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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 - M824A3ZR3572001

ASTRA-OCT Dia. 3.5mm Ti Z-Rod, 7mm Offset, 200mm
SPINECRAFT, LLC
A3ZR-357-200
In Commercial Distribution

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

  • Bone-screw internal spinal fixation system, non-sterile

ASTRA-OCT Spine System - M824A3ZR357100K1

ASTRA-OCT Dia. 3.5mm CoCr Z-Rod, 7mm Offset, 100mm
SPINECRAFT, LLC
A3ZR-357-100K
In Commercial Distribution

  • 00193082083488 ()
  • M824A3ZR357100K1 ()
A3ZR-357-100K

  • Bone-screw internal spinal fixation system, non-sterile

ASTRA-OCT Spine System - M824A3ZR3571001

ASTRA-OCT Dia. 3.5mm Ti Z-Rod, 7mm Offset, 100mm
SPINECRAFT, LLC
A3ZR-357-100
In Commercial Distribution

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

  • Bone-screw internal spinal fixation system, non-sterile

ASTRA-OCT Spine System - M824A3XS491

ASTRA-OCT Screw-to-Screw Cross Connector, 49mm
SPINECRAFT, LLC
A3X-S49
In Commercial Distribution

  • 00193082083044 ()
  • M824A3XS491 ()
A3X-S49

  • Bone-screw internal spinal fixation system, non-sterile

ASTRA-OCT Spine System - M824A3XS451

ASTRA-OCT Screw-to-Screw Cross Connector, 45mm
SPINECRAFT, LLC
A3X-S45
In Commercial Distribution

  • 00193082083037 ()
  • M824A3XS451 ()
A3X-S45

  • Bone-screw internal spinal fixation system, non-sterile

ASTRA-OCT Spine System - M824A3XS411

ASTRA-OCT Screw-to-Screw Cross Connector, 41mm
SPINECRAFT, LLC
A3X-S41
In Commercial Distribution

  • 00193082083020 ()
  • M824A3XS411 ()
A3X-S41

  • Bone-screw internal spinal fixation system, non-sterile

ASTRA-OCT Spine System - M824A3XS371

ASTRA-OCT Screw-to-Screw Cross Connector, 37mm
SPINECRAFT, LLC
A3X-S37
In Commercial Distribution

  • 00193082083013 ()
  • M824A3XS371 ()
A3X-S37

  • Bone-screw internal spinal fixation system, non-sterile

ASTRA-OCT Spine System - M824A3XS331

ASTRA-OCT Screw-to-Screw Cross Connector, 33mm
SPINECRAFT, LLC
A3X-S33
In Commercial Distribution

  • 00193082083006 ()
  • M824A3XS331 ()
A3X-S33

  • Bone-screw internal spinal fixation system, non-sterile

ASTRA-OCT Spine System - M824A3XR39491

ASTRA-OCT Adjustable Rod-to-Rod Cross Connector, 39-49mm
SPINECRAFT, LLC
A3X-R3949
In Commercial Distribution

  • 00193082082993 ()
  • M824A3XR39491 ()
A3X-R3949

  • Bone-screw internal spinal fixation system, non-sterile

ASTRA-OCT Spine System - M824A3XR35401

ASTRA-OCT Adjustable Rod-to-Rod Cross Connector, 35-40mm
SPINECRAFT, LLC
A3X-R3540
In Commercial Distribution

  • 00193082082986 ()
  • M824A3XR35401 ()
A3X-R3540

  • Bone-screw internal spinal fixation system, non-sterile
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