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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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Grappler Interference Screw System - 00889795141439

PCFD Tether, Targeting Guide Assembly
Paragon 28, Inc.
P62-910-0001
In Commercial Distribution

  • 00889795141439 ()
P62-910-0001

  • Surgical drill guide, reusable

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

Monkey Bars™ Pin to Bar External Fixation System - 00889795140739

11mm Bar and 5mm Pin Combination Clamp
Paragon 28, Inc.
P85-310-1105
In Commercial Distribution

  • 00889795140739 ()
P85-310-1105

  • External orthopaedic fixation system, single-use

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 - 00889795140708

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

  • 00889795140708 ()
P11-900-CASB

  • 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

APEX 3D S Total Ankle Replacement System - 00889795140661

Apex 3D-S TAR X-ray Templates Packet
Paragon 28, Inc.
P11-900-TEMP
In Commercial Distribution

  • 00889795140661 ()
P11-900-TEMP

  • Surgical implant template, reusable

APEX 3D S Total Ankle Replacement System - 00889795140647

Short Stem Tibia, Instrument, Drill Wrench
Paragon 28, Inc.
P11-854-WR01
In Commercial Distribution

  • 00889795140647 ()
P11-854-WR01

  • Surgical torque wrench, reusable

APEX 3D Total Ankle Replacement System - 00889795140630

Right Angle Drill - Hex Socket Driver
Paragon 28, Inc.
P11-854-RAD1-17
In Commercial Distribution

  • 00889795140630 ()
P11-854-RAD1-17

  • Surgical screwdriver, reusable
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