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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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R3ACT Stabilization System - 00889795113788

R3ACT Suture Release Guide Tube
Paragon 28, Inc.
P80-940-3903
In Commercial Distribution

  • 00889795113788 ()
P80-940-3903

  • Orthopaedic fixation implant alignment tool

R3ACT Stabilization System - 00889795113771

Pilot Nose Drill Stop Tube, 17mm Depth
Paragon 28, Inc.
P80-930-32PN-17
In Commercial Distribution

  • 00889795113771 ()
P80-930-32PN-17

  • Cannulated surgical drill bit, reusable

R3ACT Stabilization System - 00889795113764

Pilot Nose Drill Stop Tube, 14mm Depth
Paragon 28, Inc.
P80-930-32PN-14
In Commercial Distribution

  • 00889795113764 ()
P80-930-32PN-14

  • Cannulated surgical drill bit, reusable

R3ACT Stabilization System - 00889795113757

R3ACT Removal Driver
Paragon 28, Inc.
P80-940-3904
In Commercial Distribution

  • 00889795113757 ()
P80-940-3904

  • Surgical screwdriver, reusable

R3ACT Stabilization System - 00889795113740

Ø0.90mm Drill Point K-Wire
Paragon 28, Inc.
P99-307-0910
In Commercial Distribution

  • 00889795113740 ()
P99-307-0910

  • Orthopaedic bone wire

R3ACT Stabilization System - 00889795113733

Torque Limiting Handle, 8 in.-lb., petite
Paragon 28, Inc.
P99-000-TQ08
In Commercial Distribution

  • 00889795113733 ()
P99-000-TQ08

  • Surgical instrument handle, torque-limiting

R3ACT Stabilization System - 00889795113726

Ø2.8mm Drill Cone Guide
Paragon 28, Inc.
P80-930-2800
In Commercial Distribution

  • 00889795113726 ()
P80-930-2800

  • Orthopaedic fixation implant alignment tool

R3ACT Stabilization System - 00889795113719

Ø3.2mm Solid Drill with Ø2.8mm Pilot Nose
Paragon 28, Inc.
P80-900-32PN
In Commercial Distribution

  • 00889795113719 ()
P80-900-32PN

  • Cannulated surgical drill bit, reusable

Baby Gorilla®/Gorilla® Plating System - 00889795113702

Ø1.60mm X 10cm Olive Wire, Threaded, 316 LVM
Paragon 28, Inc.
P99-251-1610
In Commercial Distribution

  • 00889795113702 ()
P99-251-1610

  • Orthopaedic bone wire

Baby Gorilla®/Gorilla® Plating System - 00889795113696

Ø1.60mm X 8cm Olive Wire, Threaded, 316 LVM
Paragon 28, Inc.
P99-251-1608
In Commercial Distribution

  • 00889795113696 ()
P99-251-1608

  • Orthopaedic bone wire

Baby Gorilla®/Gorilla® Plating System - 00889795113689

Ø2.0mm x 15cm Threaded, K-Wire
Paragon 28, Inc.
P99-193-2015
In Commercial Distribution

  • 00889795113689 ()
P99-193-2015

  • Orthopaedic bone wire

Baby Gorilla®/Gorilla® Plating System - 00889795113672

Gorilla, R3CON, Locking Screw, Compact Thread, Ø3.50 x 18mm
Paragon 28, Inc.
P50-753-3518
In Commercial Distribution

  • 00889795113672 ()
P50-753-3518

  • Orthopaedic bone screw, non-bioabsorbable, non-sterile

Baby Gorilla®/Gorilla® Plating System - 00889795113665

Gorilla, R3CON, Locking Screw, Compact Thread, Ø3.50 x 16mm
Paragon 28, Inc.
P50-753-3516
In Commercial Distribution

  • 00889795113665 ()
P50-753-3516

  • Orthopaedic bone screw, non-bioabsorbable, non-sterile

Baby Gorilla®/Gorilla® Plating System - 00889795113658

Gorilla, R3CON, Locking Screw, Compact Thread, Ø3.50 x 14mm
Paragon 28, Inc.
P50-753-3514
In Commercial Distribution

  • 00889795113658 ()
P50-753-3514

  • Orthopaedic bone screw, non-bioabsorbable, non-sterile

Baby Gorilla®/Gorilla® Plating System - 00889795113641

Gorilla, R3CON, Locking Screw, Compact Thread, Ø3.50 x 12mm
Paragon 28, Inc.
P50-753-3512
In Commercial Distribution

  • 00889795113641 ()
P50-753-3512

  • Orthopaedic bone screw, non-bioabsorbable, non-sterile

Baby Gorilla®/Gorilla® Plating System - 00889795113634

Gorilla, R3CON, Locking Screw, Compact Thread, Ø3.50 x 10mm
Paragon 28, Inc.
P50-753-3510
In Commercial Distribution

  • 00889795113634 ()
P50-753-3510

  • Orthopaedic bone screw, non-bioabsorbable, non-sterile

Baby Gorilla®/Gorilla® Plating System - 00889795113627

Gorilla, R3CON, Non-Locking Screw, Compact Thread, Ø3.50 x 18mm
Paragon 28, Inc.
P50-853-3518
In Commercial Distribution

  • 00889795113627 ()
P50-853-3518

  • Orthopaedic bone screw, non-bioabsorbable, non-sterile

Baby Gorilla®/Gorilla® Plating System - 00889795113610

Gorilla, R3CON, Non-Locking Screw, Compact Thread, Ø3.50 x 16mm
Paragon 28, Inc.
P50-853-3516
In Commercial Distribution

  • 00889795113610 ()
P50-853-3516

  • Orthopaedic bone screw, non-bioabsorbable, non-sterile

Baby Gorilla®/Gorilla® Plating System - 00889795113603

Gorilla, R3CON, Non-Locking Screw, Compact Thread, Ø3.50 x 14mm
Paragon 28, Inc.
P50-853-3514
In Commercial Distribution

  • 00889795113603 ()
P50-853-3514

  • Orthopaedic bone screw, non-bioabsorbable, non-sterile

Baby Gorilla®/Gorilla® Plating System - 00889795113597

Gorilla, R3CON, Non-Locking Screw, Compact Thread, Ø3.50 x 12mm
Paragon 28, Inc.
P50-853-3512
In Commercial Distribution

  • 00889795113597 ()
P50-853-3512

  • Orthopaedic bone screw, non-bioabsorbable, non-sterile

Baby Gorilla®/Gorilla® Plating System - 00889795113580

Gorilla, R3CON, Non-Locking Screw, Compact Thread, Ø3.50 x 10mm
Paragon 28, Inc.
P50-853-3510
In Commercial Distribution

  • 00889795113580 ()
P50-853-3510

  • Orthopaedic bone screw, non-bioabsorbable, non-sterile

APEX 3D Total Ankle Replacement System - 00889795113559

TOTAL ANKLE, INSTRUMENTS, AP DEPTH GAUGE, SIZE 5
Paragon 28, Inc.
P10-942-APD5
In Commercial Distribution

  • 00889795113559 ()
P10-942-APD5

  • Surgical depth gauge, reusable

APEX 3D Total Ankle Replacement System - 00889795113542

TOTAL ANKLE, INSTRUMENTS, AP DEPTH GAUGE, SIZE 4
Paragon 28, Inc.
P10-942-APD4
In Commercial Distribution

  • 00889795113542 ()
P10-942-APD4

  • Surgical depth gauge, reusable

APEX 3D Total Ankle Replacement System - 00889795113535

TOTAL ANKLE, INSTRUMENTS, AP DEPTH GAUGE, SIZE 3
Paragon 28, Inc.
P10-942-APD3
In Commercial Distribution

  • 00889795113535 ()
P10-942-APD3

  • Surgical depth gauge, reusable

APEX 3D Total Ankle Replacement System - 00889795113528

TOTAL ANKLE, INSTRUMENTS, AP DEPTH GAUGE, SIZE 2
Paragon 28, Inc.
P10-942-APD2
In Commercial Distribution

  • 00889795113528 ()
P10-942-APD2

  • Surgical depth gauge, reusable

APEX 3D Total Ankle Replacement System - 00889795113511

TOTAL ANKLE, INSTRUMENTS, AP DEPTH GAUGE, SIZE 1
Paragon 28, Inc.
P10-942-APD1
In Commercial Distribution

  • 00889795113511 ()
P10-942-APD1

  • Surgical depth gauge, reusable

Baby Gorilla®/Gorilla® Plating System - 00889795113337

Silverback Gorilla, Caddy Base, Span Plates
Paragon 28, Inc.
P50-900-SBSPN
In Commercial Distribution

  • 00889795113337 ()
P50-900-SBSPN

  • Device sterilization/disinfection container, reusable

Baby Gorilla®/Gorilla® Plating System - 00889795113320

Silverback Gorilla, Caddy Base, Straddle Plates
Paragon 28, Inc.
P50-900-SBNST
In Commercial Distribution

  • 00889795113320 ()
P50-900-SBNST

  • Device sterilization/disinfection container, reusable

Grappler™ Suture Anchor System - 00889795113313

Solid Drill, ø4.3mm x 10cm
Paragon 28, Inc.
P44-940-4310
In Commercial Distribution

  • 00889795113313 ()
P44-940-4310

  • Cannulated surgical drill bit, reusable

Grappler™ Suture Anchor System - 00889795113306

Solid Drill, ø3.5mm x 10cm
Paragon 28, Inc.
P44-940-3510
In Commercial Distribution

  • 00889795113306 ()
P44-940-3510

  • Cannulated surgical drill bit, reusable

APEX 3D Total Ankle Replacement System - 00889795112651

Malleable Ribbon Retractor, 6” X 3/8”
Paragon 28, Inc.
P99-158-0638
In Commercial Distribution

  • 00889795112651 ()
P99-158-0638

  • Hand-held surgical retractor, reusable

APEX 3D Total Ankle Replacement System - 00889795112644

Malleable Ribbon Retractor, 6” X 1/2”
Paragon 28, Inc.
P99-158-0650
In Commercial Distribution

  • 00889795112644 ()
P99-158-0650

  • Hand-held surgical retractor, reusable

Baby Gorilla®/Gorilla® Plating System - 00889795112583

P28, Percutaneous Depth Gauge, SS
Paragon 28, Inc.
P99-150-0112
In Commercial Distribution

  • 00889795112583 ()
P99-150-0112

  • Surgical depth gauge, reusable

Baby Gorilla®/Gorilla® Plating System - 00889795112576

Lamina Spreader
Paragon 28, Inc.
P99-150-0114
In Commercial Distribution

  • 00889795112576 ()
P99-150-0114

  • Hand-held surgical retractor, reusable

Baby Gorilla®/Gorilla® Plating System - 00889795112569

Large, Lobster Claw Clamp
Paragon 28, Inc.
P99-150-0113
In Commercial Distribution

  • 00889795112569 ()
P99-150-0113

  • Bone approximation clamp

Baby Gorilla®/Gorilla® Plating System - 00889795112552

Ankle Fracture 360, Ø4.0 Mini Monster Instrument Caddy, Base
Paragon 28, Inc.
P50-900-4MMC
In Commercial Distribution

  • 00889795112552 ()
P50-900-4MMC

  • Device sterilization/disinfection container, reusable

Baby Gorilla®/Gorilla® Plating System - 00889795112545

Gorilla, Caddy, General Lid
Paragon 28, Inc.
P50-900-GLID
In Commercial Distribution

  • 00889795112545 ()
P50-900-GLID

  • Device sterilization/disinfection container, reusable

Baby Gorilla®/Gorilla® Plating System - 00889795112538

Ankle Fracture 360, Wire Caddy, Base
Paragon 28, Inc.
P50-900-GKWC
In Commercial Distribution

  • 00889795112538 ()
P50-900-GKWC

  • Device sterilization/disinfection container, reusable

Baby Gorilla®/Gorilla® Plating System - 00889795112521

Gorilla, Full DIN, Caddy Tray
Paragon 28, Inc.
P50-900-4002-1
In Commercial Distribution

  • 00889795112521 ()
P50-900-4002-1

  • Device sterilization/disinfection container, reusable

Baby Gorilla®/Gorilla® Plating System - 00889795112514

Ankle Fracture 360 Implant Case, Base
Paragon 28, Inc.
P50-900-4002
In Commercial Distribution

  • 00889795112514 ()
P50-900-4002

  • Device sterilization/disinfection container, reusable

Baby Gorilla®/Gorilla® Plating System - 00889795112507

Ankle Fracture 360 Instrument , Tray 3
Paragon 28, Inc.
P50-900-4003-3
In Commercial Distribution

  • 00889795112507 ()
P50-900-4003-3

  • Device sterilization/disinfection container, reusable

Baby Gorilla®/Gorilla® Plating System - 00889795112491

Ankle Fracture 360 Instrument , Tray 2
Paragon 28, Inc.
P50-900-4003-2
In Commercial Distribution

  • 00889795112491 ()
P50-900-4003-2

  • Device sterilization/disinfection container, reusable

Baby Gorilla®/Gorilla® Plating System - 00889795112484

Ankle Fracture 360, Instrument, Tray 1
Paragon 28, Inc.
P50-900-4003-1
In Commercial Distribution

  • 00889795112484 ()
P50-900-4003-1

  • Device sterilization/disinfection container, reusable

Baby Gorilla®/Gorilla® Plating System - 00889795112477

Ankle Fracture 360 Instrument Case, Base
Paragon 28, Inc.
P50-900-4003
In Commercial Distribution

  • 00889795112477 ()
P50-900-4003

  • Device sterilization/disinfection container, reusable

Baby Gorilla®/Gorilla® Plating System - 00889795112460

Ankle Fracture 360, Screw Caddy, Lid
Paragon 28, Inc.
P50-900-0020-2
In Commercial Distribution

  • 00889795112460 ()
P50-900-0020-2

  • Device sterilization/disinfection container, reusable

Baby Gorilla®/Gorilla® Plating System - 00889795112453

Ankle Fracture 360, Screw Caddy, Base
Paragon 28, Inc.
P50-900-0020-1
In Commercial Distribution

  • 00889795112453 ()
P50-900-0020-1

  • Device sterilization/disinfection container, reusable

Baby Gorilla®/Gorilla® Plating System - 00889795112415

Anterior Mini-Open Plate, TT, Flat, Standard, Right, 06-Hole, TiA
Paragon 28, Inc.
P53-431-R201
In Commercial Distribution

  • 00889795112415 ()
P53-431-R201

  • Orthopaedic fixation plate, non-bioabsorbable, non-sterile

Baby Gorilla®/Gorilla® Plating System - 00889795112408

Anterior Mini-Open Plate, TT, Flat, Standard, Left, 06-Hole, TiA
Paragon 28, Inc.
P53-431-L201
In Commercial Distribution

  • 00889795112408 ()
P53-431-L201

  • Orthopaedic fixation plate, non-bioabsorbable, non-sterile

Baby Gorilla®/Gorilla® Plating System - 00889795112392

Anterior Mini-Open Plate, TT, Contoured, Standard, Right, 06-Hole, TiA
Paragon 28, Inc.
P53-431-R101
In Commercial Distribution

  • 00889795112392 ()
P53-431-R101

  • Orthopaedic fixation plate, non-bioabsorbable, non-sterile

Baby Gorilla®/Gorilla® Plating System - 00889795112385

Anterior Mini-Open Plate, TT, Contoured, Standard, Left, 06-Hole, TiA
Paragon 28, Inc.
P53-431-L101
In Commercial Distribution

  • 00889795112385 ()
P53-431-L101

  • Orthopaedic fixation plate, non-bioabsorbable, non-sterile
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