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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 - M824A3P35341

ASTRA-OCT Dia. 3.5mm Polyaxial Screw, 34mm
SPINECRAFT, LLC
A3P-3534
Not in Commercial Distribution

  • 00193082079528 ()
  • M824A3P35341 ()
A3P-3534

  • Spinal bone screw, non-bioabsorbable

ASTRA-OCT Spine System - M824A3P3532S1

ASTRA-OCT Dia. 3.5mm Polyaxial Smooth Shank Screw, 32mm
SPINECRAFT, LLC
A3P-3532-S
Not in Commercial Distribution

  • 00193082081057 ()
  • M824A3P3532S1 ()
A3P-3532-S

  • Spinal bone screw, non-bioabsorbable

ASTRA-OCT Spine System - M824A3P3532RS1

ASTRA-OCT Dia. 3.5mm Polyaxial Reduction Smooth Shank Screw, 32mm
SPINECRAFT, LLC
A3P-3532R-S
Not in Commercial Distribution

  • 00193082081392 ()
  • M824A3P3532RS1 ()
A3P-3532R-S

  • Spinal bone screw, non-bioabsorbable

ASTRA-OCT Spine System - M824A3P3532R1

ASTRA-OCT Dia. 3.5mm Polyaxial Reduction Screw, 32mm
SPINECRAFT, LLC
A3P-3532R
Not in Commercial Distribution

  • 00193082080302 ()
  • M824A3P3532R1 ()
A3P-3532R

  • Spinal bone screw, non-bioabsorbable

ASTRA-OCT Spine System - M824A3P35321

ASTRA-OCT Dia. 3.5mm Polyaxial Screw, 32mm
SPINECRAFT, LLC
A3P-3532
Not in Commercial Distribution

  • 00193082079511 ()
  • M824A3P35321 ()
A3P-3532

  • Spinal bone screw, non-bioabsorbable

ASTRA-OCT Spine System - M824A3P3530S1

ASTRA-OCT Dia. 3.5mm Polyaxial Smooth Shank Screw, 30mm
SPINECRAFT, LLC
A3P-3530-S
Not in Commercial Distribution

  • 00193082081040 ()
  • M824A3P3530S1 ()
A3P-3530-S

  • Spinal bone screw, non-bioabsorbable

ASTRA-OCT Spine System - M824A3P3530RS1

ASTRA-OCT Dia. 3.5mm Polyaxial Reduction Smooth Shank Screw, 30mm
SPINECRAFT, LLC
A3P-3530R-S
Not in Commercial Distribution

  • 00193082081385 ()
  • M824A3P3530RS1 ()
A3P-3530R-S

  • Spinal bone screw, non-bioabsorbable

ASTRA-OCT Spine System - M824A3P3530R1

ASTRA-OCT Dia. 3.5mm Polyaxial Reduction Screw, 30mm
SPINECRAFT, LLC
A3P-3530R
Not in Commercial Distribution

  • 00193082080296 ()
  • M824A3P3530R1 ()
A3P-3530R

  • Spinal bone screw, non-bioabsorbable

ASTRA-OCT Spine System - M824A3P3528S1

ASTRA-OCT Dia. 3.5mm Polyaxial Smooth Shank Screw, 28mm
SPINECRAFT, LLC
A3P-3528-S
Not in Commercial Distribution

  • 00193082081033 ()
  • M824A3P3528S1 ()
A3P-3528-S

  • Spinal bone screw, non-bioabsorbable

ASTRA-OCT Spine System - M824A3P35281

ASTRA-OCT Dia. 3.5mm Polyaxial Screw, 28mm
SPINECRAFT, LLC
A3P-3528
Not in Commercial Distribution

  • 00193082079498 ()
  • M824A3P35281 ()
A3P-3528

  • Spinal bone screw, non-bioabsorbable

ASTRA-OCT Spine System - M824A3P3526RS1

ASTRA-OCT Dia. 3.5mm Polyaxial Reduction Smooth Shank Screw, 26mm
SPINECRAFT, LLC
A3P-3526R-S
Not in Commercial Distribution

  • 00193082081361 ()
  • M824A3P3526RS1 ()
A3P-3526R-S

  • Spinal bone screw, non-bioabsorbable

ASTRA-OCT Spine System - M824A3P35261

ASTRA-OCT Dia. 3.5mm Polyaxial Screw, 26mm
SPINECRAFT, LLC
A3P-3526
Not in Commercial Distribution

  • 00193082079481 ()
  • M824A3P35261 ()
A3P-3526

  • Spinal bone screw, non-bioabsorbable

ASTRA-OCT Spine System - M824A3P3524RS1

ASTRA-OCT Dia. 3.5mm Polyaxial Reduction Smooth Shank Screw, 24mm
SPINECRAFT, LLC
A3P-3524R-S
Not in Commercial Distribution

  • 00193082081354 ()
  • M824A3P3524RS1 ()
A3P-3524R-S

  • Spinal bone screw, non-bioabsorbable

ASTRA-OCT Spine System - M824A3P35241

ASTRA-OCT Dia. 3.5mm Polyaxial Screw, 24mm
SPINECRAFT, LLC
A3P-3524
Not in Commercial Distribution

  • 00193082079474 ()
  • M824A3P35241 ()
A3P-3524

  • Spinal bone screw, non-bioabsorbable

ASTRA-OCT Spine System - M824A3P3522RS1

ASTRA-OCT Dia. 3.5mm Polyaxial Reduction Smooth Shank Screw, 22mm
SPINECRAFT, LLC
A3P-3522R-S
Not in Commercial Distribution

  • 00193082081347 ()
  • M824A3P3522RS1 ()
A3P-3522R-S

  • Spinal bone screw, non-bioabsorbable

ASTRA-OCT Spine System - M824A3P35221

ASTRA-OCT Dia. 3.5mm Polyaxial Screw, 22mm
SPINECRAFT, LLC
A3P-3522
Not in Commercial Distribution

  • 00193082079467 ()
  • M824A3P35221 ()
A3P-3522

  • Spinal bone screw, non-bioabsorbable

ASTRA-OCT Spine System - M824A3P3520S1

ASTRA-OCT Dia. 3.5mm Polyaxial Smooth Shank Screw, 20mm
SPINECRAFT, LLC
A3P-3520-S
Not in Commercial Distribution

  • 00193082080999 ()
  • M824A3P3520S1 ()
A3P-3520-S

  • Spinal bone screw, non-bioabsorbable

ASTRA-OCT Spine System - M824A3P3520RS1

ASTRA-OCT Dia. 3.5mm Polyaxial Reduction Smooth Shank Screw, 20mm
SPINECRAFT, LLC
A3P-3520R-S
Not in Commercial Distribution

  • 00193082081330 ()
  • M824A3P3520RS1 ()
A3P-3520R-S

  • Spinal bone screw, non-bioabsorbable

ASTRA-OCT Spine System - M824A3P3520R1

ASTRA-OCT Dia. 3.5mm Polyaxial Reduction Screw, 20mm
SPINECRAFT, LLC
A3P-3520R
Not in Commercial Distribution

  • 00193082080241 ()
  • M824A3P3520R1 ()
A3P-3520R

  • Spinal bone screw, non-bioabsorbable

ASTRA-OCT Spine System - M824A3P35201

ASTRA-OCT Dia. 3.5mm Polyaxial Screw, 20mm
SPINECRAFT, LLC
A3P-3520
Not in Commercial Distribution

  • 00193082079450 ()
  • M824A3P35201 ()
A3P-3520

  • Spinal bone screw, non-bioabsorbable

ASTRA-OCT Spine System - M824A3P3518S1

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

  • 00193082080982 ()
  • M824A3P3518S1 ()
A3P-3518-S

  • Spinal bone screw, non-bioabsorbable

ASTRA-OCT Spine System - M824A3P3518RS1

ASTRA-OCT Dia. 3.5mm Polyaxial Reduction Smooth Shank Screw, 18mm
SPINECRAFT, LLC
A3P-3518R-S
Not in Commercial Distribution

  • 00193082081323 ()
  • M824A3P3518RS1 ()
A3P-3518R-S

  • Spinal bone screw, non-bioabsorbable

ASTRA-OCT Spine System - M824A3P3518R1

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

  • 00193082080234 ()
  • M824A3P3518R1 ()
A3P-3518R

  • Spinal bone screw, non-bioabsorbable

ASTRA-OCT Spine System - M824A3P3516R1

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

  • 00193082080227 ()
  • M824A3P3516R1 ()
A3P-3516R

  • Spinal bone screw, non-bioabsorbable

ASTRA-OCT Spine System - M824A3P35141

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

  • 00193082079429 ()
  • M824A3P35141 ()
A3P-3514

  • Spinal bone screw, non-bioabsorbable

ASTRA-OCT Spine System - M824A3P35121

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

  • 00193082079412 ()
  • M824A3P35121 ()
A3P-3512

  • Spinal bone screw, non-bioabsorbable

ASTRA-OCT Spine System - M824A3P35101

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

  • 00193082079405 ()
  • M824A3P35101 ()
A3P-3510

  • Spinal bone screw, non-bioabsorbable

ASTRA-OCT Spine System - M824A3OS50081

ASTRA-OCT Dia. 5.0mm Occipital Bone Screw, 8mm
SPINECRAFT, LLC
A3OS-5008
Not in Commercial Distribution

  • 00193082083723 ()
  • M824A3OS50081 ()
A3OS-5008

  • Orthopaedic bone screw (non-sliding)

ASTRA-OCT Spine System - M824A3OS45181

ASTRA-OCT Dia. 4.5mm Occipital Bone Screw, 18mm
SPINECRAFT, LLC
A3OS-4518
Not in Commercial Distribution

  • 00193082083709 ()
  • M824A3OS45181 ()
A3OS-4518

  • Orthopaedic bone screw (non-sliding)

ASTRA-OCT Spine System - M824A3OS45141

ASTRA-OCT Dia. 4.5mm Occipital Bone Screw, 14mm
SPINECRAFT, LLC
A3OS-4514
Not in Commercial Distribution

  • 00193082083686 ()
  • M824A3OS45141 ()
A3OS-4514

  • Orthopaedic bone screw (non-sliding)
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