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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MESH, SMART, ALVEOLAR SHELL, PDLLA
KLS-Martin L.P.
52-301-07-04
In Commercial Distribution

  • 00888118000392 ()

  • 7 X 2.5 MM, T=0.1 MM


  • Craniofacial fixation plate, bioabsorbable
PLATE, BADIE, PDLLA
KLS-Martin L.P.
52-042-22-04
In Commercial Distribution

  • 00888118000149 ()

  • 10 X 5 MM, T=0.3 MM


  • Craniofacial fixation plate, bioabsorbable
PLATE, BADIE, PDLLA
KLS-Martin L.P.
52-042-20-04
In Commercial Distribution

  • 00888118000125 ()

  • 16 X 9 MM, T=0.3 MM


  • Craniofacial fixation plate, bioabsorbable
PLATE, BADIE, PDLLA
KLS-Martin L.P.
52-042-18-04
In Commercial Distribution

  • 00888118000101 ()

  • 10 X 5 MM, T=0.6 MM


  • Craniofacial fixation plate, bioabsorbable
MESH, SMALL GRID, PDLLA
KLS-Martin L.P.
01-310-13-04
Not in Commercial Distribution

  • 00888118000002 ()

  • 126 X 11 MM, T=2.0 MM


  • Craniofacial fixation plate, bioabsorbable
Orthopedic surgical instrument - Cannulated entry drill, 12.5 mm
NUVASIVE SPECIALIZED ORTHOPEDICS, INC.
ERM2-12.5
In Commercial Distribution

  • 00812258029081 ()

  • Tool/Instrument
ERM2-12.5

  • Cannulated surgical drill bit, single-use
Orthopedic surgical instrument - 3.9 mm drill bit, short
NUVASIVE SPECIALIZED ORTHOPEDICS, INC.
DBS2-3.9
In Commercial Distribution

  • 00812258029029 ()

  • Tool/Instrument
DBS2-3.9

  • Cannulated surgical drill bit, single-use
Orthopedic surgical instrument - Cannulated entry drill, 8mm
NUVASIVE SPECIALIZED ORTHOPEDICS, INC.
CED2-008
In Commercial Distribution

  • 00812258028978 ()

  • Tool/Instrument
CED2-008

  • Cannulated surgical drill bit, single-use
Orthopedic surgical instrument (entry drill) - for use with the intramedullary limb lengthening system
NUVASIVE SPECIALIZED ORTHOPEDICS, INC.
CED1-008
In Commercial Distribution

  • 00812258026547 ()

  • Tool/Instrument
CED1-008

  • Cannulated surgical drill bit, single-use
BURR HOLE COVER, 0.5 MM CONTOUR, PLLA-PGA
KLS-Martin L.P.
52-812-19-04
In Commercial Distribution

  • 00888118001597 ()

  • 5 HOLE, 17 MM DIA, T=1.0 MM


  • Craniofacial fixation plate, bioabsorbable
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