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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 - 00889795056733

ThorHammer
Paragon 28, Inc.
P99-150-2001
In Commercial Distribution

  • 00889795056733 ()
P99-150-2001

  • Surgical mallet

Monster Screw System - 00889795056719

1.2 X 150 Mm K Wire, Single Ended Trocar Tip, Threaded
Paragon 28, Inc.
P99-193-1215
In Commercial Distribution

  • 00889795056719 ()
P99-193-1215

  • Orthopaedic bone wire

Baby Gorilla/Gorilla Plating System - 00889795056702

Shannon-Style Bone Burr, 3.0mm
Paragon 28, Inc.
P99-105-3080-S
In Commercial Distribution

  • 00889795056702 ()
P99-105-3080-S

  • Orthopaedic bur, single-use

JAWS Nitinol Staple System - 00889795056696

Compressor
Paragon 28, Inc.
P99-150-0089
In Commercial Distribution

  • 00889795056696 ()
P99-150-0089

  • Orthopaedic fixation implant alignment tool

Baby Gorilla/Gorilla Plating System - 00889795056689

Bone Graft Harvester Caddy
Paragon 28, Inc.
P99-900-HARV
In Commercial Distribution

  • 00889795056689 ()
P99-900-HARV

  • Device sterilization/disinfection container, reusable

Baby Gorilla/Gorilla Plating System - 00889795056672

K-Wire, Single Ended Trocar Tip, Threaded, 2.5 x 150mm
Paragon 28, Inc.
P99-193-2515
In Commercial Distribution

  • 00889795056672 ()
P99-193-2515

  • Orthopaedic bone wire

Baby Gorilla/Gorilla Plating System - 00889795056665

Caspar Type Compression/Distraction Device
Paragon 28, Inc.
P99-150-0011-R
In Commercial Distribution

  • 00889795056665 ()
P99-150-0011-R

  • Osteotomy compression/distraction instrument

Baby Gorilla/Gorilla Plating System - 00889795056641

Lobster Claw, Closed
Paragon 28, Inc.
P99-150-T017
In Commercial Distribution

  • 00889795056641 ()
P99-150-T017

  • Bone holding forceps

Baby Gorilla/Gorilla Plating System - 00889795056634

R3LEASE Device, 3.9 X 48mm, 17mm Notch
Paragon 28, Inc.
P80-239-1748
In Commercial Distribution

  • 00889795056634 ()
P80-239-1748

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

Baby Gorilla/Gorilla Plating System - 00889795056627

R3LEASE Device, 3.9 X 48mm, 14mm Notch
Paragon 28, Inc.
P80-239-1448
In Commercial Distribution

  • 00889795056627 ()
P80-239-1448

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

Baby Gorilla®/Gorilla® Plating System - 00889795056450

Anterior Plates, Ball Tip Wire Guide
Paragon 28, Inc.
P51-980-5005
In Commercial Distribution

  • 00889795056450 ()
P51-980-5005

  • Orthopaedic prosthesis implantation positioning instrument, reusable

Baby Gorilla/Gorilla Plating System - 00889795056443

Gorilla R3con Drill Guide, Off Axis
Paragon 28, Inc.
P51-901-3102
In Commercial Distribution

  • 00889795056443 ()
P51-901-3102

  • Surgical drill guide, reusable

Baby Gorilla/Gorilla Plating System - 00889795056436

Gorilla R3con Drill Guide, Easy Guide, 2.7/3.5
Paragon 28, Inc.
P51-901-3101
In Commercial Distribution

  • 00889795056436 ()
P51-901-3101

  • Surgical drill guide, reusable

Baby Gorilla/Gorilla Plating System - 00889795056429

Gorilla R3con Drill Guide, 4.2 MM
Paragon 28, Inc.
P51-901-3142
In Commercial Distribution

  • 00889795056429 ()
P51-901-3142

  • Surgical drill guide, reusable

Baby Gorilla/Gorilla Plating System - 00889795056412

Centering Drill Guide 3.5mm, TUFFNEK
Paragon 28, Inc.
P51-902-1002-T
In Commercial Distribution

  • 00889795056412 ()
P51-902-1002-T

  • Surgical drill guide, reusable

Baby Gorilla/Gorilla Plating System - 00889795056405

Centering Drill Guide 4.2mm, TUFFNEK
Paragon 28, Inc.
P51-902-1003-T
In Commercial Distribution

  • 00889795056405 ()
P51-902-1003-T

  • Surgical drill guide, reusable

Baby Gorilla/Gorilla Plating System - 00889795056399

Gorilla R3con Drill Guide, Off Axis
Paragon 28, Inc.
P51-901-1101
In Commercial Distribution

  • 00889795056399 ()
P51-901-1101

  • Surgical drill guide, reusable

Baby Gorilla/Gorilla Plating System - 00889795056382

PROMO Cutting Jig
Paragon 28, Inc.
P51-908-0008
In Commercial Distribution

  • 00889795056382 ()
P51-908-0008

  • Osteotomy guide, reusable

Baby Gorilla/Gorilla Plating System - 00889795056375

Ø5.5mm Tissue Protector, Lateral Column Fusion
Paragon 28, Inc.
P51-924-0005
In Commercial Distribution

  • 00889795056375 ()
P51-924-0005

  • Orthopaedic implantation sleeve, reusable

Baby Gorilla/Gorilla Plating System - 00889795056368

Baby Gorilla, Implant Caddy Lid, Mini
Paragon 28, Inc.
P51-900-MNCL
In Commercial Distribution

  • 00889795056368 ()
P51-900-MNCL

  • Device sterilization/disinfection container, reusable
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