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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 - M824A3P35181

ASTRA-OCT Dia. 3.5mm Polyaxial Screw, 18mm
SPINECRAFT, LLC
A3P-3518
Not in Commercial Distribution

  • 00193082079443 ()
  • M824A3P35181 ()
A3P-3518

  • Spinal bone screw, non-bioabsorbable

ASTRA-OCT Spine System - M824A3P35161

ASTRA-OCT Dia. 3.5mm Polyaxial Screw, 16mm
SPINECRAFT, LLC
A3P-3516
Not in Commercial Distribution

  • 00193082079436 ()
  • M824A3P35161 ()
A3P-3516

  • Spinal bone screw, non-bioabsorbable

ASTRA-OCT Spine System - M824A3P3514R1

ASTRA-OCT Dia. 3.5mm Polyaxial Reduction Screw, 14mm
SPINECRAFT, LLC
A3P-3514R
Not in Commercial Distribution

  • 00193082080210 ()
  • M824A3P3514R1 ()
A3P-3514R

  • Spinal bone screw, non-bioabsorbable

ASTRA-OCT Spine System - M824A3P3512R1

ASTRA-OCT Dia. 3.5mm Polyaxial Reduction Screw, 12mm
SPINECRAFT, LLC
A3P-3512R
Not in Commercial Distribution

  • 00193082080203 ()
  • M824A3P3512R1 ()
A3P-3512R

  • Spinal bone screw, non-bioabsorbable

ASTRA-OCT Spine System - M824A3P3510R1

ASTRA-OCT Dia. 3.5mm Polyaxial Reduction Screw, 10mm
SPINECRAFT, LLC
A3P-3510R
Not in Commercial Distribution

  • 00193082080197 ()
  • M824A3P3510R1 ()
A3P-3510R

  • Spinal bone screw, non-bioabsorbable

ASTRA-OCT Spine System - M824A3OS50181

ASTRA-OCT Dia. 5.0mm Occipital Bone Screw, 18mm
SPINECRAFT, LLC
A3OS-5018
Not in Commercial Distribution

  • 00193082083778 ()
  • M824A3OS50181 ()
A3OS-5018

  • Orthopaedic bone screw (non-sliding)

ASTRA-OCT Spine System - M824A3OS50161

ASTRA-OCT Dia. 5.0mm Occipital Bone Screw, 16mm
SPINECRAFT, LLC
A3OS-5016
Not in Commercial Distribution

  • 00193082083761 ()
  • M824A3OS50161 ()
A3OS-5016

  • Orthopaedic bone screw (non-sliding)

ASTRA-OCT Spine System - M824A3OS50141

ASTRA-OCT Dia. 5.0mm Occipital Bone Screw, 14mm
SPINECRAFT, LLC
A3OS-5014
Not in Commercial Distribution

  • 00193082083754 ()
  • M824A3OS50141 ()
A3OS-5014

  • Orthopaedic bone screw (non-sliding)

ASTRA-OCT Spine System - M824A3OS50121

ASTRA-OCT Dia. 5.0mm Occipital Bone Screw, 12mm
SPINECRAFT, LLC
A3OS-5012
Not in Commercial Distribution

  • 00193082083747 ()
  • M824A3OS50121 ()
A3OS-5012

  • Orthopaedic bone screw (non-sliding)

ASTRA-OCT Spine System - M824A3OS50101

ASTRA-OCT Dia. 5.0mm Occipital Bone Screw, 10mm
SPINECRAFT, LLC
A3OS-5010
Not in Commercial Distribution

  • 00193082083730 ()
  • M824A3OS50101 ()
A3OS-5010

  • Orthopaedic bone screw (non-sliding)
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