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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 Screw, 32mm
SPINECRAFT, LLC
A3P-3532
Not in Commercial Distribution

  • 00193082079511 ()
  • M824A3P35321 ()
A3P-3532

  • Spinal bone screw, non-bioabsorbable
ASTRA-OCT Dia. 3.5mm Polyaxial Smooth Shank Screw, 30mm
SPINECRAFT, LLC
A3P-3530-S
Not in Commercial Distribution

  • 00193082081040 ()
  • M824A3P3530S1 ()
A3P-3530-S

  • Spinal bone screw, non-bioabsorbable
ASTRA-OCT Dia. 3.5mm Polyaxial Reduction Smooth Shank Screw, 30mm
SPINECRAFT, LLC
A3P-3530R-S
Not in Commercial Distribution

  • 00193082081385 ()
  • M824A3P3530RS1 ()
A3P-3530R-S

  • Spinal bone screw, non-bioabsorbable
ASTRA-OCT Dia. 3.5mm Polyaxial Reduction Smooth Shank Screw, 28mm
SPINECRAFT, LLC
A3P-3528R-S
Not in Commercial Distribution

  • 00193082081378 ()
  • M824A3P3528RS1 ()
A3P-3528R-S

  • Spinal bone screw, non-bioabsorbable
ASTRA-OCT Dia. 3.5mm Polyaxial Reduction Screw, 22mm
SPINECRAFT, LLC
A3P-3522R
Not in Commercial Distribution

  • 00193082080258 ()
  • M824A3P3522R1 ()
A3P-3522R

  • Spinal bone screw, non-bioabsorbable
ASTRA-OCT Dia. 3.5mm Polyaxial Screw, 12mm
SPINECRAFT, LLC
A3P-3512
Not in Commercial Distribution

  • 00193082079412 ()
  • M824A3P35121 ()
A3P-3512

  • Spinal bone screw, non-bioabsorbable
ASTRA-OCT Dia. 3.5mm Polyaxial Reduction Screw, 10mm
SPINECRAFT, LLC
A3P-3510R
Not in Commercial Distribution

  • 00193082080197 ()
  • M824A3P3510R1 ()
A3P-3510R

  • Spinal bone screw, non-bioabsorbable
ASTRA-OCT Dia. 5.0mm Occipital Bone Screw, 10mm
SPINECRAFT, LLC
A3OS-5010
Not in Commercial Distribution

  • 00193082083730 ()
  • M824A3OS50101 ()
A3OS-5010

  • Orthopaedic bone screw (non-sliding)
ASTRA-OCT Dia. 4mm CoCr Occipital Rod, 200mm x 90deg (90deg)
SPINECRAFT, LLC
A3OR-40-9020K
Not in Commercial Distribution

  • 00193082082795 ()
  • M824A3OR409020K1 ()
A3OR-40-9020K

  • Bone-screw internal spinal fixation system rod
ASTRA-OCT Dia. 4mm Ti Occipital Rod, 200mm x 90deg (90deg)
SPINECRAFT, LLC
A3OR-40-9020
Not in Commercial Distribution

  • 00193082082214 ()
  • M824A3OR4090201 ()
A3OR-40-9020

  • Bone-screw internal spinal fixation system rod
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