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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 - M824A3R35080K1

ASTRA-OCT Dia. 3.5mm CoCr Straight Rod, 80mm
SPINECRAFT, LLC
A3R-35-080K
Not in Commercial Distribution

  • 00193082082337 ()
  • M824A3R35080K1 ()
A3R-35-080K

  • Bone-screw internal spinal fixation system rod

ASTRA-OCT Spine System - M824A3R35070K1

ASTRA-OCT Dia. 3.5mm CoCr Straight Rod, 70mm
SPINECRAFT, LLC
A3R-35-070K
Not in Commercial Distribution

  • 00193082082320 ()
  • M824A3R35070K1 ()
A3R-35-070K

  • Bone-screw internal spinal fixation system rod

ASTRA-OCT Spine System - M824A3R35060K1

ASTRA-OCT Dia. 3.5mm CoCr Straight Rod, 60mm
SPINECRAFT, LLC
A3R-35-060K
Not in Commercial Distribution

  • 00193082082313 ()
  • M824A3R35060K1 ()
A3R-35-060K

  • 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 - M824A3P55501

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

  • 00193082080180 ()
  • M824A3P55501 ()
A3P-5550

  • Spinal bone screw, non-bioabsorbable

ASTRA-OCT Spine System - M824A3P55451

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

  • 00193082080173 ()
  • M824A3P55451 ()
A3P-5545

  • 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 - M824A3P5530R1

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

  • 00193082080937 ()
  • M824A3P5530R1 ()
A3P-5530R

  • Spinal bone screw, non-bioabsorbable

ASTRA-OCT Spine System - M824A3P5525R1

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

  • 00193082080920 ()
  • M824A3P5525R1 ()
A3P-5525R

  • 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 - M824A3P5045R1

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

  • 00193082080883 ()
  • M824A3P5045R1 ()
A3P-5045R

  • 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 - M824A3P5035R1

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

  • 00193082080869 ()
  • M824A3P5035R1 ()
A3P-5035R

  • 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 - M824A3P5030R1

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

  • 00193082080852 ()
  • M824A3P5030R1 ()
A3P-5030R

  • 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 - M824A3P5020R1

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

  • 00193082080838 ()
  • M824A3P5020R1 ()
A3P-5020R

  • 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 - M824A3P50151

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

  • 00193082080036 ()
  • M824A3P50151 ()
A3P-5015

  • 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 - M824A3P4548R1

ASTRA-OCT Dia. 4.5mm Polyaxial Reduction Screw, 48mm
SPINECRAFT, LLC
A3P-4548R
Not in Commercial Distribution

  • 00193082080807 ()
  • M824A3P4548R1 ()
A3P-4548R

  • Spinal bone screw, non-bioabsorbable

ASTRA-OCT Spine System - M824A3P4546R1

ASTRA-OCT Dia. 4.5mm Polyaxial Reduction Screw, 46mm
SPINECRAFT, LLC
A3P-4546R
Not in Commercial Distribution

  • 00193082080791 ()
  • M824A3P4546R1 ()
A3P-4546R

  • Spinal bone screw, non-bioabsorbable

ASTRA-OCT Spine System - M824A3P4544R1

ASTRA-OCT Dia. 4.5mm Polyaxial Reduction Screw, 44mm
SPINECRAFT, LLC
A3P-4544R
Not in Commercial Distribution

  • 00193082080784 ()
  • M824A3P4544R1 ()
A3P-4544R

  • Spinal bone screw, non-bioabsorbable

ASTRA-OCT Spine System - M824A3P45421

ASTRA-OCT Dia. 4.5mm Polyaxial Screw, 42mm
SPINECRAFT, LLC
A3P-4542
Not in Commercial Distribution

  • 00193082079986 ()
  • M824A3P45421 ()
A3P-4542

  • Spinal bone screw, non-bioabsorbable

ASTRA-OCT Spine System - M824A3P4540R1

ASTRA-OCT Dia. 4.5mm Polyaxial Reduction Screw, 40mm
SPINECRAFT, LLC
A3P-4540R
Not in Commercial Distribution

  • 00193082080760 ()
  • M824A3P4540R1 ()
A3P-4540R

  • Spinal bone screw, non-bioabsorbable

ASTRA-OCT Spine System - M824A3P45401

ASTRA-OCT Dia. 4.5mm Polyaxial Screw, 40mm
SPINECRAFT, LLC
A3P-4540
Not in Commercial Distribution

  • 00193082079979 ()
  • M824A3P45401 ()
A3P-4540

  • Spinal bone screw, non-bioabsorbable
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