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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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Dymaxeon - 00815500025244

Rod Gripper - 5.5mm
BACK 2 BASIC DIRECT, LLC
06.0
In Commercial Distribution

  • 00815500025244 ()
77.2048

  • Surgical implant/trial-implant/sizer holder, reusable

Dymaxeon - 00815500025220

Tabletop Rod Cutter
BACK 2 BASIC DIRECT, LLC
05.5
In Commercial Distribution

  • 00815500025220 ()
09.0687

  • Orthopaedic implantable-device cutter

Dymaxeon - 00815500025213

Malleable rod template - 100mm
BACK 2 BASIC DIRECT, LLC
05.5
In Commercial Distribution

  • 00815500025213 ()
09.0799

  • Orthopaedic implant/instrument assembling device

Dymaxeon - 00815500025206

DYMAXEON 5.5 PEDICLE SCREW - CAP INCLUDED SIZE Ø6 x 30mm (GREEN)
BACK 2 BASIC DIRECT, LLC
05.5
In Commercial Distribution

  • 00815500025206 ()
  • 10815500025203 ()
06.6371B

  • Bone-screw internal spinal fixation system, sterile

Dymaxeon - 00815500025190

DYMAXEON 5.5 PEDICLE SCREW - CAP INCLUDED SIZE Ø6 x 25mm (GREEN)
BACK 2 BASIC DIRECT, LLC
05.5
In Commercial Distribution

  • 00815500025190 ()
  • 10815500025197 ()
06.6370B

  • Bone-screw internal spinal fixation system, sterile

Dymaxeon - 00815500025183

DYMAXEON 6.0 PEDICLE SCREW - CAP INCLUDED SIZE Ø5 x 30mm (YELLOW)
BACK 2 BASIC DIRECT, LLC
06.0
In Commercial Distribution

  • 00815500025183 ()
  • 10815500025180 ()
06.6351B

  • Bone-screw internal spinal fixation system, sterile

Dymaxeon - 00815500025176

DYMAXEON 6.0 PEDICLE SCREW - CAP INCLUDED SIZE Ø5 x 25mm (YELLOW)
BACK 2 BASIC DIRECT, LLC
06.0
In Commercial Distribution

  • 00815500025176 ()
  • 10815500025173 ()
06.6350B

  • Bone-screw internal spinal fixation system, sterile

Dymaxeon - 00815500025152

DYMAXEON 6.0 MONOAXIAL PEDICLE SCREW Ø6 x 25mm (GREEN)
BACK 2 BASIC DIRECT, LLC
06.0
In Commercial Distribution

  • 00815500025152 ()
  • 10815500025159 ()
06.2425

  • Bone-screw internal spinal fixation system, sterile

Dymaxeon - 00815500025145

DYMAXEON 6.0 MONOAXIAL PEDICLE SCREW Ø5.5 x 30mm (BLUE)
BACK 2 BASIC DIRECT, LLC
06.0
In Commercial Distribution

  • 00815500025145 ()
  • 10815500025142 ()
06.2330

  • Bone-screw internal spinal fixation system, sterile

Dymaxeon - 00815500024834

DYMAXEON PEDICLE SCREW - CAP INCLUDED SIZE Ø4.5 x 45mm (VIOLET)
BACK 2 BASIC DIRECT, LLC
05.5
In Commercial Distribution

  • 00815500024834 ()
06.6344B-1

  • Bone-screw internal spinal fixation system, sterile
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