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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. 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, 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 Screw, 35mm
SPINECRAFT, LLC
A3P-5035
Not in Commercial Distribution

  • 00193082080074 ()
  • M824A3P50351 ()
A3P-5035

  • Spinal bone screw, non-bioabsorbable
ASTRA-OCT Dia. 4.5mm Polyaxial Reduction Screw, 46mm
SPINECRAFT, LLC
A3P-4546R
Not in Commercial Distribution

  • 00193082080791 ()
  • M824A3P4546R1 ()
A3P-4546R

  • Spinal bone screw, non-bioabsorbable
ASTRA-OCT Dia. 4.5mm Polyaxial Screw, 46mm
SPINECRAFT, LLC
A3P-4546
Not in Commercial Distribution

  • 00193082080005 ()
  • M824A3P45461 ()
A3P-4546

  • Spinal bone screw, non-bioabsorbable
ASTRA-OCT Dia. 4.5mm Polyaxial Reduction Screw, 44mm
SPINECRAFT, LLC
A3P-4544R
Not in Commercial Distribution

  • 00193082080784 ()
  • M824A3P4544R1 ()
A3P-4544R

  • Spinal bone screw, non-bioabsorbable
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