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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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Phantom Hindfoot TTC/TC Nail System - 00889795130877

Screw Remover, Med
Paragon 28, Inc.
P31-958-3012
In Commercial Distribution

  • 00889795130877 ()
P31-958-3012

  • Bone-resection orthopaedic reamer, single-use

Phantom Hindfoot TTC/TC Nail System - 00889795130860

Screw Remover, Large
Paragon 28, Inc.
P31-958-3011
In Commercial Distribution

  • 00889795130860 ()
P31-958-3011

  • Bone-resection orthopaedic reamer, single-use

Phantom Hindfoot TTC/TC Nail System - 00889795130853

Screw Reamer, Small
Paragon 28, Inc.
P31-958-3003
In Commercial Distribution

  • 00889795130853 ()
P31-958-3003

  • Bone-resection orthopaedic reamer, single-use

Phantom Hindfoot TTC/TC Nail System - 00889795130846

Screw Reamer, Med
Paragon 28, Inc.
P31-958-3002
In Commercial Distribution

  • 00889795130846 ()
P31-958-3002

  • Bone-resection orthopaedic reamer, single-use

Phantom Hindfoot TTC/TC Nail System - 00889795130839

Screw Reamer, Large
Paragon 28, Inc.
P31-958-3001
In Commercial Distribution

  • 00889795130839 ()
P31-958-3001

  • Bone-resection orthopaedic reamer, single-use

Phantom Hindfoot TTC/TC Nail System - 00889795130822

Nail Trephine
Paragon 28, Inc.
P31-958-3000
In Commercial Distribution

  • 00889795130822 ()
P31-958-3000

  • Bone trephine, reusable

Phantom Hindfoot TTC/TC Nail System - 00889795130815

Calc Screw Easy Out
Paragon 28, Inc.
P31-958-0030
In Commercial Distribution

  • 00889795130815 ()
P31-958-0030

  • Orthopaedic inorganic implant inserter/extractor, single-use

Phantom Hindfoot TTC/TC Nail System - 00889795130808

Crossing Screw Easy Out
Paragon 28, Inc.
P31-958-0020
In Commercial Distribution

  • 00889795130808 ()
P31-958-0020

  • Orthopaedic inorganic implant inserter/extractor, single-use

Phantom Hindfoot TTC/TC Nail System - 00889795130792

End Cap Easy Out
Paragon 28, Inc.
P31-958-0010
In Commercial Distribution

  • 00889795130792 ()
P31-958-0010

  • Orthopaedic inorganic implant inserter/extractor, single-use

Phantom Hindfoot TTC/TC Nail System - 00889795130785

17mm Hex Nut
Paragon 28, Inc.
P31-958-1003
In Commercial Distribution

  • 00889795130785 ()
P31-958-1003

  • Surgical torque wrench, reusable

Phantom Hindfoot TTC/TC Nail System - 00889795130761

17mm Wrench
Paragon 28, Inc.
P31-958-1001
In Commercial Distribution

  • 00889795130761 ()
P31-958-1001

  • Surgical torque wrench, reusable

Phantom Hindfoot TTC/TC Nail System - 00889795130754

3.16th T-Handle Non-Ratcheting
Paragon 28, Inc.
P99-000-316C
In Commercial Distribution

  • 00889795130754 ()
P99-000-316C

  • Surgical instrument handle, torque-limiting

Monkey Rings™ External Fixation System - 00889795130457

Monkey Rings, Wire, Ø2.0mm x 500mm, Reduction, Half Point, Ti
Paragon 28, Inc.
P45-195-2140
In Commercial Distribution

  • 00889795130457 ()
P45-195-2140

  • External orthopaedic fixation system, single-use

Monkey Rings™ External Fixation System - 00889795130433

Monkey Rings, Wire, Ø1.8mm x 500mm, Reduction, Half Point
Paragon 28, Inc.
P45-195-1850
In Commercial Distribution

  • 00889795130433 ()
P45-195-1850

  • External orthopaedic fixation system, single-use

Monkey Rings™ External Fixation System - 00889795130419

Monkey Rings, Wire, Ø2.0mm x 500mm, Half Point
Paragon 28, Inc.
P45-194-2050
In Commercial Distribution

  • 00889795130419 ()
P45-194-2050

  • External orthopaedic fixation system, single-use

Monkey Rings™ External Fixation System - 00889795130402

Monkey Rings, Wire, Ø1.8mm x 500mm, Half Point
Paragon 28, Inc.
P45-194-1850
In Commercial Distribution

  • 00889795130402 ()
P45-194-1850

  • External orthopaedic fixation system, single-use

Monkey Rings™ External Fixation System - 00889795129635

Steinman Pin, Drill Tip, Ø4.0mm x 230mm, AO
Paragon 28, Inc.
P45-193-4030
In Commercial Distribution

  • 00889795129635 ()
P45-193-4030

  • External orthopaedic fixation system, single-use

Monkey Rings™ External Fixation System - 00889795129628

Steinman Pin, Drill Tip, Ø3.2mm x 230mm
Paragon 28, Inc.
P45-192-1032
In Commercial Distribution

  • 00889795129628 ()
P45-192-1032

  • External orthopaedic fixation system, single-use

Monkey Rings™ External Fixation System - 00889795129611

Steinman Pin, Drill Tip, Ø2.3mm x 230mm
Paragon 28, Inc.
P45-192-1023
In Commercial Distribution

  • 00889795129611 ()
P45-192-1023

  • External orthopaedic fixation system, single-use

Monkey Rings™ External Fixation System - 00889795129604

5/6 TAB CLOSURE RING, Ø220mm
Paragon 28, Inc.
P45-125-1220
In Commercial Distribution

  • 00889795129604 ()
P45-125-1220

  • External orthopaedic fixation system, single-use

Monkey Rings™ External Fixation System - 00889795129598

5/6 TAB CLOSURE RING, Ø200mm
Paragon 28, Inc.
P45-125-1200
In Commercial Distribution

  • 00889795129598 ()
P45-125-1200

  • External orthopaedic fixation system, single-use

Monkey Rings™ External Fixation System - 00889795129581

5/6 TAB CLOSURE RING, Ø180mm
Paragon 28, Inc.
P45-125-1180
In Commercial Distribution

  • 00889795129581 ()
P45-125-1180

  • External orthopaedic fixation system, single-use

Monkey Rings™ External Fixation System - 00889795129574

5/6 TAB CLOSURE RING, Ø160mm
Paragon 28, Inc.
P45-125-1160
In Commercial Distribution

  • 00889795129574 ()
P45-125-1160

  • External orthopaedic fixation system, single-use

Monkey Rings™ External Fixation System - 00889795129567

5/6 TAB CLOSURE RING, Ø140mm
Paragon 28, Inc.
P45-125-1140
In Commercial Distribution

  • 00889795129567 ()
P45-125-1140

  • External orthopaedic fixation system, single-use

Monkey Rings™ External Fixation System - 00889795129550

5/6 TAB CLOSURE RING, Ø120mm
Paragon 28, Inc.
P45-125-1120
In Commercial Distribution

  • 00889795129550 ()
P45-125-1120

  • External orthopaedic fixation system, single-use

Monkey Rings™ External Fixation System - 00889795129543

5/6 TAB RING, Ø220mm
Paragon 28, Inc.
P45-125-0220
In Commercial Distribution

  • 00889795129543 ()
P45-125-0220

  • External orthopaedic fixation system, single-use

Monkey Rings™ External Fixation System - 00889795129536

5/6 TAB RING, Ø200mm
Paragon 28, Inc.
P45-125-0200
In Commercial Distribution

  • 00889795129536 ()
P45-125-0200

  • External orthopaedic fixation system, single-use

Monkey Rings™ External Fixation System - 00889795129529

5/6 TAB RING, Ø180mm
Paragon 28, Inc.
P45-125-0180
In Commercial Distribution

  • 00889795129529 ()
P45-125-0180

  • External orthopaedic fixation system, single-use

Monkey Rings™ External Fixation System - 00889795129512

5/6 TAB RING, Ø160mm
Paragon 28, Inc.
P45-125-0160
In Commercial Distribution

  • 00889795129512 ()
P45-125-0160

  • External orthopaedic fixation system, single-use

Monkey Rings™ External Fixation System - 00889795129505

5/6 TAB RING, Ø140mm
Paragon 28, Inc.
P45-125-0140
In Commercial Distribution

  • 00889795129505 ()
P45-125-0140

  • External orthopaedic fixation system, single-use

Monkey Rings™ External Fixation System - 00889795129499

5/6 TAB RING, Ø120mm
Paragon 28, Inc.
P45-125-0120
In Commercial Distribution

  • 00889795129499 ()
P45-125-0120

  • External orthopaedic fixation system, single-use

Monkey Rings™ External Fixation System - 00889795129482

SHORT FOOT PLATE, Ø220mm
Paragon 28, Inc.
P45-141-0220
In Commercial Distribution

  • 00889795129482 ()
P45-141-0220

  • External orthopaedic fixation system, single-use

Monkey Rings™ External Fixation System - 00889795129475

SHORT FOOT PLATE, Ø200mm
Paragon 28, Inc.
P45-141-0200
In Commercial Distribution

  • 00889795129475 ()
P45-141-0200

  • External orthopaedic fixation system, single-use

Monkey Rings™ External Fixation System - 00889795129468

SHORT FOOT PLATE, Ø180mm
Paragon 28, Inc.
P45-141-0180
In Commercial Distribution

  • 00889795129468 ()
P45-141-0180

  • External orthopaedic fixation system, single-use

Monkey Rings™ External Fixation System - 00889795129451

SHORT FOOT PLATE, Ø160mm
Paragon 28, Inc.
P45-141-0160
In Commercial Distribution

  • 00889795129451 ()
P45-141-0160

  • External orthopaedic fixation system, single-use

Monkey Rings™ External Fixation System - 00889795129444

SHORT FOOT PLATE, Ø140mm
Paragon 28, Inc.
P45-141-0140
In Commercial Distribution

  • 00889795129444 ()
P45-141-0140

  • External orthopaedic fixation system, single-use

Monkey Rings™ External Fixation System - 00889795129437

SHORT FOOT PLATE, Ø120mm
Paragon 28, Inc.
P45-141-0120
In Commercial Distribution

  • 00889795129437 ()
P45-141-0120

  • External orthopaedic fixation system, single-use

Bun-Yo-Matic™ Lapidus Clamp System - 00889795129420

5mm Female Hex Driver
Paragon 28, Inc.
P99-150-FHX5
In Commercial Distribution

  • 00889795129420 ()
P99-150-FHX5

  • Surgical screwdriver, reusable

Bun-Yo-Matic™ Lapidus Clamp System - 00889795129413

Lapidus Nail Tissue Protector, Rotated 90
Paragon 28, Inc.
P30-100-5310
In Commercial Distribution

  • 00889795129413 ()
P30-100-5310

  • Orthopaedic implantation sleeve, reusable

Bun-Yo-Matic™ Lapidus Clamp System - 00889795129383

Bun-Yo-Matic, Lateral Adjuster, Left
Paragon 28, Inc.
P30-960-1202L
In Commercial Distribution

  • 00889795129383 ()
P30-960-1202L

  • Osteotomy guide, reusable

Bun-Yo-Matic™ Lapidus Clamp System - 00889795129352

Bun-Yo-Matic, Tray, Base
Paragon 28, Inc.
P30-CAD-0001
In Commercial Distribution

  • 00889795129352 ()
P30-CAD-0001

  • Device sterilization/disinfection container, reusable

Bun-Yo-Matic™ Lapidus Clamp System - 00889795129284

Bun-Yo-Matic, Met Grip Wire Guide
Paragon 28, Inc.
P30-960-1210
In Commercial Distribution

  • 00889795129284 ()
P30-960-1210

  • Osteotomy guide, reusable

Bun-Yo-Matic™ Lapidus Clamp System - 00889795129277

Bun-Yo-Matic, Wire Tube
Paragon 28, Inc.
P30-960-1208
In Commercial Distribution

  • 00889795129277 ()
P30-960-1208

  • Osteotomy guide, reusable

Bun-Yo-Matic™ Lapidus Clamp System - 00889795129260

Bun-Yo-Matic, 1st Met Wire Guide
Paragon 28, Inc.
P30-960-1207
In Commercial Distribution

  • 00889795129260 ()
P30-960-1207

  • Osteotomy guide, reusable

Bun-Yo-Matic™ Lapidus Clamp System - 00889795129215

Bun-Yo-Matic, Lateral Hook
Paragon 28, Inc.
P30-960-1203
In Commercial Distribution

  • 00889795129215 ()
P30-960-1203

  • Osteotomy guide, reusable

Bun-Yo-Matic™ Lapidus Clamp System - 00889795129208

Bun-Yo-Matic, Lateral Adjuster, Right
Paragon 28, Inc.
P30-960-1202R
In Commercial Distribution

  • 00889795129208 ()
P30-960-1202R

  • Osteotomy guide, reusable

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 - 00889795129161

Short Foot Rocker
Paragon 28, Inc.
P45-170-3000
In Commercial Distribution

  • 00889795129161 ()
P45-170-3000

  • External orthopaedic fixation system, single-use

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
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