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 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
PRECISION® Guide Tube
Paragon 28, Inc.
P31-951-0102
In Commercial Distribution

  • 00889795097880 ()
P31-951-0102

  • Orthopaedic implant aiming arm
PRECISION® Guide Arm
Paragon 28, Inc.
P31-951-0101
In Commercial Distribution

  • 00889795097873 ()
P31-951-0101

  • Orthopaedic implant aiming arm
PRECISION® Guide Sphere Wire
Paragon 28, Inc.
P31-951-0199
In Commercial Distribution

  • 00889795097866 ()
P31-951-0199

  • Orthopaedic guidewire, single-use
PRECISION® Guide Drill Pin, 3.0 X 320mm
Paragon 28, Inc.
P31-951-3032
In Commercial Distribution

  • 00889795097859 ()
P31-951-3032

  • Orthopaedic guidewire, single-use
Wire Tube, Cap
Paragon 28, Inc.
P31-941-0000
In Commercial Distribution

  • 00889795097842 ()
P31-941-0000

  • Device sterilization/disinfection container, reusable
Wire Tube, 3.0 x 320mm
Paragon 28, Inc.
P31-941-0340
In Commercial Distribution

  • 00889795097835 ()
P31-941-0340

  • Device sterilization/disinfection container, reusable
Wire Tube, 2.3 x 300mm
Paragon 28, Inc.
P31-941-0320
In Commercial Distribution

  • 00889795097828 ()
P31-941-0320

  • Device sterilization/disinfection container, reusable
Wire Tube, 2.0 x 200mm
Paragon 28, Inc.
P31-941-0200
In Commercial Distribution

  • 00889795097811 ()
P31-941-0200

  • Device sterilization/disinfection container, reusable
Phantom ActivCore Nail, 13.0 X 250mm
Paragon 28, Inc.
P31-130-2500-S
In Commercial Distribution

  • 00889795097804 ()
P31-130-2500-S

  • Arthrodesis intramedullary nail, non-distracting
Phantom ActivCore Nail, 13.0 X 200mm
Paragon 28, Inc.
P31-130-2000-S
In Commercial Distribution

  • 00889795097798 ()
P31-130-2000-S

  • Arthrodesis intramedullary nail, non-distracting
Phantom ActivCore Nail, 13.0 X 175mm
Paragon 28, Inc.
P31-130-1750-S
In Commercial Distribution

  • 00889795097781 ()
P31-130-1750-S

  • Arthrodesis intramedullary nail, non-distracting
Phantom ActivCore Nail, 11.5 X 300mm
Paragon 28, Inc.
P31-115-3000-S
In Commercial Distribution

  • 00889795097774 ()
P31-115-3000-S

  • Arthrodesis intramedullary nail, non-distracting
Phantom ActivCore Nail, 11.5 X 250mm
Paragon 28, Inc.
P31-115-2500-S
In Commercial Distribution

  • 00889795097767 ()
P31-115-2500-S

  • Arthrodesis intramedullary nail, non-distracting
Phantom ActivCore Nail, 11.5 X 200mm
Paragon 28, Inc.
P31-115-2000-S
In Commercial Distribution

  • 00889795097750 ()
P31-115-2000-S

  • Arthrodesis intramedullary nail, non-distracting
Phantom ActivCore Nail, 11.5 X 175mm
Paragon 28, Inc.
P31-115-1750-S
In Commercial Distribution

  • 00889795097743 ()
P31-115-1750-S

  • Arthrodesis intramedullary nail, non-distracting
Phantom ActivCore Nail, 10.0 X 300mm
Paragon 28, Inc.
P31-102-3000-S
In Commercial Distribution

  • 00889795097736 ()
P31-102-3000-S

  • Arthrodesis intramedullary nail, non-distracting
Phantom ActivCore Nail, 10.0 X 200mm
Paragon 28, Inc.
P31-102-2000-S
In Commercial Distribution

  • 00889795097712 ()
P31-102-2000-S

  • Arthrodesis intramedullary nail, non-distracting
Phantom TC Nail, 13.0 X 250mm
Paragon 28, Inc.
P31-430-2500-S
In Commercial Distribution

  • 00889795097699 ()
P31-430-2500-S

  • Arthrodesis intramedullary nail, non-distracting
Phantom TC Nail, 13.0 X 175mm
Paragon 28, Inc.
P31-430-1750-S
In Commercial Distribution

  • 00889795097675 ()
P31-430-1750-S

  • Arthrodesis intramedullary nail, non-distracting
Phantom TC Nail, 11.5 X 200mm
Paragon 28, Inc.
P31-415-2000-S
In Commercial Distribution

  • 00889795097637 ()
P31-415-2000-S

  • Arthrodesis intramedullary nail, non-distracting
Phantom TC Nail, 11.5 X 150mm
Paragon 28, Inc.
P31-415-1500-S
In Commercial Distribution

  • 00889795097620 ()
P31-415-1500-S

  • Arthrodesis intramedullary nail, non-distracting
Phantom TC Nail, 10.0 X 300mm
Paragon 28, Inc.
P31-400-3000-S
In Commercial Distribution

  • 00889795097613 ()
P31-400-3000-S

  • Arthrodesis intramedullary nail, non-distracting
Phantom TC Nail, 10.0 X 200mm
Paragon 28, Inc.
P31-400-2000-S
In Commercial Distribution

  • 00889795097590 ()
P31-400-2000-S

  • Arthrodesis intramedullary nail, non-distracting
Phantom TC Nail, 10.0 X 150mm
Paragon 28, Inc.
P31-400-1500-S
In Commercial Distribution

  • 00889795097583 ()
P31-400-1500-S

  • Arthrodesis intramedullary nail, non-distracting
AVITRAC™ Core, MTP Reamer, Ø13 mm, STERILE
Paragon 28, Inc.
P01-901-1301-S
In Commercial Distribution

  • 00889795097576 ()
P01-901-1301-S

  • Bone-resection orthopaedic reamer, single-use
AVITRAC™ Core, MTP Reamer, Ø11 mm, STERILE
Paragon 28, Inc.
P01-901-1101-S
In Commercial Distribution

  • 00889795097569 ()
P01-901-1101-S

  • Bone-resection orthopaedic reamer, single-use
AVITRAC™ Core, MTP Reamer, Ø9 mm, STERILE
Paragon 28, Inc.
P01-901-0901-S
In Commercial Distribution

  • 00889795097552 ()
P01-901-0901-S

  • Bone-resection orthopaedic reamer, single-use
General Instrument, Lamina Spreader
Paragon 28, Inc.
P99-150-0030
In Commercial Distribution

  • 00889795097545 ()
P99-150-0030

  • Hand-held surgical retractor, reusable
APEX 3D™ Tibia, Flat, Right, Size 6, Standard, 3DP
Paragon 28, Inc.
P10-101-BR6S-S
In Commercial Distribution

  • 00889795097538 ()
P10-101-BR6S-S

  • Fixed-bearing total ankle prosthesis
APEX 3D™ Tibia, Flat, Left, Size 6, Standard, 3DP
Paragon 28, Inc.
P10-101-BL6S-S
In Commercial Distribution

  • 00889795097521 ()
P10-101-BL6S-S

  • Fixed-bearing total ankle prosthesis
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