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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 - M824A3RT45325K1

ASTRA-OCT Dia. 4mm CoCr Transition Rod, Dia. 4mm to Dia. 5.5mm, 325mm
SPINECRAFT, LLC
A3R-T45-325K
Not in Commercial Distribution

  • 00193082082719 ()
  • M824A3RT45325K1 ()
A3R-T45-325K

  • Bone-screw internal spinal fixation system rod

ASTRA-OCT Spine System - M824A3RT453251

ASTRA-OCT Dia. 4mm Ti Transition Rod, Dia. 4mm to Dia. 5.5mm, 325mm
SPINECRAFT, LLC
A3R-T45-325
Not in Commercial Distribution

  • 00193082082139 ()
  • M824A3RT453251 ()
A3R-T45-325

  • Bone-screw internal spinal fixation system rod

ASTRA-OCT Spine System - M824A3RT44500K1

ASTRA-OCT Dia. 4mm CoCr Transition Rod, Dia. 4mm to Dia. 4.5mm, 500mm
SPINECRAFT, LLC
A3R-T44-500K
Not in Commercial Distribution

  • 00193082082702 ()
  • M824A3RT44500K1 ()
A3R-T44-500K

  • Bone-screw internal spinal fixation system rod

ASTRA-OCT Spine System - M824A3RT445001

ASTRA-OCT Dia. 4mm Ti Transition Rod, Dia. 4mm to Dia. 4.5mm, 500mm
SPINECRAFT, LLC
A3R-T44-500
Not in Commercial Distribution

  • 00193082082122 ()
  • M824A3RT445001 ()
A3R-T44-500

  • Bone-screw internal spinal fixation system rod

ASTRA-OCT Spine System - M824A3RT44325K1

ASTRA-OCT Dia. 4mm CoCr Transition Rod, Dia. 4mm to Dia. 4.5mm, 325mm
SPINECRAFT, LLC
A3R-T44-325K
Not in Commercial Distribution

  • 00193082082696 ()
  • M824A3RT44325K1 ()
A3R-T44-325K

  • Bone-screw internal spinal fixation system rod

ASTRA-OCT Spine System - M824A3RT443251

ASTRA-OCT Dia. 4mm Ti Rod, Dia. 4mm to Dia. 4.5mm, 325mm
SPINECRAFT, LLC
A3R-T44-325
Not in Commercial Distribution

  • 00193082082115 ()
  • M824A3RT443251 ()
A3R-T44-325

  • Bone-screw internal spinal fixation system rod

ASTRA-OCT Spine System - M824A3RT35500K1

ASTRA-OCT Dia. 3.5mm CoCr Transition Rod, Dia. 3.5mm to Dia. 5.5mm, 500mm
SPINECRAFT, LLC
A3R-T35-500K
Not in Commercial Distribution

  • 00193082082436 ()
  • M824A3RT35500K1 ()
A3R-T35-500K

  • Bone-screw internal spinal fixation system rod

ASTRA-OCT Spine System - M824A3RT355001

ASTRA-OCT Dia. 3.5mm Ti Transition Rod, Dia. 3.5mm to Dia. 5.5mm, 500mm
SPINECRAFT, LLC
A3R-T35-500
Not in Commercial Distribution

  • 00193082081859 ()
  • M824A3RT355001 ()
A3R-T35-500

  • Bone-screw internal spinal fixation system rod

ASTRA-OCT Spine System - M824A3RT35325K1

ASTRA-OCT Dia. 3.5mm CoCr Transition Rod, Dia. 3.5mm to Dia. 5.5mm, 325mm
SPINECRAFT, LLC
A3R-T35-325K
Not in Commercial Distribution

  • 00193082082429 ()
  • M824A3RT35325K1 ()
A3R-T35-325K

  • Bone-screw internal spinal fixation system rod

ASTRA-OCT Spine System - M824A3RT353251

ASTRA-OCT Dia. 3.5mm Ti Transition Rod, Dia. 3.5mm to Dia. 5.5mm, 325mm
SPINECRAFT, LLC
A3R-T35-325
Not in Commercial Distribution

  • 00193082081842 ()
  • M824A3RT353251 ()
A3R-T35-325

  • Bone-screw internal spinal fixation system rod

ASTRA-OCT Spine System - M824A3RT34500K1

ASTRA-OCT Dia. 3.5mm CoCr Transition Rod, Dia. 3.5mm to Dia. 4.5mm, 500mm
SPINECRAFT, LLC
A3R-T34-500K
Not in Commercial Distribution

  • 00193082082412 ()
  • M824A3RT34500K1 ()
A3R-T34-500K

  • Bone-screw internal spinal fixation system rod

ASTRA-OCT Spine System - M824A3RT345001

ASTRA-OCT Dia. 3.5mm Ti Transition Rod, Dia. 3.5mm to Dia. 4.5mm, 500mm
SPINECRAFT, LLC
A3R-T34-500
Not in Commercial Distribution

  • 00193082081835 ()
  • M824A3RT345001 ()
A3R-T34-500

  • Bone-screw internal spinal fixation system rod

ASTRA-OCT Spine System - M824A3RT34325K1

ASTRA-OCT Dia. 3.5mm CoCr Transition Rod, Dia. 3.5mm to Dia. 4.5mm, 325mm
SPINECRAFT, LLC
A3R-T34-325K
Not in Commercial Distribution

  • 00193082082405 ()
  • M824A3RT34325K1 ()
A3R-T34-325K

  • Bone-screw internal spinal fixation system rod

ASTRA-OCT Spine System - M824A3RT343251

ASTRA-OCT Dia. 3.5mm Ti Transition Rod, Dia. 3.5mm to Dia. 4.5mm, 325mm
SPINECRAFT, LLC
A3R-T34-325
Not in Commercial Distribution

  • 00193082081828 ()
  • M824A3RT343251 ()
A3R-T34-325

  • Bone-screw internal spinal fixation system rod

ASTRA-OCT Spine System - M824A3R40450K1

ASTRA-OCT Dia. 4mm CoCr Straight Rod, 450mm
SPINECRAFT, LLC
A3R-40-450K
Not in Commercial Distribution

  • 00193082082689 ()
  • M824A3R40450K1 ()
A3R-40-450K

  • Bone-screw internal spinal fixation system rod

ASTRA-OCT Spine System - M824A3R404501

ASTRA-OCT Dia. 4mm Ti Straight Rod, 450mm
SPINECRAFT, LLC
A3R-40-450
Not in Commercial Distribution

  • 00193082082108 ()
  • M824A3R404501 ()
A3R-40-450

  • Bone-screw internal spinal fixation system rod

ASTRA-OCT Spine System - M824A3R40325K1

ASTRA-OCT Dia. 4mm CoCr Straight Rod, 325mm
SPINECRAFT, LLC
A3R-40-325K
Not in Commercial Distribution

  • 00193082082672 ()
  • M824A3R40325K1 ()
A3R-40-325K

  • Bone-screw internal spinal fixation system rod

ASTRA-OCT Spine System - M824A3R403251

ASTRA-OCT Dia. 4mm Ti Straight Rod, 325mm
SPINECRAFT, LLC
A3R-40-325
Not in Commercial Distribution

  • 00193082082092 ()
  • M824A3R403251 ()
A3R-40-325

  • Bone-screw internal spinal fixation system rod

ASTRA-OCT Spine System - M824A3R40300K1

ASTRA-OCT Dia. 4mm CoCr Straight Rod, 300mm
SPINECRAFT, LLC
A3R-40-300K
Not in Commercial Distribution

  • 00193082082665 ()
  • M824A3R40300K1 ()
A3R-40-300K

  • Bone-screw internal spinal fixation system rod

ASTRA-OCT Spine System - M824A3R403001

ASTRA-OCT Dia. 4mm Ti Straight Rod, 300mm
SPINECRAFT, LLC
A3R-40-300
Not in Commercial Distribution

  • 00193082082085 ()
  • M824A3R403001 ()
A3R-40-300

  • Bone-screw internal spinal fixation system rod

ASTRA-OCT Spine System - M824A3R40200K1

ASTRA-OCT Dia. 4mm CoCr Straight Rod, 200mm
SPINECRAFT, LLC
A3R-40-200K
Not in Commercial Distribution

  • 00193082082658 ()
  • M824A3R40200K1 ()
A3R-40-200K

  • Bone-screw internal spinal fixation system rod

ASTRA-OCT Spine System - M824A3R402001

ASTRA-OCT Dia. 4mm Ti Straight Rod, 200mm
SPINECRAFT, LLC
A3R-40-200
Not in Commercial Distribution

  • 00193082082078 ()
  • M824A3R402001 ()
A3R-40-200

  • Bone-screw internal spinal fixation system rod

ASTRA-OCT Spine System - M824A3R40100K1

ASTRA-OCT Dia. 4mm CoCr Straight Rod, 100mm
SPINECRAFT, LLC
A3R-40-100K
Not in Commercial Distribution

  • 00193082082641 ()
  • M824A3R40100K1 ()
A3R-40-100K

  • Bone-screw internal spinal fixation system rod

ASTRA-OCT Spine System - M824A3P4044RS1

ASTRA-OCT Dia. 4.0mm Polyaxial Reduction Smooth Shank Screw, 44mm
SPINECRAFT, LLC
A3P-4044R-S
Not in Commercial Distribution

  • 00193082081620 ()
  • M824A3P4044RS1 ()
A3P-4044R-S

  • Spinal bone screw, non-bioabsorbable

ASTRA-OCT Spine System - M824A3P3540R1

ASTRA-OCT Dia. 3.5mm Polyaxial Reduction Screw, 40mm
SPINECRAFT, LLC
A3P-3540R
Not in Commercial Distribution

  • 00193082080340 ()
  • M824A3P3540R1 ()
A3P-3540R

  • Spinal bone screw, non-bioabsorbable

ASTRA-OCT Spine System - M824A3P35401

ASTRA-OCT Dia. 3.5mm Polyaxial Screw, 40mm
SPINECRAFT, LLC
A3P-3540
Not in Commercial Distribution

  • 00193082079559 ()
  • M824A3P35401 ()
A3P-3540

  • Spinal bone screw, non-bioabsorbable

ASTRA-OCT Spine System - M824A3P3538S1

ASTRA-OCT Dia. 3.5mm Polyaxial Smooth Shank Screw, 38mm
SPINECRAFT, LLC
A3P-3538-S
Not in Commercial Distribution

  • 00193082081088 ()
  • M824A3P3538S1 ()
A3P-3538-S

  • Spinal bone screw, non-bioabsorbable

ASTRA-OCT Spine System - M824A3P3538RS1

ASTRA-OCT Dia. 3.5mm Polyaxial Reduction Smooth Shank Screw, 38mm
SPINECRAFT, LLC
A3P-3538R-S
Not in Commercial Distribution

  • 00193082081422 ()
  • M824A3P3538RS1 ()
A3P-3538R-S

  • Spinal bone screw, non-bioabsorbable

ASTRA-OCT Spine System - M824A3P3538R1

ASTRA-OCT Dia. 3.5mm Polyaxial Reduction Screw, 38mm
SPINECRAFT, LLC
A3P-3538R
Not in Commercial Distribution

  • 00193082080333 ()
  • M824A3P3538R1 ()
A3P-3538R

  • Spinal bone screw, non-bioabsorbable

ASTRA-OCT Spine System - M824A3P35381

ASTRA-OCT Dia. 3.5mm Polyaxial Screw, 38mm
SPINECRAFT, LLC
A3P-3538
Not in Commercial Distribution

  • 00193082079542 ()
  • M824A3P35381 ()
A3P-3538

  • Spinal bone screw, non-bioabsorbable
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