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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® - 00815500020010

SINGLE ROD CONNECTOR
BACK 2 BASIC DIRECT, LLC
05.5
Not in Commercial Distribution

  • 00815500020010 ()

  • Length: 22 Millimeter
06.1201B

  • Bone-screw internal spinal fixation system, sterile

Dymaxeon - 00815500025626

Tulip Adjuster
BACK 2 BASIC DIRECT, LLC
06.0
In Commercial Distribution

  • 00815500025626 ()
77.2044

  • Orthopaedic inorganic implant inserter/extractor, reusable

Dymaxeon - 00815500025619

Screw inserter
BACK 2 BASIC DIRECT, LLC
06.0
In Commercial Distribution

  • 00815500025619 ()
77.2068

  • Orthopaedic inorganic implant inserter/extractor, reusable

Dymaxeon - 00815500025602

Screw inserter - ext.
BACK 2 BASIC DIRECT, LLC
06.0
In Commercial Distribution

  • 00815500025602 ()
77.2067

  • Orthopaedic inorganic implant inserter/extractor, reusable

Dymaxeon - 00815500025596

Tray 2 Level 2
BACK 2 BASIC DIRECT, LLC
06.0
In Commercial Distribution

  • 00815500025596 ()
09.0714

  • Instrument tray, reusable

Dymaxeon - 00815500025589

Tray 1 Case
BACK 2 BASIC DIRECT, LLC
06.0
In Commercial Distribution

  • 00815500025589 ()
09.0710

  • Instrument tray, reusable

Dymaxeon - 00815500025565

Malleable rod template - 150mm
BACK 2 BASIC DIRECT, LLC
05.5
In Commercial Distribution

  • 00815500025565 ()
09.0698

  • 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
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