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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 - 00889795130921

Vice Grips
Paragon 28, Inc.
P99-150-2008
In Commercial Distribution

  • 00889795130921 ()
P99-150-2008

  • Surgical vice grip

Phantom Hindfoot TTC/TC Nail System - 00889795130914

U Handle
Paragon 28, Inc.
P99-150-2007
In Commercial Distribution

  • 00889795130914 ()
P99-150-2007

  • Surgical instrument handle, torque-limiting

Phantom Hindfoot TTC/TC Nail System - 00889795130891

3/16th Adapter
Paragon 28, Inc.
P99-000-316B
In Commercial Distribution

  • 00889795130891 ()
P99-000-316B

  • Surgical screwdriver, reusable

Phantom Hindfoot TTC/TC Nail System - 00889795130884

Screw Remover, Small
Paragon 28, Inc.
P31-958-3013
In Commercial Distribution

  • 00889795130884 ()
P31-958-3013

  • Bone-resection orthopaedic reamer, single-use

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

Phantom Hindfoot TTC/TC Nail System - 00889795130747

Extender
Paragon 28, Inc.
P31-958-0007
In Commercial Distribution

  • 00889795130747 ()
P31-958-0007

  • Orthopaedic inorganic implant inserter/extractor, reusable

Phantom Hindfoot TTC/TC Nail System - 00889795130730

Nail Extraction Hook
Paragon 28, Inc.
P31-958-0005
In Commercial Distribution

  • 00889795130730 ()
P31-958-0005

  • Orthopaedic inorganic implant inserter/extractor, single-use

Phantom Hindfoot TTC/TC Nail System - 00889795130723

Conical Remover
Paragon 28, Inc.
P31-958-0004
In Commercial Distribution

  • 00889795130723 ()
P31-958-0004

  • Orthopaedic inorganic implant inserter/extractor, single-use

Phantom Hindfoot TTC/TC Nail System - 00889795130716

Extractor body
Paragon 28, Inc.
P31-958-0008
In Commercial Distribution

  • 00889795130716 ()
P31-958-0008

  • Orthopaedic inorganic implant inserter/extractor, reusable

Phantom Hindfoot TTC/TC Nail System - 00889795130709

Extractor Tip 2 – ActivCore Inner Nail Removal
Paragon 28, Inc.
P31-958-0003
In Commercial Distribution

  • 00889795130709 ()
P31-958-0003

  • Orthopaedic inorganic implant inserter/extractor, single-use

Phantom Hindfoot TTC/TC Nail System - 00889795130693

Extractor Tip 1 – Nail Removal
Paragon 28, Inc.
P31-958-0002
In Commercial Distribution

  • 00889795130693 ()
P31-958-0002

  • Orthopaedic inorganic implant inserter/extractor, single-use

Phantom Hindfoot TTC/TC Nail System - 00889795130686

Explant Attachment 2.0 TTC Only
Paragon 28, Inc.
P31-958-2001
In Commercial Distribution

  • 00889795130686 ()
P31-958-2001

  • Orthopaedic inorganic implant inserter/extractor, single-use

Phantom Hindfoot TTC/TC Nail System - 00889795130679

Large Slap Hammer
Paragon 28, Inc.
P99-150-2005
In Commercial Distribution

  • 00889795130679 ()
P99-150-2005

  • Orthopaedic implantation hammering attachment

JAWS® Nitinol Staple System - 00889795130655

JAWS Staple, 12mm, 12 x 12 Straight
Paragon 28, Inc.
P71-012-1212-S
In Commercial Distribution

  • 00889795130655 ()
P71-012-1212-S

  • Orthopaedic bone staple, non-adjustable

APEX 3D Total Ankle Replacement System - 00889795130648

Total Ankle Instrument, Right Angle Drill, Ø4.15 Bit
Paragon 28, Inc.
P10-854-RAD1-5
In Commercial Distribution

  • 00889795130648 ()
P10-854-RAD1-5

  • Fluted surgical drill bit, reusable

APEX 3D Total Ankle Replacement System - 00889795130631

Total Ankle, Instrument, Right Angle Drill, Left
Paragon 28, Inc.
P10-854-RAD2
In Commercial Distribution

  • 00889795130631 ()
P10-854-RAD2

  • Fluted surgical drill bit, reusable

APEX 3D Total Ankle Replacement System - 00889795130624

Total Ankle, Instrument, Right Angle Drill, Right
Paragon 28, Inc.
P10-854-RAD1
In Commercial Distribution

  • 00889795130624 ()
P10-854-RAD1

  • Fluted surgical drill bit, reusable

Baby Gorilla/Gorilla Plating System - 00889795130617

MTP Top Tray
Paragon 28, Inc.
P50-900-MTPT
In Commercial Distribution

  • 00889795130617 ()
P50-900-MTPT

  • Device sterilization/disinfection container, reusable

Baby Gorilla/Gorilla Plating System - 00889795130600

MTP Implant Case with R3CON Screws
Paragon 28, Inc.
P50-900-MTPS
In Commercial Distribution

  • 00889795130600 ()
P50-900-MTPS

  • Device sterilization/disinfection container, reusable

Baby Gorilla/Gorilla Plating System - 00889795130594

MTP Plate Tray
Paragon 28, Inc.
P50-900-MTPP
In Commercial Distribution

  • 00889795130594 ()
P50-900-MTPP

  • Device sterilization/disinfection container, reusable

Baby Gorilla/Gorilla Plating System - 00889795130587

MTP Instrument Case Lid
Paragon 28, Inc.
P50-900-MTPL-03
In Commercial Distribution

  • 00889795130587 ()
P50-900-MTPL-03

  • Device sterilization/disinfection container, reusable

Baby Gorilla/Gorilla Plating System - 00889795130570

MTP Plate Tray Lid
Paragon 28, Inc.
P50-900-MTPL-02
In Commercial Distribution

  • 00889795130570 ()
P50-900-MTPL-02

  • Device sterilization/disinfection container, reusable

Baby Gorilla/Gorilla Plating System - 00889795130563

MTP Implant Case Lid
Paragon 28, Inc.
P50-900-MTPL-01
In Commercial Distribution

  • 00889795130563 ()
P50-900-MTPL-01

  • Device sterilization/disinfection container, reusable

Baby Gorilla/Gorilla Plating System - 00889795130556

MTP Instrument Case Base
Paragon 28, Inc.
P50-900-MTPB
In Commercial Distribution

  • 00889795130556 ()
P50-900-MTPB

  • Device sterilization/disinfection container, reusable

Monkey Rings™ External Fixation System - 00889795130549

Patient Positioner Assembly
Paragon 28, Inc.
P45-980-0000
In Commercial Distribution

  • 00889795130549 ()
P45-980-0000

  • Orthopaedic prosthesis implantation positioning instrument, reusable

Monkey Rings™ External Fixation System - 00889795130532

Patient Positioner Platform
Paragon 28, Inc.
P45-980-0009
In Commercial Distribution

  • 00889795130532 ()
P45-980-0009

  • Orthopaedic prosthesis implantation positioning instrument, reusable

Monkey Rings™ External Fixation System - 00889795130525

Patient Positioner Craddle
Paragon 28, Inc.
P45-980-0001
In Commercial Distribution

  • 00889795130525 ()
P45-980-0001

  • Orthopaedic prosthesis implantation positioning instrument, reusable

Monkey Rings™ External Fixation System - 00889795130471

Rancho Cube, Post, 1 Hole
Paragon 28, Inc.
P45-926-0001
In Commercial Distribution

  • 00889795130471 ()
P45-926-0001

  • External orthopaedic fixation system, single-use

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
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