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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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Precision MIS Bunion System - 00889795131645

Precision MIS Screw, Cannulated, Ø3.0 x 48mm
Paragon 28, Inc.
P27-130-0048
In Commercial Distribution

  • 00889795131645 ()
P27-130-0048

  • Orthopaedic bone screw (non-sliding)

Precision MIS Bunion System - 00889795131638

Precision MIS Screw, Cannulated, Ø3.0 x 46mm
Paragon 28, Inc.
P27-130-0046
In Commercial Distribution

  • 00889795131638 ()
P27-130-0046

  • Orthopaedic bone screw (non-sliding)

Precision MIS Bunion System - 00889795131621

Precision MIS Screw, Cannulated, Ø3.0 x 44mm
Paragon 28, Inc.
P27-130-0044
In Commercial Distribution

  • 00889795131621 ()
P27-130-0044

  • Orthopaedic bone screw (non-sliding)

Precision MIS Bunion System - 00889795131614

Precision MIS Screw, Cannulated, Ø3.0 x 42mm
Paragon 28, Inc.
P27-130-0042
In Commercial Distribution

  • 00889795131614 ()
P27-130-0042

  • Orthopaedic bone screw (non-sliding)

Precision MIS Bunion System - 00889795131607

Precision MIS Screw, Cannulated, Ø3.0 x 40mm
Paragon 28, Inc.
P27-130-0040
In Commercial Distribution

  • 00889795131607 ()
P27-130-0040

  • Orthopaedic bone screw (non-sliding)

Precision MIS Bunion System - 00889795131591

Precision MIS Screw, Cannulated, Ø3.0 x 38mm
Paragon 28, Inc.
P27-130-0038
In Commercial Distribution

  • 00889795131591 ()
P27-130-0038

  • Orthopaedic bone screw (non-sliding)

Precision MIS Bunion System - 00889795131584

Precision MIS Screw, Cannulated, Ø3.0 x 36mm
Paragon 28, Inc.
P27-130-0036
In Commercial Distribution

  • 00889795131584 ()
P27-130-0036

  • Orthopaedic bone screw (non-sliding)

Precision MIS Bunion System - 00889795131577

Precision MIS Screw, Cannulated, Ø3.0 x 34mm
Paragon 28, Inc.
P27-130-0034
In Commercial Distribution

  • 00889795131577 ()
P27-130-0034

  • Orthopaedic bone screw (non-sliding)

Precision MIS Bunion System - 00889795131560

Precision MIS Screw, Cannulated, Ø3.0 x 32mm
Paragon 28, Inc.
P27-130-0032
In Commercial Distribution

  • 00889795131560 ()
P27-130-0032

  • Orthopaedic bone screw (non-sliding)

Precision MIS Bunion System - 00889795131553

Precision MIS Screw, Cannulated, Ø3.0 x 30mm
Paragon 28, Inc.
P27-130-0030
In Commercial Distribution

  • 00889795131553 ()
P27-130-0030

  • Orthopaedic bone screw (non-sliding)

Precision MIS Bunion System - 00889795131546

Precision MIS Screw, Cannulated, Ø3.0 x 28mm
Paragon 28, Inc.
P27-130-0028
In Commercial Distribution

  • 00889795131546 ()
P27-130-0028

  • Orthopaedic bone screw (non-sliding)

Precision MIS Bunion System - 00889795131539

Precision MIS Screw, Cannulated, Ø3.0 x 26mm
Paragon 28, Inc.
P27-130-0026
In Commercial Distribution

  • 00889795131539 ()
P27-130-0026

  • Orthopaedic bone screw (non-sliding)

Precision MIS Bunion System - 00889795131522

Precision MIS Screw, Cannulated, Ø3.0 x 24mm
Paragon 28, Inc.
P27-130-0024
In Commercial Distribution

  • 00889795131522 ()
P27-130-0024

  • Orthopaedic bone screw (non-sliding)

Precision MIS Bunion System - 00889795131515

Precision MIS Screw, Cannulated, Ø3.0 x 22mm
Paragon 28, Inc.
P27-130-0022
In Commercial Distribution

  • 00889795131515 ()
P27-130-0022

  • Orthopaedic bone screw (non-sliding)

Precision MIS Bunion System - 00889795131508

Precision MIS Screw, Cannulated, Ø3.0 x 20mm
Paragon 28, Inc.
P27-130-0020
In Commercial Distribution

  • 00889795131508 ()
P27-130-0020

  • Orthopaedic bone screw (non-sliding)

Precision MIS Bunion System - 00889795131492

Precision MIS Screw, Cannulated, Ø3.0 x 18mm
Paragon 28, Inc.
P27-130-0018
In Commercial Distribution

  • 00889795131492 ()
P27-130-0018

  • Orthopaedic bone screw (non-sliding)

Precision MIS Bunion System - 00889795131485

Precision MIS Screw, Cannulated, Ø3.0 x 16mm
Paragon 28, Inc.
P27-130-0016
In Commercial Distribution

  • 00889795131485 ()
P27-130-0016

  • Orthopaedic bone screw (non-sliding)

Precision MIS Bunion System - 00889795131478

Precision MIS Screw, Cannulated, Ø3.0 x 14mm
Paragon 28, Inc.
P27-130-0014
In Commercial Distribution

  • 00889795131478 ()
P27-130-0014

  • Orthopaedic bone screw (non-sliding)

Precision MIS Bunion System - 00889795131461

Precision MIS Screw, Cannulated, Ø3.0 x 12mm
Paragon 28, Inc.
P27-130-0012
In Commercial Distribution

  • 00889795131461 ()
P27-130-0012

  • Orthopaedic bone screw (non-sliding)

Phantom Hindfoot TTC/TC Nail System - 00889795131454

Phantom Hindfoot Explant Base Lid
Paragon 28, Inc.
P31-906-LID
In Commercial Distribution

  • 00889795131454 ()
P31-906-LID

  • Device sterilization/disinfection container, reusable

Phantom Hindfoot TTC/TC Nail System - 00889795131430

Phantom Hindfoot Explant Tray 2
Paragon 28, Inc.
P31-906-TRY2
In Commercial Distribution

  • 00889795131430 ()
P31-906-TRY2

  • Device sterilization/disinfection container, reusable

Phantom Hindfoot TTC/TC Nail System - 00889795131423

Phantom Hindfoot Explant Tip Caddy
Paragon 28, Inc.
P31-906-EXTT
In Commercial Distribution

  • 00889795131423 ()
P31-906-EXTT

  • Device sterilization/disinfection container, reusable

Phantom Hindfoot TTC/TC Nail System - 00889795131416

Phantom Hindfoot Explant Tray 1
Paragon 28, Inc.
P31-906-TRY1
In Commercial Distribution

  • 00889795131416 ()
P31-906-TRY1

  • Device sterilization/disinfection container, reusable

Phantom Hindfoot TTC/TC Nail System - 00889795131409

Phantom Hindfoot Explant Base 1
Paragon 28, Inc.
P31-906-BASE
In Commercial Distribution

  • 00889795131409 ()
P31-906-BASE

  • Device sterilization/disinfection container, reusable

Bun-Yo-Matic™ Lapidus Clamp System - 00889795131393

Bun-Yo-Matic, Anti-Penetration Tool
Paragon 28, Inc.
P30-960-1214
In Commercial Distribution

  • 00889795131393 ()
P30-960-1214

  • Orthopaedic implantation sleeve, reusable

Bun-Yo-Matic™ Lapidus Clamp System - 00889795131386

K-Wire, Olive, Threaded, Ø1.8mm x 4.7cm
Paragon 28, Inc.
P99-251-1604
In Commercial Distribution

  • 00889795131386 ()
P99-251-1604

  • Orthopaedic guidewire, single-use

Bun-Yo-Matic™ Lapidus Clamp System - 00889795131379

Bun-Yo-Matic, Cuneiform Cut Guide, Right
Paragon 28, Inc.
P30-960-1213R
In Commercial Distribution

  • 00889795131379 ()
P30-960-1213R

  • Osteotomy guide, reusable

Bun-Yo-Matic™ Lapidus Clamp System - 00889795131362

Bun-Yo-Matic, Cuneiform Cut Guide, Left
Paragon 28, Inc.
P30-960-1213L
In Commercial Distribution

  • 00889795131362 ()
P30-960-1213L

  • Osteotomy guide, reusable

Bun-Yo-Matic™ Lapidus Clamp System - 00889795131355

Bun-Yo-Matic, Met Cut Guide, Right
Paragon 28, Inc.
P30-960-1212R
In Commercial Distribution

  • 00889795131355 ()
P30-960-1212R

  • Osteotomy guide, reusable

Bun-Yo-Matic™ Lapidus Clamp System - 00889795131348

Bun-Yo-Matic, Met Cut Guide, Left
Paragon 28, Inc.
P30-960-1212L
In Commercial Distribution

  • 00889795131348 ()
P30-960-1212L

  • Osteotomy guide, reusable

Bun-Yo-Matic™ Lapidus Clamp System - 00889795131331

Bun-Yo-Matic, Weight Bearing Wedge
Paragon 28, Inc.
P30-960-1211
In Commercial Distribution

  • 00889795131331 ()
P30-960-1211

  • Osteotomy guide, reusable

Bun-Yo-Matic™ Lapidus Clamp System - 00889795131324

Bun-Yo-Matic, K-wire, Ø2.30mm x 19cm, Smooth
Paragon 28, Inc.
P30-196-2319
In Commercial Distribution

  • 00889795131324 ()
P30-196-2319

  • Orthopaedic guidewire, single-use

Monkey Rings™ External Fixation System - 00889795131317

Ball Joint Strut Wrench
Paragon 28, Inc.
P45-517-0010
In Commercial Distribution

  • 00889795131317 ()
P45-517-0010

  • Surgical torque wrench, reusable

FJ2000 System - 00889795131287

Shannon-style Recta Bone Burr, 2.2 x 20 x 100, AO (Sterile)
Paragon 28, Inc.
P65-105-2222-S
In Commercial Distribution

  • 00889795131287 ()
P65-105-2222-S

  • Orthopaedic bur, single-use

FJ2000 System - 00889795131270

FJ-2000, Screw for Foot Hook
Paragon 28, Inc.
P65-002-0008
In Commercial Distribution

  • 00889795131270 ()
P65-002-0008

  • Surgical power tool system control unit, line-powered

FJ2000 System - 00889795131263

FJ-2000, Foot Hook
Paragon 28, Inc.
P65-002-0007
In Commercial Distribution

  • 00889795131263 ()
P65-002-0007

  • Surgical power tool system control unit, line-powered

FJ2000 System - 00889795131256

FJ-2000, Hardware for Fluid Bag
Paragon 28, Inc.
P65-002-0006
In Commercial Distribution

  • 00889795131256 ()
P65-002-0006

  • Surgical power tool system control unit, line-powered

FJ2000 System - 00889795131225

FJ-2000, Power Cord US Version 100V
Paragon 28, Inc.
P65-002-0003
In Commercial Distribution

  • 00889795131225 ()
P65-002-0003

  • Surgical power tool system control unit, line-powered

FJ2000 System - 00889795131218

FJ-2000, Foot Pedal
Paragon 28, Inc.
P65-002-0002
In Commercial Distribution

  • 00889795131218 ()
P65-002-0002

  • Surgical power tool system control unit, line-powered

FJ2000 System - 00889795131201

FJ-2000, Power Console with Irrigation Pump
Paragon 28, Inc.
P65-002-0001
In Commercial Distribution

  • 00889795131201 ()
P65-002-0001

  • Surgical power tool system control unit, line-powered
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