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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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Monster Screw System - 00889795135124

Monster Hindfoot SL Instrument Caddy Base
Paragon 28, Inc.
P20-900-MH70-3
In Commercial Distribution

  • 00889795135124 ()
P20-900-MH70-3

  • Device sterilization/disinfection container, reusable

Monster Screw System - 00889795135117

Monster Hindfoot SL Implant Caddy Lid
Paragon 28, Inc.
P20-900-MH70-2
In Commercial Distribution

  • 00889795135117 ()
P20-900-MH70-2

  • Device sterilization/disinfection container, reusable

Monster Screw System - 00889795135100

Monster Hindfoot SL Implant Caddy Base
Paragon 28, Inc.
P20-900-MH70-1
In Commercial Distribution

  • 00889795135100 ()
P20-900-MH70-1

  • Device sterilization/disinfection container, reusable

Phantom® Fibula Nail System - 00889795135094

Phantom Fibula Nail System, Screw Caddy Lid
Paragon 28, Inc.
P36-900-SCWL
In Commercial Distribution

  • 00889795135094 ()
P36-900-SCWL

  • Device sterilization/disinfection container, reusable

Phantom® Fibula Nail System - 00889795135087

Phantom Fibula Nail System, Screw Caddy Base
Paragon 28, Inc.
P36-900-SCWB
In Commercial Distribution

  • 00889795135087 ()
P36-900-SCWB

  • Device sterilization/disinfection container, reusable

Phantom® Fibula Nail System - 00889795135070

Phantom Fibula Nail System, Case 1 of 1, Instrument Tray 2
Paragon 28, Inc.
P36-900-FIB2
In Commercial Distribution

  • 00889795135070 ()
P36-900-FIB2

  • Device sterilization/disinfection container, reusable

Phantom® Fibula Nail System - 00889795135063

Phantom Fibula Nail System, Case 1 of 1, Instrument Tray 1
Paragon 28, Inc.
P36-900-FIB1
In Commercial Distribution

  • 00889795135063 ()
P36-900-FIB1

  • Device sterilization/disinfection container, reusable

Phantom® Fibula Nail System - 00889795135056

Phantom Fibula Nail System, Case 1 of 1, Case Lid
Paragon 28, Inc.
P36-900-FIBL
In Commercial Distribution

  • 00889795135056 ()
P36-900-FIBL

  • Device sterilization/disinfection container, reusable

Phantom® Fibula Nail System - 00889795135049

Phantom Fibula Nail System, Case 1 of 1, Case Base
Paragon 28, Inc.
P36-900-FIBB
In Commercial Distribution

  • 00889795135049 ()
P36-900-FIBB

  • Device sterilization/disinfection container, reusable

Phantom® Fibula Nail System - 00889795135018

Easy-Out Removal Tool, Small, AO Quick Connect
Paragon 28, Inc.
P36-970-0003
In Commercial Distribution

  • 00889795135018 ()
P36-970-0003

  • Orthopaedic inorganic implant inserter/extractor, single-use

Phantom® Fibula Nail System - 00889795135001

Small Mallet
Paragon 28, Inc.
P36-970-0002
In Commercial Distribution

  • 00889795135001 ()
P36-970-0002

  • Surgical mallet

Phantom® Fibula Nail System - 00889795134998

Impaction Attachment
Paragon 28, Inc.
P36-970-0001
In Commercial Distribution

  • 00889795134998 ()
P36-970-0001

  • Orthopaedic implant impactor, reusable

Phantom® Fibula Nail System - 00889795134868

Dynamic Drill Sleeve
Paragon 28, Inc.
P36-955-4201
In Commercial Distribution

  • 00889795134868 ()
P36-955-4201

  • Orthopaedic implantation sleeve, reusable

Phantom® Fibula Nail System - 00889795134844

3.5mm Screw Sleeve
Paragon 28, Inc.
P36-955-3502
In Commercial Distribution

  • 00889795134844 ()
P36-955-3502

  • Orthopaedic implantation sleeve, reusable

Phantom® Fibula Nail System - 00889795134820

2.7mm Screw Sleeve
Paragon 28, Inc.
P36-955-2702
In Commercial Distribution

  • 00889795134820 ()
P36-955-2702

  • Orthopaedic implantation sleeve, reusable

Precision MIS Bunion System - 00889795132802

Countersink, Ø3.0 Screw
Paragon 28, Inc.
P27-940-0030
In Commercial Distribution

  • 00889795132802 ()
P27-940-0030

  • Surgical countersink, single-use

Precision MIS Bunion System - 00889795132796

Angel Wing
Paragon 28, Inc.
P27-920-ANWG
In Commercial Distribution

  • 00889795132796 ()
P27-920-ANWG

  • Orthopaedic prosthesis implantation positioning instrument, reusable

Precision MIS Bunion System - 00889795132789

Outrigger, Left
Paragon 28, Inc.
P27-101-100L
In Commercial Distribution

  • 00889795132789 ()
P27-101-100L

  • Orthopaedic prosthesis implantation positioning instrument, reusable

Precision MIS Bunion System - 00889795132772

Outrigger, Right
Paragon 28, Inc.
P27-101-100R
In Commercial Distribution

  • 00889795132772 ()
P27-101-100R

  • Orthopaedic prosthesis implantation positioning instrument, reusable

Precision MIS Bunion System - 00889795132765

Depth Gauge, Common
Paragon 28, Inc.
P27-951-3540
In Commercial Distribution

  • 00889795132765 ()
P27-951-3540

  • Surgical depth gauge, reusable

Precision MIS Bunion System - 00889795132758

Sterilization Container, K-wire, Outrigger Fixation
Paragon 28, Inc.
P27-193-OR10
In Commercial Distribution

  • 00889795132758 ()
P27-193-OR10

  • Device sterilization/disinfection container, reusable

Precision MIS Bunion System - 00889795132741

Sterilization Container for Ø1.7 x 230mm K-wire
Paragon 28, Inc.
P27-193-4023
In Commercial Distribution

  • 00889795132741 ()
P27-193-4023

  • Device sterilization/disinfection container, reusable

Precision MIS Bunion System - 00889795132734

Sterilization Container for Ø1.6 x 230mm K-wire
Paragon 28, Inc.
P27-193-3523
In Commercial Distribution

  • 00889795132734 ()
P27-193-3523

  • Device sterilization/disinfection container, reusable

Precision MIS Bunion System - 00889795132727

Sterilization Container for Ø1.2 x 230mm K-wire
Paragon 28, Inc.
P27-193-3023
In Commercial Distribution

  • 00889795132727 ()
P27-193-3023

  • Device sterilization/disinfection container, reusable

Precision MIS Bunion System - 00889795132710

Ø1.7 x 230mm Smooth K-wire for Ø4.0 Screw
Paragon 28, Inc.
P27-192-4023
In Commercial Distribution

  • 00889795132710 ()
P27-192-4023

  • Orthopaedic guidewire, single-use

Precision MIS Bunion System - 00889795132703

Ø1.6 x 230mm Smooth K-wire for Ø3.5 Screw
Paragon 28, Inc.
P27-192-3523
In Commercial Distribution

  • 00889795132703 ()
P27-192-3523

  • Orthopaedic guidewire, single-use

Precision MIS Bunion System - 00889795132697

Ø1.2 x 230mm Smooth K-wire for Ø3.0 Screw
Paragon 28, Inc.
P27-192-3023
In Commercial Distribution

  • 00889795132697 ()
P27-192-3023

  • Orthopaedic guidewire, single-use

Precision MIS Bunion System - 00889795132680

K-wire, 2.0mm x 100mm
Paragon 28, Inc.
P27-192-2010
In Commercial Distribution

  • 00889795132680 ()
P27-192-2010

  • Orthopaedic guidewire, single-use

Precision MIS Bunion System - 00889795132673

Ø4.0 Driver, Solid, Short
Paragon 28, Inc.
P27-191-TT40
In Commercial Distribution

  • 00889795132673 ()
P27-191-TT40

  • Surgical screwdriver, reusable

Precision MIS Bunion System - 00889795132666

Ø3.5 Driver, Solid, Short
Paragon 28, Inc.
P27-191-TT35
In Commercial Distribution

  • 00889795132666 ()
P27-191-TT35

  • Surgical screwdriver, reusable

Precision MIS Bunion System - 00889795132659

Ø3.0 Driver, Solid, Short
Paragon 28, Inc.
P27-191-TT30
In Commercial Distribution

  • 00889795132659 ()
P27-191-TT30

  • Surgical screwdriver, reusable

Precision MIS Bunion System - 00889795132642

Ø4.0 Driver, Cannulated, Short
Paragon 28, Inc.
P27-190-TS40
In Commercial Distribution

  • 00889795132642 ()
P27-190-TS40

  • Surgical screwdriver, reusable

Precision MIS Bunion System - 00889795132635

Ø3.5 Driver, Cannulated, Short
Paragon 28, Inc.
P27-190-TS35
In Commercial Distribution

  • 00889795132635 ()
P27-190-TS35

  • Surgical screwdriver, reusable

Precision MIS Bunion System - 00889795132628

Ø3.0 Driver, Cannulated, Short
Paragon 28, Inc.
P27-190-TS30
In Commercial Distribution

  • 00889795132628 ()
P27-190-TS30

  • Surgical screwdriver, reusable

Precision MIS Bunion System - 00889795132611

Ø4.0 Driver, Cannulated Long
Paragon 28, Inc.
P27-190-TL40
In Commercial Distribution

  • 00889795132611 ()
P27-190-TL40

  • Surgical screwdriver, reusable

Precision MIS Bunion System - 00889795132604

Ø3.5 Driver, Cannulated Long
Paragon 28, Inc.
P27-190-TL35
In Commercial Distribution

  • 00889795132604 ()
P27-190-TL35

  • Surgical screwdriver, reusable

Precision MIS Bunion System - 00889795132598

Ø3.0 Driver, Cannulated Long
Paragon 28, Inc.
P27-190-TL30
In Commercial Distribution

  • 00889795132598 ()
P27-190-TL30

  • Surgical screwdriver, reusable

Precision MIS Bunion System - 00889795132581

Ø3.0mm Cannulated Drill for Ø4.0 Screw, Short
Paragon 28, Inc.
P27-110-3012
In Commercial Distribution

  • 00889795132581 ()
P27-110-3012

  • Cannulated surgical drill bit, single-use

Precision MIS Bunion System - 00889795132574

Ø2.7mm Cannulated Drill for Ø3.5 Screw, Short
Paragon 28, Inc.
P27-110-2712
In Commercial Distribution

  • 00889795132574 ()
P27-110-2712

  • Cannulated surgical drill bit, single-use

Precision MIS Bunion System - 00889795132567

Ø2.4mm Cannulated Drill for Ø3.0 Screw, Short
Paragon 28, Inc.
P27-110-2412
In Commercial Distribution

  • 00889795132567 ()
P27-110-2412

  • Cannulated surgical drill bit, single-use

Precision MIS Bunion System - 00889795132550

Ø2.4mm Cannulated Drill for Ø3.0 Screw, Long
Paragon 28, Inc.
P27-110-2420
In Commercial Distribution

  • 00889795132550 ()
P27-110-2420

  • Cannulated surgical drill bit, single-use

Phantom Hindfoot TTC/TC Nail System - 00889795132499

Large Slap Hammer, Tip
Paragon 28, Inc.
P99-150-2005-06
In Commercial Distribution

  • 00889795132499 ()
P99-150-2005-06

  • Orthopaedic implantation hammering attachment

Baby Gorilla®/Gorilla® Plating System - 00889795132345

1/3 Tubular Plate, 2 Hole STERILE
Paragon 28, Inc.
P53-201-1002-S
In Commercial Distribution

  • 00889795132345 ()
P53-201-1002-S

  • Orthopaedic fixation plate, non-bioabsorbable

Grappler™ Suture Anchor System - 00889795132277

Grappler Suture Anchor, Titanium, ø3.0 x 12mm, Sterile Kit
Paragon 28, Inc.
P44-111-3012-SK
In Commercial Distribution

  • 00889795132277 ()
P44-111-3012-SK

  • General internal orthopaedic fixation system implantation kit

Monkey Rings™ External Fixation System - 00889795132246

Rapid Nut Wrench
Paragon 28, Inc.
P45-517-0002
In Commercial Distribution

  • 00889795132246 ()
P45-517-0002

  • Surgical torque wrench, reusable

Precision MIS Bunion System - 00889795132215

Precision MIS Screw, Cannulated, Ø4.0 x 68mm
Paragon 28, Inc.
P27-140-0068
In Commercial Distribution

  • 00889795132215 ()
P27-140-0068

  • Orthopaedic bone screw (non-sliding)

Precision MIS Bunion System - 00889795132192

Precision MIS Screw, Cannulated, Ø4.0 x 64mm
Paragon 28, Inc.
P27-140-0064
In Commercial Distribution

  • 00889795132192 ()
P27-140-0064

  • Orthopaedic bone screw (non-sliding)

Precision MIS Bunion System - 00889795132178

Precision MIS Screw, Cannulated, Ø4.0 x 60mm
Paragon 28, Inc.
P27-140-0060
In Commercial Distribution

  • 00889795132178 ()
P27-140-0060

  • Orthopaedic bone screw (non-sliding)

Precision MIS Bunion System - 00889795132154

Precision MIS Screw, Cannulated, Ø4.0 x 56mm
Paragon 28, Inc.
P27-140-0056
In Commercial Distribution

  • 00889795132154 ()
P27-140-0056

  • Orthopaedic bone screw (non-sliding)

Precision MIS Bunion System - 00889795132130

Precision MIS Screw, Cannulated, Ø4.0 x 52mm
Paragon 28, Inc.
P27-140-0052
In Commercial Distribution

  • 00889795132130 ()
P27-140-0052

  • Orthopaedic bone screw (non-sliding)
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