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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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Bun-Yo-Matic™ Lapidus Clamp System - 00889795129192

Bun-Yo-Matic, Rotator, Right
Paragon 28, Inc.
P30-960-1201R
In Commercial Distribution

  • 00889795129192 ()
P30-960-1201R

  • Osteotomy guide, reusable

Bun-Yo-Matic™ Lapidus Clamp System - 00889795129185

Bun-Yo-Matic, Rotator, Left
Paragon 28, Inc.
P30-960-1201L
In Commercial Distribution

  • 00889795129185 ()
P30-960-1201L

  • Osteotomy guide, reusable

Monkey Rings™ External Fixation System - 00889795129154

Russian Wire Bolt
Paragon 28, Inc.
P45-913-2011
In Commercial Distribution

  • 00889795129154 ()
P45-913-2011

  • External orthopaedic fixation system, single-use

Monkey Rings™ External Fixation System - 00889795129123

Long Range Tensioner Tip
Paragon 28, Inc.
P45-540-0003
In Commercial Distribution

  • 00889795129123 ()
P45-540-0003

  • Orthopaedic prosthesis implantation positioning instrument, reusable

Bun-Yo-Matic™ Lapidus Clamp System - 00889795129055

Saw Blade 39 x 10 x 0.4/0.6mm, Stryker (Sterile)
Paragon 28, Inc.
P99-151-P302-S
In Commercial Distribution

  • 00889795129055 ()
P99-151-P302-S

  • Surgical saw blade, sagittal, single-use

Bun-Yo-Matic™ Lapidus Clamp System - 00889795129048

Saw Blade 39 x 10 x 0.4/0.6mm, MicroAire (Sterile)
Paragon 28, Inc.
P99-151-P301-S
In Commercial Distribution

  • 00889795129048 ()
P99-151-P301-S

  • Surgical saw blade, sagittal, single-use

MISTER Tendon Harvester - 00889795128751

Tendon Harvester & Dilator Sterile Kit
Paragon 28, Inc.
P68-101-0000-SK
In Commercial Distribution

  • 00889795128751 ()
P68-101-0000-SK

  • Orthopaedic surgical procedure kit, non-medicated, reusable

Lesser Metatarsal Shortening System - 00889795128744

K-Wire, Single Ended Trocar Tip, 1.30mm x 8cm
Paragon 28, Inc.
P35-941-1308
In Commercial Distribution

  • 00889795128744 ()
P35-941-1308

  • Orthopaedic bone wire

APEX 3D Total Ankle Replacement System - 00889795128621

APEX 3D Total Ankle Replacement System, Large Instrumentation, Tray
Paragon 28, Inc.
P10-800-0006
In Commercial Distribution

  • 00889795128621 ()
P10-800-0006

  • Device sterilization/disinfection container, reusable

APEX 3D Total Ankle Replacement System - 00889795128614

APEX 3D Total Ankle Replacement System, Impaction, Tray
Paragon 28, Inc.
P10-800-0005
In Commercial Distribution

  • 00889795128614 ()
P10-800-0005

  • Device sterilization/disinfection container, reusable
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