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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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APEX 3D S Total Ankle Replacement System - 00889795136893

Short Stem Tibia, Instrument, Drill Bit Cap D12, Tall
Paragon 28, Inc.
P11-854-C12T
In Commercial Distribution

  • 00889795136893 ()
P11-854-C12T

  • Cannulated surgical drill bit, single-use

APEX 3D S Total Ankle Replacement System - 00889795136886

Short Stem Tibia, Instrument, Drill Bit Cap D12, Short
Paragon 28, Inc.
P11-854-C12S
In Commercial Distribution

  • 00889795136886 ()
P11-854-C12S

  • Cannulated surgical drill bit, single-use

APEX 3D S Total Ankle Replacement System - 00889795136824

Short Stem Tibia, Instrument, Drill Bit Cap D9, Tall
Paragon 28, Inc.
P11-854-C09T
In Commercial Distribution

  • 00889795136824 ()
P11-854-C09T

  • Cannulated surgical drill bit, single-use

Specialty Instrument, Hardware Removal Caddy - 00889795141590

Hardware Removal Caddy, Lid
Paragon 28, Inc.
SP99-LID-0001
In Commercial Distribution

  • 00889795141590 ()
SP99-LID-0001

  • Device sterilization/disinfection container, reusable

Specialty Instrument, Hardware Removal Caddy - 00889795141583

Hardware Removal Caddy, Base
Paragon 28, Inc.
SP99-CAD-0001
In Commercial Distribution

  • 00889795141583 ()
SP99-CAD-0001

  • Device sterilization/disinfection container, reusable

Grappler Interference Screw System - 00889795141538

PCFD Tether, System Tray
Paragon 28, Inc.
P62-CAD-0001
In Commercial Distribution

  • 00889795141538 ()
P62-CAD-0001

  • Device sterilization/disinfection container, reusable

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 - 00889795141477

PCFD Tether, Talar Wire Guide
Paragon 28, Inc.
P62-910-0007
In Commercial Distribution

  • 00889795141477 ()
P62-910-0007

  • Surgical drill guide, 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
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