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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 - 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

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 S Total Ankle Replacement System - 00889795140616

Short Stem Tibia, Instrument, Right Angle Drill
Paragon 28, Inc.
P11-854-RAD1
In Commercial Distribution

  • 00889795140616 ()
P11-854-RAD1

  • Fluted surgical drill bit, reusable

APEX 3D S Total Ankle Replacement System - 00889795140593

Short Stem Tibia, Instrument, Linear Guide Rail
Paragon 28, Inc.
P11-854-LG10
In Commercial Distribution

  • 00889795140593 ()
P11-854-LG10

  • Osteotomy guide, reusable

APEX 3D S Total Ankle Replacement System - 00889795140494

Short Stem Tibia, Instrument, Forked Paddle, Flat
Paragon 28, Inc.
P11-851-P041
In Commercial Distribution

  • 00889795140494 ()
P11-851-P041

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

APEX 3D S Total Ankle Replacement System - 00889795140487

Short Stem Tibia, Instrument, Flat Paddle - 2
Paragon 28, Inc.
P11-851-P032
In Commercial Distribution

  • 00889795140487 ()
P11-851-P032

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