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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 - M824A3P4018R1

ASTRA-OCT Dia. 4.0mm Polyaxial Reduction Screw, 18mm
SPINECRAFT, LLC
A3P-4018R
Not in Commercial Distribution

  • 00193082080449 ()
  • M824A3P4018R1 ()
A3P-4018R

  • Spinal bone screw, non-bioabsorbable

ASTRA-OCT Spine System - M824A3P40181

ASTRA-OCT Dia. 4.0mm Polyaxial Screw, 18mm
SPINECRAFT, LLC
A3P-4018
Not in Commercial Distribution

  • 00193082079658 ()
  • M824A3P40181 ()
A3P-4018

  • Spinal bone screw, non-bioabsorbable

ASTRA-OCT Spine System - M824A3P4016R1

ASTRA-OCT Dia. 4.0mm Polyaxial Reduction Screw, 16mm
SPINECRAFT, LLC
A3P-4016R
Not in Commercial Distribution

  • 00193082080432 ()
  • M824A3P4016R1 ()
A3P-4016R

  • Spinal bone screw, non-bioabsorbable

ASTRA-OCT Spine System - M824A3P40161

ASTRA-OCT Dia. 4.0mm Polyaxial Screw, 16mm
SPINECRAFT, LLC
A3P-4016
Not in Commercial Distribution

  • 00193082079641 ()
  • M824A3P40161 ()
A3P-4016

  • Spinal bone screw, non-bioabsorbable

ASTRA-OCT Spine System - M824A3P4014R1

ASTRA-OCT Dia. 4.0mm Polyaxial Reduction Screw, 14mm
SPINECRAFT, LLC
A3P-4014R
Not in Commercial Distribution

  • 00193082080425 ()
  • M824A3P4014R1 ()
A3P-4014R

  • Spinal bone screw, non-bioabsorbable

ASTRA-OCT Spine System - M824A3P40141

ASTRA-OCT Dia. 4.0mm Polyaxial Screw, 14mm
SPINECRAFT, LLC
A3P-4014
Not in Commercial Distribution

  • 00193082079634 ()
  • M824A3P40141 ()
A3P-4014

  • Spinal bone screw, non-bioabsorbable

ASTRA-OCT Spine System - M824A3P4012R1

ASTRA-OCT Dia. 4.0mm Polyaxial Reduction Screw, 12mm
SPINECRAFT, LLC
A3P-4012R
Not in Commercial Distribution

  • 00193082080418 ()
  • M824A3P4012R1 ()
A3P-4012R

  • Spinal bone screw, non-bioabsorbable

ASTRA-OCT Spine System - M824A3P40121

ASTRA-OCT Dia. 4.0mm Polyaxial Screw, 12mm
SPINECRAFT, LLC
A3P-4012
Not in Commercial Distribution

  • 00193082079627 ()
  • M824A3P40121 ()
A3P-4012

  • Spinal bone screw, non-bioabsorbable

ASTRA-OCT Spine System - M824A3P4010R1

ASTRA-OCT Dia. 4.0mm Polyaxial Reduction Screw, 10mm
SPINECRAFT, LLC
A3P-4010R
Not in Commercial Distribution

  • 00193082080401 ()
  • M824A3P4010R1 ()
A3P-4010R

  • Spinal bone screw, non-bioabsorbable

ASTRA-OCT Spine System - M824A3P40101

ASTRA-OCT Dia. 4.0mm Polyaxial Screw, 10mm
SPINECRAFT, LLC
A3P-4010
Not in Commercial Distribution

  • 00193082079610 ()
  • M824A3P40101 ()
A3P-4010

  • Spinal bone screw, non-bioabsorbable

ASTRA-OCT Spine System - M824A3P3550S1

ASTRA-OCT Dia. 3.5mm Polyaxial Smooth Shank Screw, 50mm
SPINECRAFT, LLC
A3P-3550-S
Not in Commercial Distribution

  • 00193082081149 ()
  • M824A3P3550S1 ()
A3P-3550-S

  • Spinal bone screw, non-bioabsorbable

ASTRA-OCT Spine System - M824A3P3550RS1

ASTRA-OCT Dia. 3.5mm Polyaxial Reduction Smooth Shank Screw, 50mm
SPINECRAFT, LLC
A3P-3550R-S
Not in Commercial Distribution

  • 00193082081484 ()
  • M824A3P3550RS1 ()
A3P-3550R-S

  • Spinal bone screw, non-bioabsorbable

ASTRA-OCT Spine System - M824A3P3550R1

ASTRA-OCT Dia. 3.5mm Polyaxial Reduction Screw, 50mm
SPINECRAFT, LLC
A3P-3550R
Not in Commercial Distribution

  • 00193082080395 ()
  • M824A3P3550R1 ()
A3P-3550R

  • Spinal bone screw, non-bioabsorbable

ASTRA-OCT Spine System - M824A3P35501

ASTRA-OCT Dia. 3.5mm Polyaxial Screw, 50mm
SPINECRAFT, LLC
A3P-3550
Not in Commercial Distribution

  • 00193082079603 ()
  • M824A3P35501 ()
A3P-3550

  • Spinal bone screw, non-bioabsorbable

ASTRA-OCT Spine System - M824A3P3548S1

ASTRA-OCT Dia. 3.5mm Polyaxial Smooth Shank Screw, 48mm
SPINECRAFT, LLC
A3P-3548-S
Not in Commercial Distribution

  • 00193082081132 ()
  • M824A3P3548S1 ()
A3P-3548-S

  • Spinal bone screw, non-bioabsorbable

ASTRA-OCT Spine System - M824A3P3548RS1

ASTRA-OCT Dia. 3.5mm Polyaxial Reduction Smooth Shank Screw, 48mm
SPINECRAFT, LLC
A3P-3548R-S
Not in Commercial Distribution

  • 00193082081477 ()
  • M824A3P3548RS1 ()
A3P-3548R-S

  • Spinal bone screw, non-bioabsorbable

ASTRA-OCT Spine System - M824A3P3548R1

ASTRA-OCT Dia. 3.5mm Polyaxial Reduction Screw, 48mm
SPINECRAFT, LLC
A3P-3548R
Not in Commercial Distribution

  • 00193082080388 ()
  • M824A3P3548R1 ()
A3P-3548R

  • Spinal bone screw, non-bioabsorbable

ASTRA-OCT Spine System - M824A3P35481

ASTRA-OCT Dia. 3.5mm Polyaxial Screw, 48mm
SPINECRAFT, LLC
A3P-3548
Not in Commercial Distribution

  • 00193082079597 ()
  • M824A3P35481 ()
A3P-3548

  • Spinal bone screw, non-bioabsorbable

ASTRA-OCT Spine System - M824A3P3546S1

ASTRA-OCT Dia. 3.5mm Polyaxial Smooth Shank Screw, 46mm
SPINECRAFT, LLC
A3P-3546-S
Not in Commercial Distribution

  • 00193082081125 ()
  • M824A3P3546S1 ()
A3P-3546-S

  • Spinal bone screw, non-bioabsorbable

ASTRA-OCT Spine System - M824A3ZR409325K1

ASTRA-OCT Dia. 4mm CoCr Z-Rod, 9mm Offset, 325mm
SPINECRAFT, LLC
A3ZR-409-325K
Not in Commercial Distribution

  • 00193082083594 ()
  • M824A3ZR409325K1 ()
A3ZR-409-325K

  • Bone-screw internal spinal fixation system rod

ASTRA-OCT Spine System - M824A3ZR4093251

ASTRA-OCT Dia. 4mm Ti Z-Rod, 9mm Offset, 325mm
SPINECRAFT, LLC
A3ZR-409-325
Not in Commercial Distribution

  • 00193082083471 ()
  • M824A3ZR4093251 ()
A3ZR-409-325

  • Bone-screw internal spinal fixation system rod

ASTRA-OCT Spine System - M824A3ZR409200K1

ASTRA-OCT Dia. 4mm CoCr Z-Rod, 9mm Offset, 200mm
SPINECRAFT, LLC
A3ZR-409-200K
Not in Commercial Distribution

  • 00193082083587 ()
  • M824A3ZR409200K1 ()
A3ZR-409-200K

  • Bone-screw internal spinal fixation system rod

ASTRA-OCT Spine System - M824A3ZR4092001

ASTRA-OCT Dia. 4mm Ti Z-Rod, 9mm Offset, 200mm
SPINECRAFT, LLC
A3ZR-409-200
Not in Commercial Distribution

  • 00193082083464 ()
  • M824A3ZR4092001 ()
A3ZR-409-200

  • Bone-screw internal spinal fixation system rod

ASTRA-OCT Spine System - M824A3ZR409100K1

ASTRA-OCT Dia. 4mm CoCr Z-Rod, 9mm Offset, 100mm
SPINECRAFT, LLC
A3ZR-409-100K
Not in Commercial Distribution

  • 00193082083570 ()
  • M824A3ZR409100K1 ()
A3ZR-409-100K

  • Bone-screw internal spinal fixation system rod

ASTRA-OCT Spine System - M824A3ZR4091001

ASTRA-OCT Dia. 4mm Ti Z-Rod, 9mm Offset, 100mm
SPINECRAFT, LLC
A3ZR-409-100
Not in Commercial Distribution

  • 00193082083457 ()
  • M824A3ZR4091001 ()
A3ZR-409-100

  • Bone-screw internal spinal fixation system rod

ASTRA-OCT Spine System - M824A3ZR407325K1

ASTRA-OCT Dia. 4mm CoCr Z-Rod, 7mm Offset, 325mm
SPINECRAFT, LLC
A3ZR-407-325K
Not in Commercial Distribution

  • 00193082083563 ()
  • M824A3ZR407325K1 ()
A3ZR-407-325K

  • Bone-screw internal spinal fixation system rod

ASTRA-OCT Spine System - M824A3ZR4073251

ASTRA-OCT Dia. 4mm Ti Z-Rod, 7mm Offset, 325mm
SPINECRAFT, LLC
A3ZR-407-325
Not in Commercial Distribution

  • 00193082083440 ()
  • M824A3ZR4073251 ()
A3ZR-407-325

  • Bone-screw internal spinal fixation system rod

ASTRA-OCT Spine System - M824A3ZR407200K1

ASTRA-OCT Dia. 4mm CoCr Z-Rod, 7mm Offset, 200mm
SPINECRAFT, LLC
A3ZR-407-200K
Not in Commercial Distribution

  • 00193082083556 ()
  • M824A3ZR407200K1 ()
A3ZR-407-200K

  • Bone-screw internal spinal fixation system rod

ASTRA-OCT Spine System - M824A3ZR4072001

ASTRA-OCT Dia. 4mm Ti Z-Rod, 7mm Offset, 200mm
SPINECRAFT, LLC
A3ZR-407-200
Not in Commercial Distribution

  • 00193082083433 ()
  • M824A3ZR4072001 ()
A3ZR-407-200

  • Bone-screw internal spinal fixation system rod

ASTRA-OCT Spine System - M824A3ZR407100K1

ASTRA-OCT Dia. 4mm CoCr Z-Rod, 7mm Offset, 100mm
SPINECRAFT, LLC
A3ZR-407-100K
Not in Commercial Distribution

  • 00193082083549 ()
  • M824A3ZR407100K1 ()
A3ZR-407-100K

  • Bone-screw internal spinal fixation system rod
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