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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 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 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 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 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
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