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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 - M824A3R350301

ASTRA-OCT Dia. 3.5mm Ti Straight Rod, 30mm
SPINECRAFT, LLC
A3R-35-030
In Commercial Distribution

  • 00193082081682 ()
  • M824A3R350301 ()
A3R-35-030

  • Bone-screw internal spinal fixation system, non-sterile

ASTRA-OCT Spine System - M824A3R35025K1

ASTRA-OCT Dia. 3.5mm CoCr Straight Rod, 25mm
SPINECRAFT, LLC
A3R-35-025K
In Commercial Distribution

  • 00193082082252 ()
  • M824A3R35025K1 ()
A3R-35-025K

  • Bone-screw internal spinal fixation system, non-sterile

ASTRA-OCT Spine System - M824A3R350251

ASTRA-OCT Dia. 3.5mm Ti Straight Rod, 25mm
SPINECRAFT, LLC
A3R-35-025
In Commercial Distribution

  • 00193082081675 ()
  • M824A3R350251 ()
A3R-35-025

  • Bone-screw internal spinal fixation system, non-sterile

ASTRA-OCT Spine System - M824A3R35020K1

ASTRA-OCT Dia. 3.5mm CoCr Straight Rod, 20mm
SPINECRAFT, LLC
A3R-35-020K
In Commercial Distribution

  • 00193082082245 ()
  • M824A3R35020K1 ()
A3R-35-020K

  • Bone-screw internal spinal fixation system, non-sterile

ASTRA-OCT Spine System - M824A3R350201

ASTRA-OCT Dia. 3.5mm Ti Straight Rod, 20mm
SPINECRAFT, LLC
A3R-35-020
In Commercial Distribution

  • 00193082081668 ()
  • M824A3R350201 ()
A3R-35-020

  • Bone-screw internal spinal fixation system, non-sterile

ASTRA-OCT Spine System - M824A3P5550R1

ASTRA-OCT Dia. 5.5mm Polyaxial Reduction Screw, 50mm
SPINECRAFT, LLC
A3P-5550R
In Commercial Distribution

  • 00193082080975 ()
  • M824A3P5550R1 ()
A3P-5550R

  • Bone-screw internal spinal fixation system, non-sterile

ASTRA-OCT Spine System - M824A3P55501

ASTRA-OCT Dia. 5.5mm Polyaxial Screw, 50mm
SPINECRAFT, LLC
A3P-5550
In Commercial Distribution

  • 00193082080180 ()
  • M824A3P55501 ()
A3P-5550

  • Bone-screw internal spinal fixation system, non-sterile

ASTRA-OCT Spine System - M824A3P5545R1

ASTRA-OCT Dia. 5.5mm Polyaxial Reduction Screw, 45mm
SPINECRAFT, LLC
A3P-5545R
In Commercial Distribution

  • 00193082080968 ()
  • M824A3P5545R1 ()
A3P-5545R

  • Bone-screw internal spinal fixation system, non-sterile

ASTRA-OCT Spine System - M824A3P55451

ASTRA-OCT Dia. 5.5mm Polyaxial Screw, 45mm
SPINECRAFT, LLC
A3P-5545
In Commercial Distribution

  • 00193082080173 ()
  • M824A3P55451 ()
A3P-5545

  • Bone-screw internal spinal fixation system, non-sterile

ASTRA-OCT Spine System - M824A3P5540R1

ASTRA-OCT Dia. 5.5mm Polyaxial Reduction Screw, 40mm
SPINECRAFT, LLC
A3P-5540R
In Commercial Distribution

  • 00193082080951 ()
  • M824A3P5540R1 ()
A3P-5540R

  • Bone-screw internal spinal fixation system, non-sterile
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