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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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ASTRA-OCT Spine System - M824A3R400601

ASTRA-OCT Dia. 4mm Ti Straight Rod, 60mm
SPINECRAFT, LLC
A3R-40-060
Not in Commercial Distribution

  • 00193082082023 ()
  • M824A3R400601 ()
A3R-40-060

  • Bone-screw internal spinal fixation system rod

ASTRA-OCT Spine System - M824A3R40050K1

ASTRA-OCT Dia. 4mm CoCr Straight Rod, 50mm
SPINECRAFT, LLC
A3R-40-050K
Not in Commercial Distribution

  • 00193082082597 ()
  • M824A3R40050K1 ()
A3R-40-050K

  • Bone-screw internal spinal fixation system rod

ASTRA-OCT Spine System - M824A3R400501

ASTRA-OCT Dia. 4mm Ti Straight Rod, 50mm
SPINECRAFT, LLC
A3R-40-050
Not in Commercial Distribution

  • 00193082082016 ()
  • M824A3R400501 ()
A3R-40-050

  • Bone-screw internal spinal fixation system rod

ASTRA-OCT Spine System - M824A3R40045K1

ASTRA-OCT Dia. 4mm CoCr Straight Rod, 45mm
SPINECRAFT, LLC
A3R-40-045K
Not in Commercial Distribution

  • 00193082082580 ()
  • M824A3R40045K1 ()
A3R-40-045K

  • Bone-screw internal spinal fixation system rod

ASTRA-OCT Spine System - M824A3R400451

ASTRA-OCT Dia. 4mm Ti Straight Rod, 45mm
SPINECRAFT, LLC
A3R-40-045
Not in Commercial Distribution

  • 00193082082009 ()
  • M824A3R400451 ()
A3R-40-045

  • Bone-screw internal spinal fixation system rod

ASTRA-OCT Spine System - M824A3R40040K1

ASTRA-OCT Dia. 4mm CoCr Straight Rod, 40mm
SPINECRAFT, LLC
A3R-40-040K
Not in Commercial Distribution

  • 00193082082573 ()
  • M824A3R40040K1 ()
A3R-40-040K

  • Bone-screw internal spinal fixation system rod

ASTRA-OCT Spine System - M824A3R400401

ASTRA-OCT Dia. 4mm Ti Straight Rod, 40mm
SPINECRAFT, LLC
A3R-40-040
Not in Commercial Distribution

  • 00193082081996 ()
  • M824A3R400401 ()
A3R-40-040

  • Bone-screw internal spinal fixation system rod

ASTRA-OCT Spine System - M824A3P45421

ASTRA-OCT Dia. 4.5mm Polyaxial Screw, 42mm
SPINECRAFT, LLC
A3P-4542
Not in Commercial Distribution

  • 00193082079986 ()
  • M824A3P45421 ()
A3P-4542

  • Spinal bone screw, non-bioabsorbable

ASTRA-OCT Spine System - M824A3P4540R1

ASTRA-OCT Dia. 4.5mm Polyaxial Reduction Screw, 40mm
SPINECRAFT, LLC
A3P-4540R
Not in Commercial Distribution

  • 00193082080760 ()
  • M824A3P4540R1 ()
A3P-4540R

  • Spinal bone screw, non-bioabsorbable

ASTRA-OCT Spine System - M824A3P45401

ASTRA-OCT Dia. 4.5mm Polyaxial Screw, 40mm
SPINECRAFT, LLC
A3P-4540
Not in Commercial Distribution

  • 00193082079979 ()
  • M824A3P45401 ()
A3P-4540

  • Spinal bone screw, non-bioabsorbable
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