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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 - 00815500025589

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

  • 00815500025589 ()
09.0710

  • Instrument tray, reusable

Dymaxeon - 00815500025572

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

  • 00815500025572 ()
09.0673

  • 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 - 00815500025558

Counter torque with comfort handle
BACK 2 BASIC DIRECT, LLC
05.5
In Commercial Distribution

  • 00815500025558 ()
09.0685

  • Orthopaedic counter-torque/rod-pushing instrument

Dymaxeon - 00815500025541

Tower torque with 1/4 inch square drive
BACK 2 BASIC DIRECT, LLC
05.5
In Commercial Distribution

  • 00815500025541 ()
09.0681

  • Surgical torque wrench, reusable

Dymaxeon - 00815500025534

Tap - 7.0mm
BACK 2 BASIC DIRECT, LLC
05.5
In Commercial Distribution

  • 00815500025534 ()
09.0737

  • Bone tap, reusable

Dymaxeon - 00815500025527

Tap - 6.0mm
BACK 2 BASIC DIRECT, LLC
05.5
In Commercial Distribution

  • 00815500025527 ()
09.0736

  • Bone tap, reusable

Dymaxeon - 00815500025510

Tap - 5.0mm
BACK 2 BASIC DIRECT, LLC
05.5
In Commercial Distribution

  • 00815500025510 ()
09.0705

  • Bone tap, reusable

Dymaxeon - 00815500025503

Tap - 4.0mm
BACK 2 BASIC DIRECT, LLC
05.5
In Commercial Distribution

  • 00815500025503 ()
09.0704

  • Bone tap, reusable

Dymaxeon - 00815500025497

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

  • 00815500025497 ()
09.0727

  • Abdominal/ENT/orthopaedic surgical probe, reusable

Dymaxeon - 00815500025480

Rod Rocker
BACK 2 BASIC DIRECT, LLC
06.0
In Commercial Distribution

  • 00815500025480 ()
09.0722

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

Dymaxeon - 00815500025473

Ratchet, Stealth T Internal Adapter 1/4"
BACK 2 BASIC DIRECT, LLC
06.0
In Commercial Distribution

  • 00815500025473 ()
09.0655

  • Surgical torque wrench adaptor

Dymaxeon - 00815500025459

Vertebral Rod aligner
BACK 2 BASIC DIRECT, LLC
05.5
In Commercial Distribution

  • 00815500025459 ()
09.0674

  • Orthopaedic fixation implant alignment tool

Dymaxeon - 00815500025442

Closed lateral connector (60mm)
BACK 2 BASIC DIRECT, LLC
05.5
Not in Commercial Distribution

  • 00815500025442 ()
46.4247

  • Bone-screw internal spinal fixation system, sterile

Dymaxeon - 00815500025435

Closed lateral connector (40mm)
BACK 2 BASIC DIRECT, LLC
05.5
Not in Commercial Distribution

  • 00815500025435 ()
46.4246

  • Bone-screw internal spinal fixation system, sterile

Dymaxeon - 00815500025428

Closed lateral connector (30mm)
BACK 2 BASIC DIRECT, LLC
05.5
Not in Commercial Distribution

  • 00815500025428 ()
46.4245

  • Bone-screw internal spinal fixation system, sterile

Dymaxeon - 00815500025411

Closed lateral connector (20mm)
BACK 2 BASIC DIRECT, LLC
05.5
Not in Commercial Distribution

  • 00815500025411 ()
46.4244

  • Bone-screw internal spinal fixation system, sterile

Dymaxeon - 00815500025404

Open Lateral Connector (60mm)
BACK 2 BASIC DIRECT, LLC
05.5
Not in Commercial Distribution

  • 00815500025404 ()
46.4243

  • Bone-screw internal spinal fixation system, sterile

Dymaxeon - 00815500025398

Open Lateral Connector (40mm)
BACK 2 BASIC DIRECT, LLC
05.5
Not in Commercial Distribution

  • 00815500025398 ()
46.4242

  • Bone-screw internal spinal fixation system, sterile

Dymaxeon - 00815500025381

Open Lateral Connector (30mm)
BACK 2 BASIC DIRECT, LLC
05.5
Not in Commercial Distribution

  • 00815500025381 ()
46.4241

  • Bone-screw internal spinal fixation system, sterile
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