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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 - 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
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