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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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Steerable IBD - 10889981117290

Fixed Rasp; 22x7 (05-3307)
Seaspine Orthopedics Corporation
29-22-2207
In Commercial Distribution

  • 10889981117290 ()

  • 22x7
29-22-2207

  • Bone file/rasp, manual, reusable

Coral - 10889981117269

6.5 Screw Caddy
Seaspine Orthopedics Corporation
28-99-0001-1-4
In Commercial Distribution

  • 10889981117269 ()

  • 6.5mm
28-99-0001-1-4

  • Instrument tray, reusable

Coral - 10889981117238

Rod Caddy
Seaspine Orthopedics Corporation
28-99-0001-1-1
In Commercial Distribution

  • 10889981117238 ()
28-99-0001-1-1

  • Instrument tray, reusable

Coral - 10889981117221

Coral MIS Implant Tray
Seaspine Orthopedics Corporation
28-99-0001
In Commercial Distribution

  • 10889981117221 ()
28-99-0001

  • Instrument tray, reusable

TAPERLOC® - 00880304430747

No Description
Biomet Orthopedics, LLC
31-121406
In Commercial Distribution

  • 00880304430747 ()

  • 17.5MM - 25.0MM, STANDARD
31-121406

  • Femoral stem prosthesis trial

TAPERLOC® - 00880304430723

No Description
Biomet Orthopedics, LLC
31-121405
In Commercial Distribution

  • 00880304430723 ()

  • 10.0MM - 15.0MM, STANDARD
31-121405

  • Femoral stem prosthesis trial

Coral - 10889981117177

Compressor Handle
Seaspine Orthopedics Corporation
28-40-0082
In Commercial Distribution

  • 10889981117177 ()
28-40-0082

  • Surgical instrument handle, non-torque-limiting

Coral - 10889981117160

Distractor Handle
Seaspine Orthopedics Corporation
28-40-0081
In Commercial Distribution

  • 10889981117160 ()
28-40-0081

  • Surgical instrument handle, non-torque-limiting

Coral - 10889981117139

Locking Screw Final Tightener
Seaspine Orthopedics Corporation
28-40-0071
In Commercial Distribution

  • 10889981117139 ()
28-40-0071

  • Surgical screwdriver, reusable

Coral - 10889981117122

Locking Screw Inserter, Long
Seaspine Orthopedics Corporation
28-40-0070-308
In Commercial Distribution

  • 10889981117122 ()
28-40-0070-308

  • Orthopaedic inorganic implant inserter/extractor, reusable
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