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

  • 00193082080098 ()
  • M824A3P50451 ()
A3P-5045

  • Spinal bone screw, non-bioabsorbable
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