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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 - M824A3ZR4071001

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 Spine System - M824A3ZR3593251

ASTRA-OCT Dia. 3.5mm Ti Z-Rod, 9mm Offset, 325mm
SPINECRAFT, LLC
A3ZR-359-325
Not in Commercial Distribution

  • 00193082083419 ()
  • M824A3ZR3593251 ()
A3ZR-359-325

  • Bone-screw internal spinal fixation system rod

ASTRA-OCT Spine System - M824A3ZR3592001

ASTRA-OCT Dia. 3.5mm Ti Z-Rod, 9mm Offset, 200mm
SPINECRAFT, LLC
A3ZR-359-200
Not in Commercial Distribution

  • 00193082083402 ()
  • M824A3ZR3592001 ()
A3ZR-359-200

  • Bone-screw internal spinal fixation system rod

ASTRA-OCT Spine System - M824A3ZR3591001

ASTRA-OCT Dia. 3.5mm Ti Z-Rod, 9mm Offset, 100mm
SPINECRAFT, LLC
A3ZR-359-100
Not in Commercial Distribution

  • 00193082083396 ()
  • M824A3ZR3591001 ()
A3ZR-359-100

  • Bone-screw internal spinal fixation system rod

ASTRA-OCT Spine System - M824A3ZR3573251

ASTRA-OCT Dia. 3.5mm Ti Z-Rod, 7mm Offset, 325mm
SPINECRAFT, LLC
A3ZR-357-325
Not in Commercial Distribution

  • 00193082083389 ()
  • M824A3ZR3573251 ()
A3ZR-357-325

  • Bone-screw internal spinal fixation system rod

ASTRA-OCT Spine System - M824A3ZR3572001

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 Spine System - M824A3XS491

ASTRA-OCT Screw-to-Screw Cross Connector, 49mm
SPINECRAFT, LLC
A3X-S49
Not in Commercial Distribution

  • 00193082083044 ()
  • M824A3XS491 ()
A3X-S49

  • Bone-screw internal spinal fixation system connector

ASTRA-OCT Spine System - M824A3XS411

ASTRA-OCT Screw-to-Screw Cross Connector, 41mm
SPINECRAFT, LLC
A3X-S41
Not in Commercial Distribution

  • 00193082083020 ()
  • M824A3XS411 ()
A3X-S41

  • Bone-screw internal spinal fixation system connector

ASTRA-OCT Spine System - M824A3XR39491

ASTRA-OCT Adjustable Rod-to-Rod Cross Connector, 39-49mm
SPINECRAFT, LLC
A3X-R3949
Not in Commercial Distribution

  • 00193082082993 ()
  • M824A3XR39491 ()
A3X-R3949

  • Bone-screw internal spinal fixation system connector

ASTRA-OCT Spine System - M824A3XR35401

ASTRA-OCT Adjustable Rod-to-Rod Cross Connector, 35-40mm
SPINECRAFT, LLC
A3X-R3540
Not in Commercial Distribution

  • 00193082082986 ()
  • M824A3XR35401 ()
A3X-R3540

  • Bone-screw internal spinal fixation system connector
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