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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, 325mm
SPINECRAFT, LLC
A3R-35-325K
Not in Commercial Distribution

  • 00193082082382 ()
  • M824A3R35325K1 ()
A3R-35-325K

  • Bone-screw internal spinal fixation system rod
ASTRA-OCT Dia. 3.5mm Ti Straight Rod, 325mm
SPINECRAFT, LLC
A3R-35-325
Not in Commercial Distribution

  • 00193082081804 ()
  • M824A3R353251 ()
A3R-35-325

  • Bone-screw internal spinal fixation system rod
ASTRA-OCT Dia. 3.5mm CoCr Straight Rod, 300mm
SPINECRAFT, LLC
A3R-35-300K
Not in Commercial Distribution

  • 00193082082375 ()
  • M824A3R35300K1 ()
A3R-35-300K

  • Bone-screw internal spinal fixation system rod
ASTRA-OCT Dia. 3.5mm Ti Straight Rod, 300mm
SPINECRAFT, LLC
A3R-35-300
Not in Commercial Distribution

  • 00193082081798 ()
  • M824A3R353001 ()
A3R-35-300

  • Bone-screw internal spinal fixation system rod
ASTRA-OCT Dia. 3.5mm CoCr Straight Rod, 200mm
SPINECRAFT, LLC
A3R-35-200K
Not in Commercial Distribution

  • 00193082082368 ()
  • M824A3R35200K1 ()
A3R-35-200K

  • Bone-screw internal spinal fixation system rod
ASTRA-OCT Dia. 3.5mm Ti Straight Rod, 200mm
SPINECRAFT, LLC
A3R-35-200
Not in Commercial Distribution

  • 00193082081781 ()
  • M824A3R352001 ()
A3R-35-200

  • Bone-screw internal spinal fixation system rod
ASTRA-OCT Dia. 3.5mm CoCr Straight Rod, 100mm
SPINECRAFT, LLC
A3R-35-100K
Not in Commercial Distribution

  • 00193082082351 ()
  • M824A3R35100K1 ()
A3R-35-100K

  • Bone-screw internal spinal fixation system rod
ASTRA-OCT Dia. 3.5mm Ti Straight Rod, 100mm
SPINECRAFT, LLC
A3R-35-100
Not in Commercial Distribution

  • 00193082081774 ()
  • M824A3R351001 ()
A3R-35-100

  • Bone-screw internal spinal fixation system rod
ASTRA-OCT Dia. 3.5mm CoCr Straight Rod, 90mm
SPINECRAFT, LLC
A3R-35-090K
Not in Commercial Distribution

  • 00193082082344 ()
  • M824A3R35090K1 ()
A3R-35-090K

  • Bone-screw internal spinal fixation system rod
ASTRA-OCT Dia. 3.5mm Ti Straight Rod, 90mm
SPINECRAFT, LLC
A3R-35-090
Not in Commercial Distribution

  • 00193082081767 ()
  • M824A3R350901 ()
A3R-35-090

  • Bone-screw internal spinal fixation system rod
ASTRA-OCT Dia. 3.5mm Ti Straight Rod, 80mm
SPINECRAFT, LLC
A3R-35-080
Not in Commercial Distribution

  • 00193082081750 ()
  • M824A3R350801 ()
A3R-35-080

  • Bone-screw internal spinal fixation system rod
ASTRA-OCT Dia. 3.5mm CoCr Straight Rod, 70mm
SPINECRAFT, LLC
A3R-35-070K
Not in Commercial Distribution

  • 00193082082320 ()
  • M824A3R35070K1 ()
A3R-35-070K

  • Bone-screw internal spinal fixation system rod
ASTRA-OCT Dia. 3.5mm Ti Straight Rod, 60mm
SPINECRAFT, LLC
A3R-35-060
Not in Commercial Distribution

  • 00193082081736 ()
  • M824A3R350601 ()
A3R-35-060

  • Bone-screw internal spinal fixation system rod
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 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, 45mm
SPINECRAFT, LLC
A3P-5045
Not in Commercial Distribution

  • 00193082080098 ()
  • M824A3P50451 ()
A3P-5045

  • Spinal bone screw, non-bioabsorbable
ASTRA-OCT Dia. 5.0mm Polyaxial Screw, 40mm
SPINECRAFT, LLC
A3P-5040
Not in Commercial Distribution

  • 00193082080081 ()
  • M824A3P50401 ()
A3P-5040

  • 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. 5.0mm Polyaxial Screw, 30mm
SPINECRAFT, LLC
A3P-5030
Not in Commercial Distribution

  • 00193082080067 ()
  • M824A3P50301 ()
A3P-5030

  • Spinal bone screw, non-bioabsorbable
ASTRA-OCT Dia. 5.0mm Polyaxial Reduction Screw, 25mm
SPINECRAFT, LLC
A3P-5025R
Not in Commercial Distribution

  • 00193082080845 ()
  • M824A3P5025R1 ()
A3P-5025R

  • Spinal bone screw, non-bioabsorbable
ASTRA-OCT Dia. 5.0mm Polyaxial Screw, 25mm
SPINECRAFT, LLC
A3P-5025
Not in Commercial Distribution

  • 00193082080050 ()
  • M824A3P50251 ()
A3P-5025

  • Spinal bone screw, non-bioabsorbable
ASTRA-OCT Dia. 5.0mm Polyaxial Reduction Screw, 20mm
SPINECRAFT, LLC
A3P-5020R
Not in Commercial Distribution

  • 00193082080838 ()
  • M824A3P5020R1 ()
A3P-5020R

  • Spinal bone screw, non-bioabsorbable
ASTRA-OCT Dia. 5.0mm Polyaxial Screw, 20mm
SPINECRAFT, LLC
A3P-5020
Not in Commercial Distribution

  • 00193082080043 ()
  • M824A3P50201 ()
A3P-5020

  • Spinal bone screw, non-bioabsorbable
ASTRA-OCT Dia. 5.0mm Polyaxial Reduction Screw, 15mm
SPINECRAFT, LLC
A3P-5015R
Not in Commercial Distribution

  • 00193082080821 ()
  • M824A3P5015R1 ()
A3P-5015R

  • Spinal bone screw, non-bioabsorbable
ASTRA-OCT Dia. 5.0mm Polyaxial Screw, 15mm
SPINECRAFT, LLC
A3P-5015
Not in Commercial Distribution

  • 00193082080036 ()
  • M824A3P50151 ()
A3P-5015

  • Spinal bone screw, non-bioabsorbable
ASTRA-OCT Dia. 4.5mm Polyaxial Reduction Screw, 50mm
SPINECRAFT, LLC
A3P-4550R
Not in Commercial Distribution

  • 00193082080814 ()
  • M824A3P4550R1 ()
A3P-4550R

  • Spinal bone screw, non-bioabsorbable
ASTRA-OCT Dia. 4.5mm Polyaxial Screw, 50mm
SPINECRAFT, LLC
A3P-4550
Not in Commercial Distribution

  • 00193082080029 ()
  • M824A3P45501 ()
A3P-4550

  • Spinal bone screw, non-bioabsorbable
ASTRA-OCT Dia. 4.5mm Polyaxial Reduction Screw, 48mm
SPINECRAFT, LLC
A3P-4548R
Not in Commercial Distribution

  • 00193082080807 ()
  • M824A3P4548R1 ()
A3P-4548R

  • Spinal bone screw, non-bioabsorbable
ASTRA-OCT Dia. 4.5mm Polyaxial Screw, 48mm
SPINECRAFT, LLC
A3P-4548
Not in Commercial Distribution

  • 00193082080012 ()
  • M824A3P45481 ()
A3P-4548

  • 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
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