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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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Tibia, Arc, Left, Size 2, Standard, 3DP
Paragon 28, Inc.
P10-100-BL2S-S
In Commercial Distribution

  • 00889795142672 ()
P10-100-BL2S-S

  • Fixed-bearing total ankle prosthesis
Tibia, Arc, Left, Size 1, Standard, 3DP
Paragon 28, Inc.
P10-100-BL1S-S
In Commercial Distribution

  • 00889795142658 ()
P10-100-BL1S-S

  • Fixed-bearing total ankle prosthesis
Tibia, Arc, Left, Size 1, Long, 3DP
Paragon 28, Inc.
P10-100-BL1L-S
In Commercial Distribution

  • 00889795142641 ()
P10-100-BL1L-S

  • Fixed-bearing total ankle prosthesis
Tibia, Arc, Left, Size 1, Short, 3DP
Paragon 28, Inc.
P10-100-BL10-S
In Commercial Distribution

  • 00889795142634 ()
P10-100-BL10-S

  • Fixed-bearing total ankle prosthesis
MAVEN PSI TAR, APEX 3D S AP Tibia Spacer, Right
Paragon 28, Inc.
P11-PSI-R105
In Commercial Distribution

  • 00889795142504 ()
P11-PSI-R105

  • Surgical implant template, single-use
MAVEN PSI TAR, APEX 3D S AP Tibia Spacer, Left
Paragon 28, Inc.
P11-PSI-L105
In Commercial Distribution

  • 00889795142498 ()
P11-PSI-L105

  • Surgical implant template, single-use
Hardware Removal Caddy, Base
Paragon 28, Inc.
SP99-CAD-0001
In Commercial Distribution

  • 00889795141583 ()
SP99-CAD-0001

  • Device sterilization/disinfection container, reusable
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
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
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
PCFD Tether, Sustentaculum Wire Guide
Paragon 28, Inc.
P62-910-0006
In Commercial Distribution

  • 00889795141460 ()
P62-910-0006

  • Surgical drill guide, reusable
Removal Hook, Pin
Paragon 28, Inc.
P36-970-0007
In Commercial Distribution

  • 00889795141248 ()
P36-970-0007

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

  • 00889795140692 ()
P11-900-0003

  • Device sterilization/disinfection container, reusable
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 TAR X-ray Templates Packet
Paragon 28, Inc.
P11-900-TEMP
In Commercial Distribution

  • 00889795140661 ()
P11-900-TEMP

  • Surgical implant template, reusable
Short Stem Tibia, Instrument, Drill Wrench
Paragon 28, Inc.
P11-854-WR01
In Commercial Distribution

  • 00889795140647 ()
P11-854-WR01

  • Surgical torque wrench, reusable
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
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