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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. 4mm CoCr Z-Rod, 7mm Offset, 100mm
SPINECRAFT, LLC
A3ZR-407-100K
Not in Commercial Distribution

  • 00193082083549 ()
  • M824A3ZR407100K1 ()
A3ZR-407-100K

  • Bone-screw internal spinal fixation system rod
ASTRA-OCT Dia. 4mm Ti Z-Rod, 7mm Offset, 100mm
SPINECRAFT, LLC
A3ZR-407-100
Not in Commercial Distribution

  • 00193082083426 ()
  • M824A3ZR4071001 ()
A3ZR-407-100

  • Bone-screw internal spinal fixation system rod
ASTRA-OCT Dia. 3.5mm CoCr Z-Rod, 9mm Offset, 325mm
SPINECRAFT, LLC
A3ZR-359-325K
Not in Commercial Distribution

  • 00193082083532 ()
  • M824A3ZR359325K1 ()
A3ZR-359-325K

  • Bone-screw internal spinal fixation system rod
ASTRA-OCT Dia. 4mm CoCr Transition Rod, Dia. 4mm to Dia. 4.5mm, 325mm
SPINECRAFT, LLC
A3R-T44-325K
Not in Commercial Distribution

  • 00193082082696 ()
  • M824A3RT44325K1 ()
A3R-T44-325K

  • Bone-screw internal spinal fixation system rod
ASTRA-OCT Dia. 4mm Ti Rod, Dia. 4mm to Dia. 4.5mm, 325mm
SPINECRAFT, LLC
A3R-T44-325
Not in Commercial Distribution

  • 00193082082115 ()
  • M824A3RT443251 ()
A3R-T44-325

  • Bone-screw internal spinal fixation system rod
ASTRA-OCT Dia. 3.5mm CoCr Transition Rod, Dia. 3.5mm to Dia. 5.5mm, 500mm
SPINECRAFT, LLC
A3R-T35-500K
Not in Commercial Distribution

  • 00193082082436 ()
  • M824A3RT35500K1 ()
A3R-T35-500K

  • Bone-screw internal spinal fixation system rod
ASTRA-OCT Dia. 3.5mm Ti Transition Rod, Dia. 3.5mm to Dia. 5.5mm, 500mm
SPINECRAFT, LLC
A3R-T35-500
Not in Commercial Distribution

  • 00193082081859 ()
  • M824A3RT355001 ()
A3R-T35-500

  • Bone-screw internal spinal fixation system rod
ASTRA-OCT Dia. 3.5mm CoCr Transition Rod, Dia. 3.5mm to Dia. 5.5mm, 325mm
SPINECRAFT, LLC
A3R-T35-325K
Not in Commercial Distribution

  • 00193082082429 ()
  • M824A3RT35325K1 ()
A3R-T35-325K

  • Bone-screw internal spinal fixation system rod
ASTRA-OCT Dia. 3.5mm Ti Transition Rod, Dia. 3.5mm to Dia. 5.5mm, 325mm
SPINECRAFT, LLC
A3R-T35-325
Not in Commercial Distribution

  • 00193082081842 ()
  • M824A3RT353251 ()
A3R-T35-325

  • Bone-screw internal spinal fixation system rod
ASTRA-OCT Dia. 3.5mm CoCr Transition Rod, Dia. 3.5mm to Dia. 4.5mm, 500mm
SPINECRAFT, LLC
A3R-T34-500K
Not in Commercial Distribution

  • 00193082082412 ()
  • M824A3RT34500K1 ()
A3R-T34-500K

  • Bone-screw internal spinal fixation system rod
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