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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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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, Ø4.20 x 52mm
Paragon 28, Inc.
P50-453-4252
In Commercial Distribution

  • 00889795100542 ()
P50-453-4252

  • Orthopaedic bone screw, non-bioabsorbable, non-sterile
R3CON Non-Locking Screw, Ø4.20 x 45mm
Paragon 28, Inc.
P50-453-4245
In Commercial Distribution

  • 00889795100535 ()
P50-453-4245

  • Orthopaedic bone screw, non-bioabsorbable, non-sterile
R3CON Non-Locking Screw, Ø4.20 x 8mm
Paragon 28, Inc.
P50-453-4208
In Commercial Distribution

  • 00889795100528 ()
P50-453-4208

  • Orthopaedic bone screw, non-bioabsorbable, non-sterile
R3CON Locking Screw, Ø4.20 x 58mm
Paragon 28, Inc.
P50-353-4258
In Commercial Distribution

  • 00889795100511 ()
P50-353-4258

  • Orthopaedic bone screw, non-bioabsorbable, non-sterile
R3CON Locking Screw, Ø4.20 x 56mm
Paragon 28, Inc.
P50-353-4256
In Commercial Distribution

  • 00889795100504 ()
P50-353-4256

  • Orthopaedic bone screw, non-bioabsorbable, non-sterile
R3CON Locking Screw, Ø4.20 x 54mm
Paragon 28, Inc.
P50-353-4254
In Commercial Distribution

  • 00889795100498 ()
P50-353-4254

  • Orthopaedic bone screw, non-bioabsorbable, non-sterile
R3CON Locking Screw, Ø4.20 x 52mm
Paragon 28, Inc.
P50-353-4252
In Commercial Distribution

  • 00889795100481 ()
P50-353-4252

  • Orthopaedic bone screw, non-bioabsorbable, non-sterile
R3CON Locking Screw, Ø4.20 x 45mm
Paragon 28, Inc.
P50-353-4245
In Commercial Distribution

  • 00889795100474 ()
P50-353-4245

  • Orthopaedic bone screw, non-bioabsorbable, non-sterile
R3CON Locking Screw, Ø4.20 x 8mm
Paragon 28, Inc.
P50-353-4208
In Commercial Distribution

  • 00889795100467 ()
P50-353-4208

  • Orthopaedic bone screw, non-bioabsorbable, non-sterile
R3CON Non-Locking Screw, Ø3.50 x 58mm
Paragon 28, Inc.
P50-453-3558
In Commercial Distribution

  • 00889795100450 ()
P50-453-3558

  • Orthopaedic bone screw, non-bioabsorbable, non-sterile
R3CON Non-Locking Screw, Ø3.50 x 56mm
Paragon 28, Inc.
P50-453-3556
In Commercial Distribution

  • 00889795100443 ()
P50-453-3556

  • Orthopaedic bone screw, non-bioabsorbable, non-sterile
Gorilla, Ankle Fx., Anterolateral Distal Tibia Plate, Left, 25-Holes, TiA
Paragon 28, Inc.
P53-213-L018
In Commercial Distribution

  • 00889795099358 ()
P53-213-L018

  • Orthopaedic fixation plate, non-bioabsorbable, non-sterile
Gorilla, Ankle Fx., Anterolateral Distal Tibia Plate, Left, 23-Holes, TiA
Paragon 28, Inc.
P53-213-L016
In Commercial Distribution

  • 00889795099341 ()
P53-213-L016

  • Orthopaedic fixation plate, non-bioabsorbable, non-sterile
Gorilla, Ankle Fx., Anterolateral Distal Tibia Plate, Left, 21-Holes, TiA
Paragon 28, Inc.
P53-213-L014
In Commercial Distribution

  • 00889795099334 ()
P53-213-L014

  • Orthopaedic fixation plate, non-bioabsorbable, non-sterile
Gorilla, Ankle Fx., Anterolateral Distal Tibia Plate, Left, 19-Holes, TiA
Paragon 28, Inc.
P53-213-L012
In Commercial Distribution

  • 00889795099327 ()
P53-213-L012

  • Orthopaedic fixation plate, non-bioabsorbable, non-sterile
Gorilla, Ankle Fx., Anterolateral Distal Tibia Plate, Left, 17-Holes, TiA
Paragon 28, Inc.
P53-213-L010
In Commercial Distribution

  • 00889795099310 ()
P53-213-L010

  • Orthopaedic fixation plate, non-bioabsorbable, non-sterile
Gorilla, Ankle Fx., Anterolateral Distal Tibia Plate, Left, 15-Holes, TiA
Paragon 28, Inc.
P53-213-L008
In Commercial Distribution

  • 00889795099303 ()
P53-213-L008

  • Orthopaedic fixation plate, non-bioabsorbable, non-sterile
Gorilla, Ankle Fx., Anterolateral Distal Tibia Plate, Left, 13-Holes, TiA
Paragon 28, Inc.
P53-213-L006
In Commercial Distribution

  • 00889795099297 ()
P53-213-L006

  • Orthopaedic fixation plate, non-bioabsorbable, non-sterile
Gorilla, Ankle Fx., Anterolateral Distal Tibia Plate, Left, 11-Holes, TiA
Paragon 28, Inc.
P53-213-L004
In Commercial Distribution

  • 00889795099280 ()
P53-213-L004

  • Orthopaedic fixation plate, 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
Tissue Protector
Paragon 28, Inc.
P31-956-0001
In Commercial Distribution

  • 00889795097927 ()
P31-956-0001

  • Orthopaedic implantation sleeve, reusable
PRECISION® Parallel Offset Guide
Paragon 28, Inc.
P31-951-1000
In Commercial Distribution

  • 00889795097903 ()
P31-951-1000

  • Surgical drill guide, reusable
PRECISION® Guide Alignment Fin
Paragon 28, Inc.
P31-951-0103
In Commercial Distribution

  • 00889795097897 ()
P31-951-0103

  • Orthopaedic fixation implant alignment tool
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