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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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Monkey Bars™ Pin to Bar External Fixation System - 00889795141569

175mm X 210mm Carbon Bar Kickstand
Paragon 28, Inc.
P85-410-128U
In Commercial Distribution

  • 00889795141569 ()
P85-410-128U

  • External orthopaedic fixation system, single-use

Grappler Interference Screw System - 00889795141521

1.6 X 20cm, Eyelet K-wire w/ Markings
Paragon 28, Inc.
P62-197-1620
In Commercial Distribution

  • 00889795141521 ()
P62-197-1620

  • Orthopaedic guidewire, single-use

Grappler Interference Screw System - 00889795141491

PCFD Tether, Sinus Tarsai Dilator
Paragon 28, Inc.
P62-910-0009
In Commercial Distribution

  • 00889795141491 ()
P62-910-0009

  • Orthopaedic surgical procedure kit, non-medicated, reusable

Grappler Interference Screw System - 00889795141460

PCFD Tether, Sustentaculum Wire Guide
Paragon 28, Inc.
P62-910-0006
In Commercial Distribution

  • 00889795141460 ()
P62-910-0006

  • Surgical drill guide, reusable

Phantom® Fibula Nail System - 00889795141248

Removal Hook, Pin
Paragon 28, Inc.
P36-970-0007
In Commercial Distribution

  • 00889795141248 ()
P36-970-0007

  • Bone hook

APEX 3D Total Ankle Replacement System - 00889795141217

APEX 3D-PS Total Ankle Replacement System, Small Tray
Paragon 28, Inc.
P10-800-0007
In Commercial Distribution

  • 00889795141217 ()
P10-800-0007

  • Device sterilization/disinfection container, reusable

Monkey Bars™ Pin to Bar External Fixation System - 00889795140821

Ratcheting T-Handle, AO and 10mm Socket
Paragon 28, Inc.
P85-000-316T
In Commercial Distribution

  • 00889795140821 ()
P85-000-316T

  • Surgical instrument handle, non-torque-limiting

APEX 3D S Total Ankle Replacement System - 00889795140715

Short Stem Tibia System, Instrument Case, Lid
Paragon 28, Inc.
P11-900-CASL
In Commercial Distribution

  • 00889795140715 ()
P11-900-CASL

  • Device sterilization/disinfection container, reusable

APEX 3D S Total Ankle Replacement System - 00889795140692

Short Stem Tibia System, Drill Caddy
Paragon 28, Inc.
P11-900-0003
In Commercial Distribution

  • 00889795140692 ()
P11-900-0003

  • Device sterilization/disinfection container, reusable

APEX 3D S Total Ankle Replacement System - 00889795140685

Short Stem Tibia System, Tray 2
Paragon 28, Inc.
P11-900-0002
In Commercial Distribution

  • 00889795140685 ()
P11-900-0002

  • Device sterilization/disinfection container, reusable
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