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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 - M824A3P4018RS1

ASTRA-OCT Dia. 4.0mm Polyaxial Reduction Smooth Shank Screw, 18mm
SPINECRAFT, LLC
A3P-4018R-S
Not in Commercial Distribution

  • 00193082081491 ()
  • M824A3P4018RS1 ()
A3P-4018R-S

  • Spinal bone screw, non-bioabsorbable

ASTRA-OCT Spine System - M824A3P40101

ASTRA-OCT Dia. 4.0mm Polyaxial Screw, 10mm
SPINECRAFT, LLC
A3P-4010
Not in Commercial Distribution

  • 00193082079610 ()
  • M824A3P40101 ()
A3P-4010

  • Spinal bone screw, non-bioabsorbable

ASTRA-OCT Spine System - M824A3P3550S1

ASTRA-OCT Dia. 3.5mm Polyaxial Smooth Shank Screw, 50mm
SPINECRAFT, LLC
A3P-3550-S
Not in Commercial Distribution

  • 00193082081149 ()
  • M824A3P3550S1 ()
A3P-3550-S

  • Spinal bone screw, non-bioabsorbable

ASTRA-OCT Spine System - M824A3P3550R1

ASTRA-OCT Dia. 3.5mm Polyaxial Reduction Screw, 50mm
SPINECRAFT, LLC
A3P-3550R
Not in Commercial Distribution

  • 00193082080395 ()
  • M824A3P3550R1 ()
A3P-3550R

  • Spinal bone screw, non-bioabsorbable

ASTRA-OCT Spine System - M824A3P3548S1

ASTRA-OCT Dia. 3.5mm Polyaxial Smooth Shank Screw, 48mm
SPINECRAFT, LLC
A3P-3548-S
Not in Commercial Distribution

  • 00193082081132 ()
  • M824A3P3548S1 ()
A3P-3548-S

  • Spinal bone screw, non-bioabsorbable

ASTRA-OCT Spine System - M824A3P3548R1

ASTRA-OCT Dia. 3.5mm Polyaxial Reduction Screw, 48mm
SPINECRAFT, LLC
A3P-3548R
Not in Commercial Distribution

  • 00193082080388 ()
  • M824A3P3548R1 ()
A3P-3548R

  • Spinal bone screw, non-bioabsorbable

ASTRA-OCT Spine System - M824A3P3546S1

ASTRA-OCT Dia. 3.5mm Polyaxial Smooth Shank Screw, 46mm
SPINECRAFT, LLC
A3P-3546-S
Not in Commercial Distribution

  • 00193082081125 ()
  • M824A3P3546S1 ()
A3P-3546-S

  • Spinal bone screw, non-bioabsorbable

ASTRA-OCT Spine System - M824A3P3536RS1

ASTRA-OCT Dia. 3.5mm Polyaxial Reduction Smooth Shank Screw, 36mm
SPINECRAFT, LLC
A3P-3536R-S
Not in Commercial Distribution

  • 00193082081415 ()
  • M824A3P3536RS1 ()
A3P-3536R-S

  • Spinal bone screw, non-bioabsorbable

ASTRA-OCT Spine System - M824A3P3536R1

ASTRA-OCT Dia. 3.5mm Polyaxial Reduction Screw, 36mm
SPINECRAFT, LLC
A3P-3536R
Not in Commercial Distribution

  • 00193082080326 ()
  • M824A3P3536R1 ()
A3P-3536R

  • Spinal bone screw, non-bioabsorbable

ASTRA-OCT Spine System - M824A3P3534RS1

ASTRA-OCT Dia. 3.5mm Polyaxial Reduction Smooth Shank Screw, 34mm
SPINECRAFT, LLC
A3P-3534R-S
Not in Commercial Distribution

  • 00193082081408 ()
  • M824A3P3534RS1 ()
A3P-3534R-S

  • Spinal bone screw, non-bioabsorbable
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