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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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BURR HOLE COVER, 0.5 MM CONTOUR, PLLA-PGA
KLS-Martin L.P.
52-812-24-04
In Commercial Distribution

  • 00888118085603 ()

  • 5 HOLE, 22 MM DIA, T=1.0 MM


  • Craniofacial fixation plate, bioabsorbable
SCREW, HEX, RED 2, MIDFACE FIXATION, 2.5 MM HEX DRIVER, TI-6AL-4V
KLS-Martin L.P.
51-581-21-09
In Commercial Distribution

  • 00888118082763 ()

  • 2.0 X 7 MM THD, TTL=21 MM


  • Implantable craniofacial bone distractor
SCREW, HEX, RED 2, MIDFACE FIXATION, 2.5 MM HEX DRIVER, TI-6AL-4V
KLS-Martin L.P.
51-581-15-09
In Commercial Distribution

  • 00888118082756 ()

  • 2.0 X 5 MM THD, TTL=15 MM


  • Implantable craniofacial bone distractor
SCREW, HEX, RED 2, MIDFACE FIXATION, HABAL, 2.5 MM HEX DRIVER, TI-6AL-4V
KLS-Martin L.P.
51-581-10-09
In Commercial Distribution

  • 00888118082749 ()

  • 2.0 X 7.5 MM THD, TTL=10.5 MM


  • Implantable craniofacial bone distractor
SCREW, HEX, RED 2, MIDFACE FIXATION, HABAL, 2.5 MM HEX DRIVER, TI-6AL-4V
KLS-Martin L.P.
51-581-08-09
In Commercial Distribution

  • 00888118082732 ()

  • 2.0 X 5 MM THD, TTL= 8 MM


  • Implantable craniofacial bone distractor
PLATE, FRACTURE, STR, 2.3 MM SCREW, TI-6AL-4V
KLS-Martin L.P.
51-213-27-09
Not in Commercial Distribution

  • 00888118080370 ()

  • 27 HOLE, T=1.5 MM


  • Craniofacial fixation plate, non-bioabsorbable, non-customized
PLATE, FRACTURE, LOWER SYMPHYSIS, SMART, 2.3 MM SCREW, TI-6AL-4V
KLS-Martin L.P.
51-212-18-09
Not in Commercial Distribution

  • 00888118080363 ()

  • 18 HOLE, T=1.5 MM


  • Craniofacial fixation plate, non-bioabsorbable, non-customized
PLATE, FRACTURE, UPPER SYMPHYSIS, SMART, 2.3 MM SCREW, TI-6AL-4V
KLS-Martin L.P.
51-212-17-09
Not in Commercial Distribution

  • 00888118080356 ()

  • 17 HOLE, T=1.5 MM


  • Craniofacial fixation plate, non-bioabsorbable, non-customized
PLATE, FRACTURE, LOWER RAMUS, SMART, LEFT, 2.3 MM SCREW, TI-6AL-4V
KLS-Martin L.P.
51-211-19-09
Not in Commercial Distribution

  • 00888118080349 ()

  • 19 HOLE, T=1.5 MM


  • Craniofacial fixation plate, non-bioabsorbable, non-customized
PLATE, FRACTURE, UPPER RAMUS, SMART, LEFT, 2.3 MM SCREW, TI-6AL-4V
KLS-Martin L.P.
51-211-17-09
Not in Commercial Distribution

  • 00888118080332 ()

  • 17 HOLE, T=1.5 MM


  • Craniofacial fixation plate, non-bioabsorbable, non-customized
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