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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 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 Cross Connector Nut
SPINECRAFT, LLC
A3S-XN
Not in Commercial Distribution

  • 00193082083204 ()
  • M824A3SXN1 ()
A3S-XN

  • Spinal bone set screw
ASTRA-OCT T15 Set Screw, Flat
SPINECRAFT, LLC
A3S-T15F
Not in Commercial Distribution

  • 00193082083198 ()
  • M824A3ST15F1 ()
A3S-T15F

  • Spinal bone set screw
ASTRA-OCT T15 Set Screw
SPINECRAFT, LLC
A3S-T15
Not in Commercial Distribution

  • 00193082083174 ()
  • M824A3ST151 ()
A3S-T15

  • 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 Ti Transition Rod, Dia. 4mm to Dia. 5.5mm, 500mm
SPINECRAFT, LLC
A3R-T45-500
Not in Commercial Distribution

  • 00193082082146 ()
  • M824A3RT455001 ()
A3R-T45-500

  • 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 Ti Transition Rod, Dia. 4mm to Dia. 5.5mm, 325mm
SPINECRAFT, LLC
A3R-T45-325
Not in Commercial Distribution

  • 00193082082139 ()
  • M824A3RT453251 ()
A3R-T45-325

  • 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 Ti Transition Rod, Dia. 4mm to Dia. 4.5mm, 500mm
SPINECRAFT, LLC
A3R-T44-500
Not in Commercial Distribution

  • 00193082082122 ()
  • M824A3RT445001 ()
A3R-T44-500

  • Bone-screw internal spinal fixation system rod
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