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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 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 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 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 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 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 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 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 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 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 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
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