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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 - 00815500023479

Torque axial - medium - 12 in-lbs
BACK 2 BASIC DIRECT, LLC
05.5
In Commercial Distribution

  • 00815500023479 ()
09.0675

  • Surgical torque wrench, reusable

Dymaxeon - 00815500023462

Coupler- Torque
BACK 2 BASIC DIRECT, LLC
06.0
In Commercial Distribution

  • 00815500023462 ()
77.2051

  • Orthopaedic implant/instrument assembling device

Dymaxeon - 00815500023448

Cap starter
BACK 2 BASIC DIRECT, LLC
06.0
In Commercial Distribution

  • 00815500023448 ()
77.1897

  • Surgical screwdriver, reusable

Dymaxeon - 00815500023325

SINGLE-PACKED DYMAXEON PEDICLE SCREW - CANNULATED - CAP INCLUDED Ø4.5 X 30MM
BACK 2 BASIC DIRECT, LLC
5.5
In Commercial Distribution

  • 00815500023325 ()
06.6541B-1

  • Bone-screw internal spinal fixation system, sterile

Dymaxeon - 00815500023318

SINGLE-PACKED DYMAXEON PEDICLE SCREW - CANNULATED - CAP INCLUDED Ø4.5 X 25MM
BACK 2 BASIC DIRECT, LLC
5.5
In Commercial Distribution

  • 00815500023318 ()
06.6540B-1

  • Bone-screw internal spinal fixation system, sterile

Dymaxeon - 00815500023295

SINGLE-PACKED DYMAXEON PEDICLE SCREW - CAP INCLUDED SIZE Ø4.5 X 25MM
BACK 2 BASIC DIRECT, LLC
5.5
In Commercial Distribution

  • 00815500023295 ()
06.6340B-1

  • Bone-screw internal spinal fixation system, sterile

Dymaxeon® - 00815500023288

DYMAXEON OPEN POLYAXIAL PEDICULAR SCREW Ø7.5 x45mm (VIOLET)
BACK 2 BASIC DIRECT, LLC
06.0
In Commercial Distribution

  • 00815500023288 ()
  • 10815500023285 ()

  • Length: 45 Millimeter
06.3401B

  • Bone-screw internal spinal fixation system, sterile

Dymaxeon® - 00815500023271

DYMAXEON 5.5 POLYAXIAL SPONDYLOLISTHESIS CANNULATED SCREW Ø6.5X80mm (GREEN)
BACK 2 BASIC DIRECT, LLC
05.5
In Commercial Distribution

  • 00815500023271 ()
  • 10815500023278 ()

  • Length: 80 Millimeter
06.6639B

  • Bone-screw internal spinal fixation system, sterile

Dymaxeon® - 00815500023264

DYMAXEON 5.5 POLYAXIAL SPONDYLOLISTHESIS CANNULATED SCREW Ø6.5X70mm (GREEN)
BACK 2 BASIC DIRECT, LLC
05.5
In Commercial Distribution

  • 00815500023264 ()
  • 10815500023261 ()

  • Length: 70 Millimeter
06.6638B

  • Bone-screw internal spinal fixation system, sterile

Dymaxeon® - 00815500023257

DYMAXEON 5.5 POLYAXIAL SPONDYLOLISTHESIS CANNULATED SCREW Ø6.5X60mm (GREEN)
BACK 2 BASIC DIRECT, LLC
05.5
In Commercial Distribution

  • 00815500023257 ()
  • 10815500023254 ()

  • Length: 60 Millimeter
06.6637B

  • Bone-screw internal spinal fixation system, sterile
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