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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 Spine System - M824A3TC45151

ASTRA-OCT Tandem Connector, 15mm, fitting Dia. 4.5/Dia. 5.0mm (2 screw)
SPINECRAFT, LLC
A3T-C45-15
Not in Commercial Distribution

  • 00193082083129 ()
  • M824A3TC45151 ()
A3T-C45-15

  • Bone-screw internal spinal fixation system connector

ASTRA-OCT Spine System - M824A3TC35281

ASTRA-OCT Tandem Connector, 28mm, fitting Dia. 3.5/Dia. 4.0mm (4 screw)
SPINECRAFT, LLC
A3T-C35-28
Not in Commercial Distribution

  • 00193082083143 ()
  • M824A3TC35281 ()
A3T-C35-28

  • Bone-screw internal spinal fixation system connector

ASTRA-OCT Spine System - M824A3SXT151

ASTRA-OCT Screw-to-Screw Cross Connector T15 Set Screw
SPINECRAFT, LLC
A3S-XT15
Not in Commercial Distribution

  • 00193082083211 ()
  • M824A3SXT151 ()
A3S-XT15

  • Spinal bone set screw

ASTRA-OCT Spine System - M824A3ST15F1

ASTRA-OCT T15 Set Screw, Flat
SPINECRAFT, LLC
A3S-T15F
Not in Commercial Distribution

  • 00193082083198 ()
  • M824A3ST15F1 ()
A3S-T15F

  • Spinal bone set screw

ASTRA-OCT Spine System - M824A3RT45500K1

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 Spine System - M824A3RT45325K1

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 Spine System - M824A3RT44500K1

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 Spine System - M824A3RT44325K1

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 Spine System - M824A3RT443251

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 Spine System - M824A3RT35500K1

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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