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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 Z-Rod, 7mm Offset, 325mm
SPINECRAFT, LLC
A3ZR-357-325K
Not in Commercial Distribution

  • 00193082083501 ()
  • M824A3ZR357325K1 ()
A3ZR-357-325K

  • Bone-screw internal spinal fixation system rod
ASTRA-OCT Dia. 3.5mm Ti Z-Rod, 7mm Offset, 200mm
SPINECRAFT, LLC
A3ZR-357-200
Not in Commercial Distribution

  • 00193082083372 ()
  • M824A3ZR3572001 ()
A3ZR-357-200

  • Bone-screw internal spinal fixation system rod
ASTRA-OCT Dia. 3.5mm Ti Z-Rod, 7mm Offset, 100mm
SPINECRAFT, LLC
A3ZR-357-100
Not in Commercial Distribution

  • 00193082083365 ()
  • M824A3ZR3571001 ()
A3ZR-357-100

  • Bone-screw internal spinal fixation system rod
ASTRA-OCT Tandem Connector, 15mm, fitting Dia. 3.5/Dia. 4.0mm (2 screw)
SPINECRAFT, LLC
A3T-C35-15
Not in Commercial Distribution

  • 00193082083112 ()
  • M824A3TC35151 ()
A3T-C35-15

  • Bone-screw internal spinal fixation system connector
ASTRA-OCT T15 Set Screw, Coned
SPINECRAFT, LLC
A3S-T15C
Not in Commercial Distribution

  • 00193082083181 ()
  • M824A3ST15C1 ()
A3S-T15C

  • Spinal bone set screw
ASTRA-OCT Dia. 4mm CoCr Transition Rod, Dia. 4mm to Dia. 5.5mm, 500mm
SPINECRAFT, LLC
A3R-T45-500K
Not in Commercial Distribution

  • 00193082082726 ()
  • M824A3RT45500K1 ()
A3R-T45-500K

  • Bone-screw internal spinal fixation system rod
ASTRA-OCT Dia. 4mm CoCr Transition Rod, Dia. 4mm to Dia. 5.5mm, 325mm
SPINECRAFT, LLC
A3R-T45-325K
Not in Commercial Distribution

  • 00193082082719 ()
  • M824A3RT45325K1 ()
A3R-T45-325K

  • Bone-screw internal spinal fixation system rod
ASTRA-OCT Dia. 4mm CoCr Transition Rod, Dia. 4mm to Dia. 4.5mm, 500mm
SPINECRAFT, LLC
A3R-T44-500K
Not in Commercial Distribution

  • 00193082082702 ()
  • M824A3RT44500K1 ()
A3R-T44-500K

  • 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. 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
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