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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Gorilla, Depth Gauge, 90mm
Paragon 28, Inc.
P99-150-0111
In Commercial Distribution

  • 00889795107121 ()
P99-150-0111

  • Surgical depth gauge, reusable
Ø4.5/5.0 Driver, Cannulated
Paragon 28, Inc.
P41-941-4550
In Commercial Distribution

  • 00889795106315 ()
P41-941-4550

  • Fluted surgical drill bit, single-use
Gorilla, Ankle Fracture, Pilon Plate, Caddy
Paragon 28, Inc.
P50-900-AFPL-1
In Commercial Distribution

  • 00889795106308 ()
P50-900-AFPL-1

  • Device sterilization/disinfection container, reusable
2.4MM X 18CM, SS SOLID
Paragon 28, Inc.
P99-100-2418
In Commercial Distribution

  • 00889795106285 ()
P99-100-2418

  • Cannulated surgical drill bit, reusable
Ø4.2MM X14CM SOLID OVERDRILL
Paragon 28, Inc.
P99-100-4214
In Commercial Distribution

  • 00889795106261 ()
P99-100-4214

  • Cannulated surgical drill bit, reusable
Ø2.7MM X13 SOLID OVERDRIL
Paragon 28, Inc.
P99-100-2713
In Commercial Distribution

  • 00889795106247 ()
P99-100-2713

  • Cannulated surgical drill bit, reusable
Monster Bite Driver, Disposable Handle
Paragon 28, Inc.
P13-905-0001
In Commercial Distribution

  • 00889795106230 ()
P13-905-0001

  • Surgical screwdriver, reusable
Bone Forceps, Large, 200mm
Paragon 28, Inc.
P99-150-1013
In Commercial Distribution

  • 00889795105950 ()
P99-150-1013

  • Dressing/utility forceps, scissors-like, reusable
Plantar Plate, Suture Retreiver, Assembly
Paragon 28, Inc.
P13-905-1035
In Commercial Distribution

  • 00889795105905 ()
P13-905-1035

  • Orthopaedic inorganic implant inserter/extractor, reusable
ø1.40mm X 15cm Kirschner Wire, 316 LVM
Paragon 28, Inc.
P13-192-1415
In Commercial Distribution

  • 00889795103499 ()
P13-192-1415

  • Orthopaedic bone wire
Paratrooper Plantar Plate Weil Kit, Sterile
Paragon 28, Inc.
P13-000-WEIL-SK
In Commercial Distribution

  • 00889795103482 ()
P13-000-WEIL-SK

  • Suturing unit, single-use
Mini Monster 4.0 X 80mm Headed Screw, Long Thread
Paragon 28, Inc.
P20-140-080L
In Commercial Distribution

  • 00889795100795 ()
P20-140-080L

  • Orthopaedic bone screw, non-bioabsorbable, non-sterile
Mini Monster 4.0 X 75mm Headed Screw, Long Thread
Paragon 28, Inc.
P20-140-075L
In Commercial Distribution

  • 00889795100788 ()
P20-140-075L

  • Orthopaedic bone screw, non-bioabsorbable, non-sterile
Mini Monster 4.0 X 70mm Headed Screw, Long Thread
Paragon 28, Inc.
P20-140-070L
In Commercial Distribution

  • 00889795100771 ()
P20-140-070L

  • Orthopaedic bone screw, non-bioabsorbable, non-sterile
Mini Monster 4.0 X 65mm Headed Screw, Long Thread
Paragon 28, Inc.
P20-140-065L
In Commercial Distribution

  • 00889795100764 ()
P20-140-065L

  • Orthopaedic bone screw, non-bioabsorbable, non-sterile
Mini Monster 4.0 X 22mm Headed Screw, Long Thread
Paragon 28, Inc.
P20-140-022L
In Commercial Distribution

  • 00889795100597 ()
P20-140-022L

  • Orthopaedic bone screw, non-bioabsorbable, non-sterile
R3CON Non-Locking Screw, Ø4.20 x 58mm
Paragon 28, Inc.
P50-453-4258
In Commercial Distribution

  • 00889795100573 ()
P50-453-4258

  • Orthopaedic bone screw, non-bioabsorbable, non-sterile
R3CON Non-Locking Screw, Ø4.20 x 56mm
Paragon 28, Inc.
P50-453-4256
In Commercial Distribution

  • 00889795100566 ()
P50-453-4256

  • Orthopaedic bone screw, non-bioabsorbable, non-sterile
R3CON Non-Locking Screw, Ø4.20 x 54mm
Paragon 28, Inc.
P50-453-4254
In Commercial Distribution

  • 00889795100559 ()
P50-453-4254

  • Orthopaedic bone screw, non-bioabsorbable, non-sterile
R3CON Non-Locking Screw, Ø3.50 x 8mm
Paragon 28, Inc.
P50-453-3508
In Commercial Distribution

  • 00889795100405 ()
P50-453-3508

  • Orthopaedic bone screw, non-bioabsorbable, non-sterile
R3CON Locking Screw, Ø3.50 x 70mm
Paragon 28, Inc.
P50-353-3570
In Commercial Distribution

  • 00889795100399 ()
P50-353-3570

  • Orthopaedic bone screw, non-bioabsorbable, non-sterile
R3CON Locking Screw, Ø3.50 x 60mm
Paragon 28, Inc.
P50-353-3560
In Commercial Distribution

  • 00889795100375 ()
P50-353-3560

  • Orthopaedic bone screw, non-bioabsorbable, non-sterile
R3CON Locking Screw, Ø3.50 x 55mm
Paragon 28, Inc.
P50-353-3555
In Commercial Distribution

  • 00889795100344 ()
P50-353-3555

  • Orthopaedic bone screw, non-bioabsorbable, non-sterile
R3CON Locking Screw, Ø3.50 x 54mm
Paragon 28, Inc.
P50-353-3554
In Commercial Distribution

  • 00889795100337 ()
P50-353-3554

  • Orthopaedic bone screw, non-bioabsorbable, non-sterile
R3CON Locking Screw, Ø3.50 x 8mm
Paragon 28, Inc.
P50-353-3508
In Commercial Distribution

  • 00889795100306 ()
P50-353-3508

  • Orthopaedic bone screw, non-bioabsorbable, non-sterile
DECOUPLED TALAR RESECTION, +7MM (F), DUAL SHIM
Paragon 28, Inc.
P10-942-DT07
In Commercial Distribution

  • 00889795100290 ()
P10-942-DT07

  • Orthopaedic prosthesis implantation positioning instrument, reusable
DECOUPLED TALAR RESECTION, +6MM, DUAL SHIM
Paragon 28, Inc.
P10-942-DT06
In Commercial Distribution

  • 00889795100283 ()
P10-942-DT06

  • Orthopaedic prosthesis implantation positioning instrument, reusable
DECOUPLED TALAR RESECTION, +5MM, DUAL SHIM
Paragon 28, Inc.
P10-942-DT05
In Commercial Distribution

  • 00889795100276 ()
P10-942-DT05

  • Orthopaedic prosthesis implantation positioning instrument, reusable
DECOUPLED TALAR RESECTION, +4MM, DUAL SHIM
Paragon 28, Inc.
P10-942-DT04
In Commercial Distribution

  • 00889795100269 ()
P10-942-DT04

  • Orthopaedic prosthesis implantation positioning instrument, reusable
DECOUPLED TALAR RESECTION, +3MM (C), DUAL SHIM
Paragon 28, Inc.
P10-942-DT03
In Commercial Distribution

  • 00889795100252 ()
P10-942-DT03

  • Orthopaedic prosthesis implantation positioning instrument, reusable
DECOUPLED TALAR RESECTION, +2MM, DUAL SHIM
Paragon 28, Inc.
P10-942-DT02
In Commercial Distribution

  • 00889795100245 ()
P10-942-DT02

  • Orthopaedic prosthesis implantation positioning instrument, reusable
DECOUPLED TALAR RESECTION, +1MM, DUAL SHIM
Paragon 28, Inc.
P10-942-DT01
In Commercial Distribution

  • 00889795100238 ()
P10-942-DT01

  • Orthopaedic prosthesis implantation positioning instrument, reusable
Gorilla Half Height Caddy Tray, Full DIN (Insert)
Paragon 28, Inc.
P50-900-0011
In Commercial Distribution

  • 00889795100054 ()
P50-900-0011

  • Device sterilization/disinfection container, reusable
Gorilla Half Height Implant Base, Full DIN
Paragon 28, Inc.
P50-900-0010
In Commercial Distribution

  • 00889795100047 ()
P50-900-0010

  • Device sterilization/disinfection container, reusable
TenoTac Caddy Lid
Paragon 28, Inc.
P42-900-TTAC-2
In Commercial Distribution

  • 00889795100023 ()
P42-900-TTAC-2

  • Device sterilization/disinfection container, reusable
TenoTac Caddy Base
Paragon 28, Inc.
P42-900-TTAC-1
In Commercial Distribution

  • 00889795100016 ()
P42-900-TTAC-1

  • Device sterilization/disinfection container, reusable
Monster 7.0mm Combination Headed and Headless Caddy, Base
Paragon 28, Inc.
P20-900-0010-1
In Commercial Distribution

  • 00889795099839 ()
P20-900-0010-1

  • Device sterilization/disinfection container, reusable
Driver, HX10, Ankle Fx. 360
Paragon 28, Inc.
P99-191-AF10
In Commercial Distribution

  • 00889795099778 ()
P99-191-AF10

  • Surgical screwdriver, reusable
Gorilla R3CON, Drill Guide, 2.7 Threaded, Locking, SS, Long
Paragon 28, Inc.
P51-900-1004
In Commercial Distribution

  • 00889795099723 ()
P51-900-1004

  • Orthopaedic implantation sleeve, reusable
R3CON Non-Locking Screw, Ø3.50 x 90mm
Paragon 28, Inc.
P50-453-3590
In Commercial Distribution

  • 00889795099716 ()
P50-453-3590

  • Orthopaedic bone screw, non-bioabsorbable, non-sterile
Gorilla®, R3CON™ Screw, Ø2.7 x 58mm, Non-Locking, Solid, TiA
Paragon 28, Inc.
P50-453-2758
In Commercial Distribution

  • 00889795099679 ()
P50-453-2758

  • Orthopaedic bone screw (non-sliding)
Gorilla®, R3CON™ Screw, Ø2.7 x 56mm, Non-Locking, Solid, TiA
Paragon 28, Inc.
P50-453-2756
In Commercial Distribution

  • 00889795099662 ()
P50-453-2756

  • Orthopaedic bone screw (non-sliding)
R3CON Locking Screw Ø2.70 x 48mm
Paragon 28, Inc.
P50-353-2748
In Commercial Distribution

  • 00889795099488 ()
P50-353-2748

  • Orthopaedic bone screw, non-bioabsorbable, non-sterile
R3CON Locking Screw, Ø2.70 x 42mm
Paragon 28, Inc.
P50-353-2742
In Commercial Distribution

  • 00889795099433 ()
P50-353-2742

  • Orthopaedic bone screw, non-bioabsorbable, non-sterile
Gorilla, Ankle Fx., Anterolateral Distal Tibia Plate, Right, 25-Holes, TiA
Paragon 28, Inc.
P53-213-R018
In Commercial Distribution

  • 00889795099273 ()
P53-213-R018

  • Orthopaedic fixation plate, non-bioabsorbable, non-sterile
Gorilla, Ankle Fx., Anterolateral Distal Tibia Plate, Right, 23-Holes, TiA
Paragon 28, Inc.
P53-213-R016
In Commercial Distribution

  • 00889795099266 ()
P53-213-R016

  • Orthopaedic fixation plate, non-bioabsorbable, non-sterile
Gorilla, Ankle Fx., Anterolateral Distal Tibia Plate, Right, 21-Holes, TiA
Paragon 28, Inc.
P53-213-R014
In Commercial Distribution

  • 00889795099259 ()
P53-213-R014

  • Orthopaedic fixation plate, non-bioabsorbable, non-sterile
Gorilla, Ankle Fx., Anterolateral Distal Tibia Plate, Right, 19-Holes, TiA
Paragon 28, Inc.
P53-213-R012
In Commercial Distribution

  • 00889795099242 ()
P53-213-R012

  • Orthopaedic fixation plate, non-bioabsorbable, non-sterile
Gorilla, Ankle Fx., Anterolateral Distal Tibia Plate, Right, 17-Holes, TiA
Paragon 28, Inc.
P53-213-R010
In Commercial Distribution

  • 00889795099235 ()
P53-213-R010

  • Orthopaedic fixation plate, non-bioabsorbable, non-sterile
Gorilla, Ankle Fx., Anterolateral Distal Tibia Plate, Right, 15-Holes, TiA
Paragon 28, Inc.
P53-213-R008
In Commercial Distribution

  • 00889795099228 ()
P53-213-R008

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