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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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APEX 3D-PS Total Ankle Replacement System, Talus Trialing, Tray
Paragon 28, Inc.
P10-900-0004
In Commercial Distribution

  • 00889795098986 ()
P10-900-0004

  • Device sterilization/disinfection container, reusable
APEX 3D-PS Total Ankle Replacement System, Tibia Trialing, Tray
Paragon 28, Inc.
P10-900-0003
In Commercial Distribution

  • 00889795098979 ()
P10-900-0003

  • Device sterilization/disinfection container, reusable
APEX 3D-PS Total Ankle Replacement System, Resection, Tray
Paragon 28, Inc.
P10-900-0002
In Commercial Distribution

  • 00889795098962 ()
P10-900-0002

  • Device sterilization/disinfection container, reusable
APEX 3D-PS Total Ankle Replacement System, Poly Insertion Tool
Paragon 28, Inc.
P10-951-IN02
In Commercial Distribution

  • 00889795098931 ()
P10-951-IN02

  • Orthopaedic inorganic implant inserter/extractor, reusable
Dynamic Syndesmosis Screw Ø4.2 X 60mm, 17mm Notch, Sterile
Paragon 28, Inc.
P80-142-1760-S
In Commercial Distribution

  • 00889795098481 ()
P80-142-1760-S

  • Internal orthopaedic fixation system, plate/screw, non-bioabsorbable, sterile
Dynamic Syndesmosis Screw Ø4.2 X 50mm, 17mm Notch, Sterile
Paragon 28, Inc.
P80-142-1750-S
In Commercial Distribution

  • 00889795098467 ()
P80-142-1750-S

  • Internal orthopaedic fixation system, plate/screw, non-bioabsorbable, sterile
Dynamic Syndesmosis Screw Ø4.2 X 45mm, 17mm Notch, Sterile
Paragon 28, Inc.
P80-142-1745-S
In Commercial Distribution

  • 00889795098450 ()
P80-142-1745-S

  • Internal orthopaedic fixation system, plate/screw, non-bioabsorbable, sterile
Dynamic Syndesmosis Screw Ø4.2 X 60mm, 14mm Notch, Sterile
Paragon 28, Inc.
P80-142-1460-S
In Commercial Distribution

  • 00889795098436 ()
P80-142-1460-S

  • Internal orthopaedic fixation system, plate/screw, non-bioabsorbable, sterile
Dynamic Syndesmosis Screw Ø4.2 X 50mm, 14mm Notch, Sterile
Paragon 28, Inc.
P80-142-1450-S
In Commercial Distribution

  • 00889795098412 ()
P80-142-1450-S

  • Internal orthopaedic fixation system, plate/screw, non-bioabsorbable, sterile
Dynamic Syndesmosis Screw Ø4.2 X 40mm, 14mm Notch, Sterile
Paragon 28, Inc.
P80-142-1440-S
In Commercial Distribution

  • 00889795098399 ()
P80-142-1440-S

  • Internal orthopaedic fixation system, plate/screw, non-bioabsorbable, sterile
Phantom Hindfoot TTC/TC Nail, Tray 2, Case 2 of 3
Paragon 28, Inc.
P31-902-TRY2
In Commercial Distribution

  • 00889795098375 ()
P31-902-TRY2

  • Device sterilization/disinfection container, reusable
Phantom Hindfoot TTC/TC Nail, Case Base, Case 2 of 3
Paragon 28, Inc.
P31-902-BASE
In Commercial Distribution

  • 00889795098351 ()
P31-902-BASE

  • Device sterilization/disinfection container, reusable
Phantom Hindfoot TTC/TC Nail, Caddy 1 Base, Case 3 of 3
Paragon 28, Inc.
P31-903-C1BS
In Commercial Distribution

  • 00889795098320 ()
P31-903-C1BS

  • Device sterilization/disinfection container, reusable
Phantom Hindfoot TTC/TC Nail, Tray 2, Case 3 of 3
Paragon 28, Inc.
P31-903-TRY2
In Commercial Distribution

  • 00889795098306 ()
P31-903-TRY2

  • Device sterilization/disinfection container, reusable
Phantom Hindfoot TTC/TC Nail, Tray 1, Case 3 of 3
Paragon 28, Inc.
P31-903-TRY1
In Commercial Distribution

  • 00889795098290 ()
P31-903-TRY1

  • Device sterilization/disinfection container, reusable
Phantom Hindfoot TTC/TC Nail, Case Base, Case 3 of 3
Paragon 28, Inc.
P31-903-BASE
In Commercial Distribution

  • 00889795098283 ()
P31-903-BASE

  • Device sterilization/disinfection container, reusable
Phantom Hindfoot Nail, Compression End Cap, Long
Paragon 28, Inc.
P31-111-0000-07
In Commercial Distribution

  • 00889795098276 ()
P31-111-0000-07

  • Bone nail end-cap
Phantom Hindfoot Nail, Compression End Cap, Short
Paragon 28, Inc.
P31-111-0000-03
In Commercial Distribution

  • 00889795098269 ()
P31-111-0000-03

  • Bone nail end-cap
Phantom Hindfoot Nail, Shouldered End Cap, Long
Paragon 28, Inc.
P31-102-0005
In Commercial Distribution

  • 00889795098252 ()
P31-102-0005

  • Bone nail end-cap
Phantom Hindfoot Nail, Shouldered End Cap, Short
Paragon 28, Inc.
P31-102-0001
In Commercial Distribution

  • 00889795098245 ()
P31-102-0001

  • Bone nail end-cap
Phantom Hindfoot Nail, Internal Compression Screw
Paragon 28, Inc.
P31-101-0000-03
In Commercial Distribution

  • 00889795098238 ()
P31-101-0000-03

  • Bone-nailing compression screw
Phantom Nail, Crossing Screw, Ø5.0mm x 70mm length, Headed
Paragon 28, Inc.
P32-450-070F
In Commercial Distribution

  • 00889795098221 ()
P32-450-070F

  • Orthopaedic bone screw, non-bioabsorbable, non-sterile
Phantom Nail, Crossing Screw, Ø5.0mm x 68mm length, Headed
Paragon 28, Inc.
P32-450-068F
In Commercial Distribution

  • 00889795098214 ()
P32-450-068F

  • Orthopaedic bone screw, non-bioabsorbable, non-sterile
Phantom Nail, Crossing Screw, Ø5.0mm x 66mm length, Headed
Paragon 28, Inc.
P32-450-066F
In Commercial Distribution

  • 00889795098207 ()
P32-450-066F

  • Orthopaedic bone screw, non-bioabsorbable, non-sterile
Phantom Nail, Crossing Screw, Ø5.0mm x 64mm length, Headed
Paragon 28, Inc.
P32-450-064F
In Commercial Distribution

  • 00889795098191 ()
P32-450-064F

  • Orthopaedic bone screw, non-bioabsorbable, non-sterile
Phantom Nail, Crossing Screw, Ø5.0mm x 62mm length, Headed
Paragon 28, Inc.
P32-450-062F
In Commercial Distribution

  • 00889795098184 ()
P32-450-062F

  • Orthopaedic bone screw, non-bioabsorbable, non-sterile
Phantom Nail, Calcaneus Screw, Ø7.2mm x 55mm length, Headless
Paragon 28, Inc.
P31-772-055F
In Commercial Distribution

  • 00889795098177 ()
P31-772-055F

  • Orthopaedic bone screw, non-bioabsorbable, non-sterile
Phantom Nail, Calcaneus Screw, Ø7.2mm x 50mm length, Headless
Paragon 28, Inc.
P31-772-050F
In Commercial Distribution

  • 00889795098160 ()
P31-772-050F

  • Orthopaedic bone screw, non-bioabsorbable, non-sterile
Phantom Nail, Calcaneus Screw, Ø7.2mm x 45mm length, Headless
Paragon 28, Inc.
P31-772-045F
In Commercial Distribution

  • 00889795098153 ()
P31-772-045F

  • Orthopaedic bone screw, non-bioabsorbable, non-sterile
Phantom Screw Driver Attachment, Cannulated, 3/16" Sq. Connection, TX-30 x 85mm
Paragon 28, Inc.
P31-190-TX30-09
In Commercial Distribution

  • 00889795098146 ()
P31-190-TX30-09

  • Bone nail driver
Screw Driver Attachment, Solid, 3/16" Sq. Connection, TX-20 x 160mm
Paragon 28, Inc.
P99-191-TX20-16
In Commercial Distribution

  • 00889795098139 ()
P99-191-TX20-16

  • Bone nail driver
Phantom Hindfoot Depth Gauge, Cannulated
Paragon 28, Inc.
P31-957-0002
In Commercial Distribution

  • 00889795098122 ()
P31-957-0002

  • Surgical depth gauge, reusable
Phantom Hindfoot Depth Gauge, Solid
Paragon 28, Inc.
P31-957-0001
In Commercial Distribution

  • 00889795098115 ()
P31-957-0001

  • Surgical depth gauge, reusable
Drill, 3.8 X 250mm Drill, Solid, Trocar Tip, 3/16" Sq. Connection
Paragon 28, Inc.
P99-100-3825
In Commercial Distribution

  • 00889795098108 ()
P99-100-3825

  • Fluted surgical drill bit, single-use
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
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, Arc, Right, Size 6, Standard, 3DP
Paragon 28, Inc.
P10-100-BR6S-S
In Commercial Distribution

  • 00889795097514 ()
P10-100-BR6S-S

  • Fixed-bearing total ankle prosthesis
AVITRAC™ Core, MTP Reamer, Ø13 mm
Paragon 28, Inc.
P01-901-1301
In Commercial Distribution

  • 00889795097491 ()
P01-901-1301

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

  • 00889795097477 ()
P01-901-0901

  • Bone-resection orthopaedic reamer, reusable
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