N
In Commercial Distribution

  • 07640178981928 ()
SPE-IN 01 80-N

  • Surgical instrument handle, non-torque-limiting
ROD TRIAL LONG
SpineArt SA
ELL-IN 24 02-N
In Commercial Distribution

  • 07640178981829 ()
ELL-IN 24 02-N

  • Spinal implant trial
QR REDUCER Ti
SpineArt SA
SPE-IN 00 70-N
In Commercial Distribution

  • 07640178974845 ()
SPE-IN 00 70-N

  • Orthopaedic rod reducer
SETSCREW HOLDER
SpineArt SA
ELL-IN 04 10-N
In Commercial Distribution

  • 07640178973862 ()
ELL-IN 04 10-N

  • Surgical implant/trial-implant/sizer holder, reusable
FINAL TIGHTENER
SpineArt SA
ELL-IN 08 06-N
In Commercial Distribution

  • 07640178973855 ()
ELL-IN 08 06-N

  • Surgical screwdriver, reusable
SETSCREW TIGHTENER
SpineArt SA
ELL-IN 07 06-N
In Commercial Distribution

  • 07640178973848 ()
ELL-IN 07 06-N

  • Surgical screwdriver, reusable
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