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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 - M824A3P55351

ASTRA-OCT Dia. 5.5mm Polyaxial Screw, 35mm
SPINECRAFT, LLC
A3P-5535
Not in Commercial Distribution

  • 00193082080159 ()
  • M824A3P55351 ()
A3P-5535

  • Spinal bone screw, non-bioabsorbable

ASTRA-OCT Spine System - M824A3P55301

ASTRA-OCT Dia. 5.5mm Polyaxial Screw, 30mm
SPINECRAFT, LLC
A3P-5530
Not in Commercial Distribution

  • 00193082080142 ()
  • M824A3P55301 ()
A3P-5530

  • Spinal bone screw, non-bioabsorbable

ASTRA-OCT Spine System - M824A3P50451

ASTRA-OCT Dia. 5.0mm Polyaxial Screw, 45mm
SPINECRAFT, LLC
A3P-5045
Not in Commercial Distribution

  • 00193082080098 ()
  • M824A3P50451 ()
A3P-5045

  • Spinal bone screw, non-bioabsorbable

ASTRA-OCT Spine System - M824A3P5040R1

ASTRA-OCT Dia. 5.0mm Polyaxial Reduction Screw, 40mm
SPINECRAFT, LLC
A3P-5040R
Not in Commercial Distribution

  • 00193082080876 ()
  • M824A3P5040R1 ()
A3P-5040R

  • Spinal bone screw, non-bioabsorbable

ASTRA-OCT Spine System - M824A3P50401

ASTRA-OCT Dia. 5.0mm Polyaxial Screw, 40mm
SPINECRAFT, LLC
A3P-5040
Not in Commercial Distribution

  • 00193082080081 ()
  • M824A3P50401 ()
A3P-5040

  • Spinal bone screw, non-bioabsorbable

ASTRA-OCT Spine System - M824A3P50351

ASTRA-OCT Dia. 5.0mm Polyaxial Screw, 35mm
SPINECRAFT, LLC
A3P-5035
Not in Commercial Distribution

  • 00193082080074 ()
  • M824A3P50351 ()
A3P-5035

  • Spinal bone screw, non-bioabsorbable

ASTRA-OCT Spine System - M824A3P50301

ASTRA-OCT Dia. 5.0mm Polyaxial Screw, 30mm
SPINECRAFT, LLC
A3P-5030
Not in Commercial Distribution

  • 00193082080067 ()
  • M824A3P50301 ()
A3P-5030

  • Spinal bone screw, non-bioabsorbable

ASTRA-OCT Spine System - M824A3P50251

ASTRA-OCT Dia. 5.0mm Polyaxial Screw, 25mm
SPINECRAFT, LLC
A3P-5025
Not in Commercial Distribution

  • 00193082080050 ()
  • M824A3P50251 ()
A3P-5025

  • Spinal bone screw, non-bioabsorbable

ASTRA-OCT Spine System - M824A3P50201

ASTRA-OCT Dia. 5.0mm Polyaxial Screw, 20mm
SPINECRAFT, LLC
A3P-5020
Not in Commercial Distribution

  • 00193082080043 ()
  • M824A3P50201 ()
A3P-5020

  • Spinal bone screw, non-bioabsorbable

ASTRA-OCT Spine System - M824A3P5015R1

ASTRA-OCT Dia. 5.0mm Polyaxial Reduction Screw, 15mm
SPINECRAFT, LLC
A3P-5015R
Not in Commercial Distribution

  • 00193082080821 ()
  • M824A3P5015R1 ()
A3P-5015R

  • Spinal bone screw, non-bioabsorbable
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