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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 - M824A3P55251

ASTRA-OCT Dia. 5.5mm Polyaxial Screw, 25mm
SPINECRAFT, LLC
A3P-5525
Not in Commercial Distribution

  • 00193082080135 ()
  • M824A3P55251 ()
A3P-5525

  • Spinal bone screw, non-bioabsorbable

ASTRA-OCT Spine System - M824A3P5520R1

ASTRA-OCT Dia. 5.5mm Polyaxial Reduction Screw, 20mm
SPINECRAFT, LLC
A3P-5520R
Not in Commercial Distribution

  • 00193082080913 ()
  • M824A3P5520R1 ()
A3P-5520R

  • Spinal bone screw, non-bioabsorbable

ASTRA-OCT Spine System - M824A3P55201

ASTRA-OCT Dia. 5.5mm Polyaxial Screw, 20mm
SPINECRAFT, LLC
A3P-5520
Not in Commercial Distribution

  • 00193082080128 ()
  • M824A3P55201 ()
A3P-5520

  • Spinal bone screw, non-bioabsorbable

ASTRA-OCT Spine System - M824A3P5515R1

ASTRA-OCT Dia. 5.5mm Polyaxial Reduction Screw, 15mm
SPINECRAFT, LLC
A3P-5515R
Not in Commercial Distribution

  • 00193082080906 ()
  • M824A3P5515R1 ()
A3P-5515R

  • Spinal bone screw, non-bioabsorbable

ASTRA-OCT Spine System - M824A3P55151

ASTRA-OCT Dia. 5.5mm Polyaxial Screw, 15mm
SPINECRAFT, LLC
A3P-5515
Not in Commercial Distribution

  • 00193082080111 ()
  • M824A3P55151 ()
A3P-5515

  • Spinal bone screw, non-bioabsorbable

ASTRA-OCT Spine System - M824A3P5050R1

ASTRA-OCT Dia. 5.0mm Polyaxial Reduction Screw, 50mm
SPINECRAFT, LLC
A3P-5050R
Not in Commercial Distribution

  • 00193082080890 ()
  • M824A3P5050R1 ()
A3P-5050R

  • Spinal bone screw, non-bioabsorbable

ASTRA-OCT Spine System - M824A3P50501

ASTRA-OCT Dia. 5.0mm Polyaxial Screw, 50mm
SPINECRAFT, LLC
A3P-5050
Not in Commercial Distribution

  • 00193082080104 ()
  • M824A3P50501 ()
A3P-5050

  • 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 - 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
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