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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 - M824A3R350351

ASTRA-OCT Dia. 3.5mm Ti Straight Rod, 35mm
SPINECRAFT, LLC
A3R-35-035
Not in Commercial Distribution

  • 00193082081699 ()
  • M824A3R350351 ()
A3R-35-035

  • Bone-screw internal spinal fixation system rod

ASTRA-OCT Spine System - M824A3R350301

ASTRA-OCT Dia. 3.5mm Ti Straight Rod, 30mm
SPINECRAFT, LLC
A3R-35-030
Not in Commercial Distribution

  • 00193082081682 ()
  • M824A3R350301 ()
A3R-35-030

  • Bone-screw internal spinal fixation system rod

ASTRA-OCT Spine System - M824A3R35025K1

ASTRA-OCT Dia. 3.5mm CoCr Straight Rod, 25mm
SPINECRAFT, LLC
A3R-35-025K
Not in Commercial Distribution

  • 00193082082252 ()
  • M824A3R35025K1 ()
A3R-35-025K

  • Bone-screw internal spinal fixation system rod

ASTRA-OCT Spine System - M824A3R350251

ASTRA-OCT Dia. 3.5mm Ti Straight Rod, 25mm
SPINECRAFT, LLC
A3R-35-025
Not in Commercial Distribution

  • 00193082081675 ()
  • M824A3R350251 ()
A3R-35-025

  • Bone-screw internal spinal fixation system rod

ASTRA-OCT Spine System - M824A3R35020K1

ASTRA-OCT Dia. 3.5mm CoCr Straight Rod, 20mm
SPINECRAFT, LLC
A3R-35-020K
Not in Commercial Distribution

  • 00193082082245 ()
  • M824A3R35020K1 ()
A3R-35-020K

  • Bone-screw internal spinal fixation system rod

ASTRA-OCT Spine System - M824A3R350201

ASTRA-OCT Dia. 3.5mm Ti Straight Rod, 20mm
SPINECRAFT, LLC
A3R-35-020
Not in Commercial Distribution

  • 00193082081668 ()
  • M824A3R350201 ()
A3R-35-020

  • Bone-screw internal spinal fixation system rod

ASTRA-OCT Spine System - M824A3P5550R1

ASTRA-OCT Dia. 5.5mm Polyaxial Reduction Screw, 50mm
SPINECRAFT, LLC
A3P-5550R
Not in Commercial Distribution

  • 00193082080975 ()
  • M824A3P5550R1 ()
A3P-5550R

  • Spinal bone screw, non-bioabsorbable

ASTRA-OCT Spine System - M824A3P5545R1

ASTRA-OCT Dia. 5.5mm Polyaxial Reduction Screw, 45mm
SPINECRAFT, LLC
A3P-5545R
Not in Commercial Distribution

  • 00193082080968 ()
  • M824A3P5545R1 ()
A3P-5545R

  • Spinal bone screw, non-bioabsorbable

ASTRA-OCT Spine System - M824A3P55401

ASTRA-OCT Dia. 5.5mm Polyaxial Screw, 40mm
SPINECRAFT, LLC
A3P-5540
Not in Commercial Distribution

  • 00193082080166 ()
  • M824A3P55401 ()
A3P-5540

  • Spinal bone screw, non-bioabsorbable

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

ASTRA-OCT Spine System - M824A3P4550R1

ASTRA-OCT Dia. 4.5mm Polyaxial Reduction Screw, 50mm
SPINECRAFT, LLC
A3P-4550R
Not in Commercial Distribution

  • 00193082080814 ()
  • M824A3P4550R1 ()
A3P-4550R

  • Spinal bone screw, non-bioabsorbable

ASTRA-OCT Spine System - M824A3P4528R1

ASTRA-OCT Dia. 4.5mm Polyaxial Reduction Screw, 28mm
SPINECRAFT, LLC
A3P-4528R
Not in Commercial Distribution

  • 00193082080708 ()
  • M824A3P4528R1 ()
A3P-4528R

  • Spinal bone screw, non-bioabsorbable

ASTRA-OCT Spine System - M824A3P45281

ASTRA-OCT Dia. 4.5mm Polyaxial Screw, 28mm
SPINECRAFT, LLC
A3P-4528
Not in Commercial Distribution

  • 00193082079917 ()
  • M824A3P45281 ()
A3P-4528

  • Spinal bone screw, non-bioabsorbable

ASTRA-OCT Spine System - M824A3P45261

ASTRA-OCT Dia. 4.5mm Polyaxial Screw, 26mm
SPINECRAFT, LLC
A3P-4526
Not in Commercial Distribution

  • 00193082079900 ()
  • M824A3P45261 ()
A3P-4526

  • Spinal bone screw, non-bioabsorbable

ASTRA-OCT Spine System - M824A3P4522R1

ASTRA-OCT Dia. 4.5mm Polyaxial Reduction Screw, 22mm
SPINECRAFT, LLC
A3P-4522R
Not in Commercial Distribution

  • 00193082080678 ()
  • M824A3P4522R1 ()
A3P-4522R

  • Spinal bone screw, non-bioabsorbable

ASTRA-OCT Spine System - M824A3P4520R1

ASTRA-OCT Dia. 4.5mm Polyaxial Reduction Screw, 20mm
SPINECRAFT, LLC
A3P-4520R
Not in Commercial Distribution

  • 00193082080661 ()
  • M824A3P4520R1 ()
A3P-4520R

  • Spinal bone screw, non-bioabsorbable

ASTRA-OCT Spine System - M824A3P45181

ASTRA-OCT Dia. 4.5mm Polyaxial Screw, 18mm
SPINECRAFT, LLC
A3P-4518
Not in Commercial Distribution

  • 00193082079863 ()
  • M824A3P45181 ()
A3P-4518

  • Spinal bone screw, non-bioabsorbable

ASTRA-OCT Spine System - M824A3P45161

ASTRA-OCT Dia. 4.5mm Polyaxial Screw, 16mm
SPINECRAFT, LLC
A3P-4516
Not in Commercial Distribution

  • 00193082079856 ()
  • M824A3P45161 ()
A3P-4516

  • Spinal bone screw, non-bioabsorbable

ASTRA-OCT Spine System - M824A3P4512R1

ASTRA-OCT Dia. 4.5mm Polyaxial Reduction Screw, 12mm
SPINECRAFT, LLC
A3P-4512R
Not in Commercial Distribution

  • 00193082080623 ()
  • M824A3P4512R1 ()
A3P-4512R

  • Spinal bone screw, non-bioabsorbable

ASTRA-OCT Spine System - M824A3P4510R1

ASTRA-OCT Dia. 4.5mm Polyaxial Reduction Screw, 10mm
SPINECRAFT, LLC
A3P-4510R
Not in Commercial Distribution

  • 00193082080616 ()
  • M824A3P4510R1 ()
A3P-4510R

  • Spinal bone screw, non-bioabsorbable

ASTRA-OCT Spine System - M824A3P45101

ASTRA-OCT Dia. 4.5mm Polyaxial Screw, 10mm
SPINECRAFT, LLC
A3P-4510
Not in Commercial Distribution

  • 00193082079825 ()
  • M824A3P45101 ()
A3P-4510

  • Spinal bone screw, non-bioabsorbable
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