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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 Total Ankle Replacement System - 00889795097521

APEX 3D™ Tibia, Flat, Left, Size 6, Standard, 3DP
Paragon 28, Inc.
P10-101-BL6S-S
In Commercial Distribution

  • 00889795097521 ()
P10-101-BL6S-S

  • Fixed-bearing total ankle prosthesis

APEX 3D Total Ankle Replacement System - 00889795097507

APEX 3D™ Tibia, Arc, Left, Size 6, Standard, 3DP
Paragon 28, Inc.
P10-100-BL6S-S
In Commercial Distribution

  • 00889795097507 ()
P10-100-BL6S-S

  • Fixed-bearing total ankle prosthesis

Baby Gorilla®/Gorilla® Plating System - 00889795097484

AVITRAC™ Core, MTP Reamer, Ø11 mm
Paragon 28, Inc.
P01-901-1101
In Commercial Distribution

  • 00889795097484 ()
P01-901-1101

  • Bone-resection orthopaedic reamer, reusable

Monster® Screw System - 00889795097460

Precision® JMF™ Screw Washer Caddy Lid
Paragon 28, Inc.
P25-900-WSCL
In Commercial Distribution

  • 00889795097460 ()
P25-900-WSCL

  • Device sterilization/disinfection container, reusable

Monster® Screw System - 00889795097446

Precision® JMF™ Screw Solid Caddy Base
Paragon 28, Inc.
P25-900-SCBS
In Commercial Distribution

  • 00889795097446 ()
P25-900-SCBS

  • Device sterilization/disinfection container, reusable

Monster® Screw System - 00889795097439

1.6mm S/S Tube - No Cap
Paragon 28, Inc.
P25-900-TBE1
In Commercial Distribution

  • 00889795097439 ()
P25-900-TBE1

  • Device sterilization/disinfection container, reusable

Monster® Screw System - 00889795097422

Precision® JMF™ Screw Cannulated Caddy Base
Paragon 28, Inc.
P25-900-SCBC
In Commercial Distribution

  • 00889795097422 ()
P25-900-SCBC

  • Device sterilization/disinfection container, reusable

HammerTube System - 00889795097415

HammerToe, Caddy, Lid
Paragon 28, Inc.
P40-CAD-LID1
In Commercial Distribution

  • 00889795097415 ()
P40-CAD-LID1

  • Device sterilization/disinfection container, reusable

HammerTube System - 00889795097408

HammerToe, Caddy, Insert
Paragon 28, Inc.
P40-CAD-INS1
In Commercial Distribution

  • 00889795097408 ()
P40-CAD-INS1

  • Device sterilization/disinfection container, reusable

HammerTube System - 00889795097392

HammerToe, Caddy, Base
Paragon 28, Inc.
P40-CAD-BASE
In Commercial Distribution

  • 00889795097392 ()
P40-CAD-BASE

  • Device sterilization/disinfection container, reusable
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