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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 - 00815500023493

Distractor - 5.5mm
BACK 2 BASIC DIRECT, LLC
05.5
In Commercial Distribution

  • 00815500023493 ()
09.0666

  • Orthopaedic surgical distractor, internal

Dymaxeon - 00815500023455

Torque Limiting Wrench Handle
BACK 2 BASIC DIRECT, LLC
06.0
In Commercial Distribution

  • 00815500023455 ()
09.0726

  • Surgical instrument handle, torque-limiting

Dymaxeon - 00815500023424

Sounder - malleable
BACK 2 BASIC DIRECT, LLC
06.0
In Commercial Distribution

  • 00815500023424 ()
09.0653

  • Abdominal/ENT/orthopaedic surgical probe, reusable

Dymaxeon - 00815500023417

Probe - Curved - Palm Handle
BACK 2 BASIC DIRECT, LLC
05.5
In Commercial Distribution

  • 00815500023417 ()
09.0652

  • Surgical instrument handle, non-torque-limiting

Dymaxeon - 00815500023301

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

  • 00815500023301 ()
06.6341B-1

  • Bone-screw internal spinal fixation system, sterile

Dymaxeon® - 00815500023196

DYMAXEON 5.5 POLYAXIAL SPONDYLOLISTHESIS CANNULATED SCREW Ø5.5X55mm (GREEN)
BACK 2 BASIC DIRECT, LLC
05.5
Not in Commercial Distribution

  • 00815500023196 ()
  • 10815500023193 ()

  • Length: 55 Millimeter
06.6633B

  • Bone-screw internal spinal fixation system, sterile

Dymaxeon® - 00815500023189

DYMAXEON 5.5 POLYAXIAL SPONDYLOLISTHESIS CANNULATED SCREW Ø5.5X50mm (BLUE)
BACK 2 BASIC DIRECT, LLC
05.5
In Commercial Distribution

  • 00815500023189 ()
  • 10815500023186 ()

  • Length: 50 Millimeter
06.6632B

  • Bone-screw internal spinal fixation system, sterile

Dymaxeon® - 00815500023066

DYMAXEON 5.5 OPEN POLYAXIAL PEDICULAR CANNULATED SCREW Ø7,5 x80mm (VIOLET)
BACK 2 BASIC DIRECT, LLC
05.5
In Commercial Distribution

  • 00815500023066 ()
  • 10815500023063 ()

  • Length: 80 Millimeter
06.6607B

  • Bone-screw internal spinal fixation system, sterile

Dymaxeon® - 00815500023059

DYMAXEON 5.5 OPEN POLYAXIAL PEDICULAR CANNULATED SCREW Ø7,5 x70mm (VIOLET)
BACK 2 BASIC DIRECT, LLC
05.5
In Commercial Distribution

  • 00815500023059 ()
  • 10815500023056 ()

  • Length: 70 Millimeter
06.6606B

  • Bone-screw internal spinal fixation system, sterile

Dymaxeon® - 00815500023042

DYMAXEON 5.5 OPEN POLYAXIAL PEDICULAR CANNULATED SCREW Ø7,5 x60mm (VIOLET)
BACK 2 BASIC DIRECT, LLC
05.5
In Commercial Distribution

  • 00815500023042 ()
  • 10815500023049 ()

  • Length: 60 Millimeter
06.6605B

  • Bone-screw internal spinal fixation system, sterile
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