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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 - M824A3R353001

ASTRA-OCT Dia. 3.5mm Ti Straight Rod, 300mm
SPINECRAFT, LLC
A3R-35-300
Not in Commercial Distribution

  • 00193082081798 ()
  • M824A3R353001 ()
A3R-35-300

  • Bone-screw internal spinal fixation system rod

ASTRA-OCT Spine System - M824A3R35200K1

ASTRA-OCT Dia. 3.5mm CoCr Straight Rod, 200mm
SPINECRAFT, LLC
A3R-35-200K
Not in Commercial Distribution

  • 00193082082368 ()
  • M824A3R35200K1 ()
A3R-35-200K

  • Bone-screw internal spinal fixation system rod

ASTRA-OCT Spine System - M824A3R352001

ASTRA-OCT Dia. 3.5mm Ti Straight Rod, 200mm
SPINECRAFT, LLC
A3R-35-200
Not in Commercial Distribution

  • 00193082081781 ()
  • M824A3R352001 ()
A3R-35-200

  • Bone-screw internal spinal fixation system rod

ASTRA-OCT Spine System - M824A3R35100K1

ASTRA-OCT Dia. 3.5mm CoCr Straight Rod, 100mm
SPINECRAFT, LLC
A3R-35-100K
Not in Commercial Distribution

  • 00193082082351 ()
  • M824A3R35100K1 ()
A3R-35-100K

  • Bone-screw internal spinal fixation system rod

ASTRA-OCT Spine System - M824A3R351001

ASTRA-OCT Dia. 3.5mm Ti Straight Rod, 100mm
SPINECRAFT, LLC
A3R-35-100
Not in Commercial Distribution

  • 00193082081774 ()
  • M824A3R351001 ()
A3R-35-100

  • Bone-screw internal spinal fixation system rod

ASTRA-OCT Spine System - M824A3R35090K1

ASTRA-OCT Dia. 3.5mm CoCr Straight Rod, 90mm
SPINECRAFT, LLC
A3R-35-090K
Not in Commercial Distribution

  • 00193082082344 ()
  • M824A3R35090K1 ()
A3R-35-090K

  • Bone-screw internal spinal fixation system rod

ASTRA-OCT Spine System - M824A3R350901

ASTRA-OCT Dia. 3.5mm Ti Straight Rod, 90mm
SPINECRAFT, LLC
A3R-35-090
Not in Commercial Distribution

  • 00193082081767 ()
  • M824A3R350901 ()
A3R-35-090

  • Bone-screw internal spinal fixation system rod

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 - M824A3R350801

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

  • 00193082081750 ()
  • M824A3R350801 ()
A3R-35-080

  • 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 - M824A3R350701

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

  • 00193082081743 ()
  • M824A3R350701 ()
A3R-35-070

  • 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 - M824A3R350601

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

  • 00193082081736 ()
  • M824A3R350601 ()
A3R-35-060

  • Bone-screw internal spinal fixation system rod

ASTRA-OCT Spine System - M824A3R35050K1

ASTRA-OCT Dia. 3.5mm CoCr Straight Rod, 50mm
SPINECRAFT, LLC
A3R-35-050K
Not in Commercial Distribution

  • 00193082082306 ()
  • M824A3R35050K1 ()
A3R-35-050K

  • Bone-screw internal spinal fixation system rod

ASTRA-OCT Spine System - M824A3R350501

ASTRA-OCT Dia. 3.5mm Ti Straight Rod, 50mm
SPINECRAFT, LLC
A3R-35-050
Not in Commercial Distribution

  • 00193082081729 ()
  • M824A3R350501 ()
A3R-35-050

  • Bone-screw internal spinal fixation system rod

ASTRA-OCT Spine System - M824A3R35045K1

ASTRA-OCT Dia. 3.5mm CoCr Straight Rod, 45mm
SPINECRAFT, LLC
A3R-35-045K
Not in Commercial Distribution

  • 00193082082290 ()
  • M824A3R35045K1 ()
A3R-35-045K

  • Bone-screw internal spinal fixation system rod

ASTRA-OCT Spine System - M824A3R350451

ASTRA-OCT Dia. 3.5mm Ti Straight Rod, 45mm
SPINECRAFT, LLC
A3R-35-045
Not in Commercial Distribution

  • 00193082081712 ()
  • M824A3R350451 ()
A3R-35-045

  • Bone-screw internal spinal fixation system rod

ASTRA-OCT Spine System - M824A3R35040K1

ASTRA-OCT Dia. 3.5mm CoCr Straight Rod, 40mm
SPINECRAFT, LLC
A3R-35-040K
Not in Commercial Distribution

  • 00193082082283 ()
  • M824A3R35040K1 ()
A3R-35-040K

  • Bone-screw internal spinal fixation system rod

ASTRA-OCT Spine System - M824A3R350401

ASTRA-OCT Dia. 3.5mm Ti Straight Rod, 40mm
SPINECRAFT, LLC
A3R-35-040
Not in Commercial Distribution

  • 00193082081705 ()
  • M824A3R350401 ()
A3R-35-040

  • Bone-screw internal spinal fixation system rod

ASTRA-OCT Spine System - M824A3R35035K1

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

  • 00193082082276 ()
  • M824A3R35035K1 ()
A3R-35-035K

  • Bone-screw internal spinal fixation system rod

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 - M824A3R35030K1

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

  • 00193082082269 ()
  • M824A3R35030K1 ()
A3R-35-030K

  • 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 - 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 - 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 - 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 - M824A3P5540R1

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

  • 00193082080951 ()
  • M824A3P5540R1 ()
A3P-5540R

  • 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 - M824A3P5535R1

ASTRA-OCT Dia. 5.5mm Polyaxial Reduction Screw, 35mm
SPINECRAFT, LLC
A3P-5535R
Not in Commercial Distribution

  • 00193082080944 ()
  • M824A3P5535R1 ()
A3P-5535R

  • 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 - 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 - 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 - 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 - M824A3P55251

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

  • 00193082080135 ()
  • M824A3P55251 ()
A3P-5525

  • Spinal bone screw, non-bioabsorbable

ASTRA-OCT Spine System - M824A3P5520R1

ASTRA-OCT Dia. 5.5mm Polyaxial Reduction Screw, 20mm
SPINECRAFT, LLC
A3P-5520R
Not in Commercial Distribution

  • 00193082080913 ()
  • M824A3P5520R1 ()
A3P-5520R

  • 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 - M824A3P5515R1

ASTRA-OCT Dia. 5.5mm Polyaxial Reduction Screw, 15mm
SPINECRAFT, LLC
A3P-5515R
Not in Commercial Distribution

  • 00193082080906 ()
  • M824A3P5515R1 ()
A3P-5515R

  • Spinal bone screw, non-bioabsorbable

ASTRA-OCT Spine System - M824A3P55151

ASTRA-OCT Dia. 5.5mm Polyaxial Screw, 15mm
SPINECRAFT, LLC
A3P-5515
Not in Commercial Distribution

  • 00193082080111 ()
  • M824A3P55151 ()
A3P-5515

  • Spinal bone screw, non-bioabsorbable

ASTRA-OCT Spine System - M824A3P5050R1

ASTRA-OCT Dia. 5.0mm Polyaxial Reduction Screw, 50mm
SPINECRAFT, LLC
A3P-5050R
Not in Commercial Distribution

  • 00193082080890 ()
  • M824A3P5050R1 ()
A3P-5050R

  • Spinal bone screw, non-bioabsorbable

ASTRA-OCT Spine System - M824A3P50501

ASTRA-OCT Dia. 5.0mm Polyaxial Screw, 50mm
SPINECRAFT, LLC
A3P-5050
Not in Commercial Distribution

  • 00193082080104 ()
  • M824A3P50501 ()
A3P-5050

  • 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 - 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 - 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
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