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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MTP Spin Guard™ Female Reamer, 17mm
Paragon 28, Inc.
P01-900-1702
In Commercial Distribution

  • 00889795034861 ()
P01-900-1702

  • Bone-resection orthopaedic reamer, reusable
Medial Column Straddle, Left, Extra Large
Paragon 28, Inc.
P53-109-L214
In Commercial Distribution

  • 00889795034816 ()
P53-109-L214

  • Orthopaedic fixation plate, non-bioabsorbable, non-sterile
Medial Column Straddle, Left, Large
Paragon 28, Inc.
P53-109-L213
In Commercial Distribution

  • 00889795034809 ()
P53-109-L213

  • Orthopaedic fixation plate, non-bioabsorbable, non-sterile
Medial Column Straddle, Left, Medium
Paragon 28, Inc.
P53-109-L212
In Commercial Distribution

  • 00889795034793 ()
P53-109-L212

  • Orthopaedic fixation plate, non-bioabsorbable, non-sterile
Medial Column Straddle, Left, Small
Paragon 28, Inc.
P53-109-L211
In Commercial Distribution

  • 00889795034786 ()
P53-109-L211

  • Orthopaedic fixation plate, non-bioabsorbable, non-sterile
Medial Column Straddle, Left, Extra Small
Paragon 28, Inc.
P53-109-L210
In Commercial Distribution

  • 00889795034779 ()
P53-109-L210

  • Orthopaedic fixation plate, non-bioabsorbable, non-sterile
Medial Column Straddle, Right, Extra Large
Paragon 28, Inc.
P53-109-R214
In Commercial Distribution

  • 00889795034762 ()
P53-109-R214

  • Orthopaedic fixation plate, non-bioabsorbable, non-sterile
Medial Column Straddle, Right, Large
Paragon 28, Inc.
P53-109-R213
In Commercial Distribution

  • 00889795034755 ()
P53-109-R213

  • Orthopaedic fixation plate, non-bioabsorbable, non-sterile
Medial Column Straddle, Right, Medium
Paragon 28, Inc.
P53-109-R212
In Commercial Distribution

  • 00889795034748 ()
P53-109-R212

  • Orthopaedic fixation plate, non-bioabsorbable, non-sterile
Medial Column Straddle, Right, Small
Paragon 28, Inc.
P53-109-R211
In Commercial Distribution

  • 00889795034731 ()
P53-109-R211

  • Orthopaedic fixation plate, non-bioabsorbable, non-sterile
Medial Column Straddle, Right, Extra Small
Paragon 28, Inc.
P53-109-R210
In Commercial Distribution

  • 00889795034724 ()
P53-109-R210

  • Orthopaedic fixation plate, non-bioabsorbable, non-sterile
Baby Gorilla, Plate, Hook, 6 Hole, Comp., Right, 1.2mm, TiA
Paragon 28, Inc.
P53-008-RC06
In Commercial Distribution

  • 00889795034717 ()
P53-008-RC06

  • Orthopaedic fixation plate, non-bioabsorbable, non-sterile
Baby Gorilla, Plate, Hook, 6 Hole, Comp., Left, 1.2mm, TiA
Paragon 28, Inc.
P53-008-LC06
In Commercial Distribution

  • 00889795034700 ()
P53-008-LC06

  • Orthopaedic fixation plate, non-bioabsorbable, non-sterile
Gorilla, Lapidus Plate, Standard, No Plantar Arm, Right
Paragon 28, Inc.
P53-106-R101
In Commercial Distribution

  • 00889795034694 ()
P53-106-R101

  • Orthopaedic fixation plate, non-bioabsorbable, non-sterile
Gorilla, Lapidus Plate, Standard, No Plantar Arm, Left
Paragon 28, Inc.
P53-106-L101
In Commercial Distribution

  • 00889795034687 ()
P53-106-L101

  • Orthopaedic fixation plate, non-bioabsorbable, non-sterile
Gorilla, Ankle Fx, Trimalleolar Fracture Plate, 04-Hole
Paragon 28, Inc.
P53-211-0004
In Commercial Distribution

  • 00889795034670 ()
P53-211-0004

  • Orthopaedic fixation plate, non-bioabsorbable, non-sterile
Gorilla, Ankle Fx, Trimalleolar Fracture Plate, 03-Hole
Paragon 28, Inc.
P53-211-0003
In Commercial Distribution

  • 00889795034663 ()
P53-211-0003

  • Orthopaedic fixation plate, non-bioabsorbable, non-sterile
Gorilla, Ankle Fx, Posteromedial Distal Tibia Plate, 08-Hole, Right
Paragon 28, Inc.
P53-209-R008
In Commercial Distribution

  • 00889795034656 ()
P53-209-R008

  • Orthopaedic fixation plate, non-bioabsorbable, non-sterile
Gorilla, Ankle Fx, Posteromedial Distal Tibia Plate, 06-Hole, Right
Paragon 28, Inc.
P53-209-R006
In Commercial Distribution

  • 00889795034649 ()
P53-209-R006

  • Orthopaedic fixation plate, non-bioabsorbable, non-sterile
Gorilla, Ankle Fx, Posteromedial Distal Tibia Plate, 08-Hole, Left
Paragon 28, Inc.
P53-209-L008
In Commercial Distribution

  • 00889795034632 ()
P53-209-L008

  • Orthopaedic fixation plate, non-bioabsorbable, non-sterile
Gorilla, Ankle Fx, Posteromedial Distal Tibia Plate, 06-Hole, Left
Paragon 28, Inc.
P53-209-L006
In Commercial Distribution

  • 00889795034625 ()
P53-209-L006

  • Orthopaedic fixation plate, non-bioabsorbable, non-sterile
Gorilla, Ankle Fx, Posterolateral Tibia Plate, 08-Hole, Right
Paragon 28, Inc.
P53-207-R008
In Commercial Distribution

  • 00889795034618 ()
P53-207-R008

  • Orthopaedic fixation plate, non-bioabsorbable, non-sterile
Gorilla, Ankle Fx, Posterolateral Tibia Plate, 07-Hole, Right
Paragon 28, Inc.
P53-207-R007
In Commercial Distribution

  • 00889795034601 ()
P53-207-R007

  • Orthopaedic fixation plate, non-bioabsorbable, non-sterile
Gorilla, Ankle Fx, Posterolateral Tibia Plate, 06-Hole, Right
Paragon 28, Inc.
P53-207-R006
In Commercial Distribution

  • 00889795034595 ()
P53-207-R006

  • Orthopaedic fixation plate, non-bioabsorbable, non-sterile
Gorilla, Ankle Fx, Posterolateral Tibia Plate, 05-Hole, Right
Paragon 28, Inc.
P53-207-R005
In Commercial Distribution

  • 00889795034588 ()
P53-207-R005

  • Orthopaedic fixation plate, non-bioabsorbable, non-sterile
Gorilla, Ankle Fx, Posterolateral Tibia Plate, 08-Hole, Left
Paragon 28, Inc.
P53-207-L008
In Commercial Distribution

  • 00889795034571 ()
P53-207-L008

  • Orthopaedic fixation plate, non-bioabsorbable, non-sterile
Gorilla, Ankle Fx, Posterolateral Tibia Plate, 07-Hole, Left
Paragon 28, Inc.
P53-207-L007
In Commercial Distribution

  • 00889795034564 ()
P53-207-L007

  • Orthopaedic fixation plate, non-bioabsorbable, non-sterile
Gorilla, Ankle Fx, Posterolateral Tibia Plate, 06-Hole, Left
Paragon 28, Inc.
P53-207-L006
In Commercial Distribution

  • 00889795034557 ()
P53-207-L006

  • Orthopaedic fixation plate, non-bioabsorbable, non-sterile
Gorilla, Ankle Fx, Posterolateral Tibia Plate, 05-Hole, Left
Paragon 28, Inc.
P53-207-L005
In Commercial Distribution

  • 00889795034540 ()
P53-207-L005

  • Orthopaedic fixation plate, non-bioabsorbable, non-sterile
Gorilla, Posterolateral, Fibular, 11-Hole, w/Comp, Beta
Paragon 28, Inc.
P53-208-1011
In Commercial Distribution

  • 00889795034533 ()
P53-208-1011

  • Orthopaedic fixation plate, non-bioabsorbable, non-sterile
Gorilla, Posterolateral, Fibular, 07-Hole, Beta
Paragon 28, Inc.
P53-208-1007
In Commercial Distribution

  • 00889795034519 ()
P53-208-1007

  • Orthopaedic fixation plate, non-bioabsorbable, non-sterile
Gorilla, Posterolateral, Fibular, 09-Hole, w/Comp, Alpha
Paragon 28, Inc.
P53-208-0009
In Commercial Distribution

  • 00889795034496 ()
P53-208-0009

  • Orthopaedic fixation plate, non-bioabsorbable, non-sterile
Gorilla, Ankle Fx, Medial Malleolus Plate, Hook, 02-Hole
Paragon 28, Inc.
P53-206-0002
In Commercial Distribution

  • 00889795034472 ()
P53-206-0002

  • Orthopaedic fixation plate, non-bioabsorbable, non-sterile
Gorilla, Lateral Maleolus, Hook, Anatomical, Right, 05-Hole
Paragon 28, Inc.
P53-205-R005
In Commercial Distribution

  • 00889795034458 ()
P53-205-R005

  • Orthopaedic fixation plate, non-bioabsorbable, non-sterile
Gorilla, Lateral Maleolus, Hook, Anatomical, Left, 05-Hole
Paragon 28, Inc.
P53-205-L005
In Commercial Distribution

  • 00889795034434 ()
P53-205-L005

  • Orthopaedic fixation plate, non-bioabsorbable, non-sterile
Gorilla, Fibular, Straight, Hook, 05-Hole
Paragon 28, Inc.
P53-204-0005
In Commercial Distribution

  • 00889795034410 ()
P53-204-0005

  • Orthopaedic fixation plate, non-bioabsorbable, non-sterile
Precision Jones Screw System Case Base
Paragon 28, Inc.
P25-900-CASE
In Commercial Distribution

  • 00889795023018 ()
P25-900-CASE

  • Device sterilization/disinfection container, reusable
P28, Driver, HX15, Cannulated, SS
Paragon 28, Inc.
P99-190-TJ15
In Commercial Distribution

  • 00889795022998 ()
P99-190-TJ15

  • Surgical screwdriver, reusable
ø1.6mm X 200mm NiTiNol K-Wire, SMOOTH
Paragon 28, Inc.
P99-172-1620
In Commercial Distribution

  • 00889795022981 ()
P99-172-1620

  • Orthopaedic bone wire
Monster, Screw, Ø4.5 x 65mm, Headed, Short Thd, Solid, Blunt Tip, TiA
Paragon 28, Inc.
P25-445-065S
In Commercial Distribution

  • 00889795022127 ()
P25-445-065S

  • Orthopaedic bone screw, non-bioabsorbable, non-sterile
Monster, Screw, Ø4.5 x 60mm, Headed, Short Thd, Solid, Blunt Tip, TiA
Paragon 28, Inc.
P25-445-060S
In Commercial Distribution

  • 00889795022110 ()
P25-445-060S

  • Orthopaedic bone screw, non-bioabsorbable, non-sterile
Monster, Screw, Ø4.5 x 58mm, Headed, Short Thd, Solid, Blunt Tip, TiA
Paragon 28, Inc.
P25-445-058S
In Commercial Distribution

  • 00889795022103 ()
P25-445-058S

  • Orthopaedic bone screw, non-bioabsorbable, non-sterile
Monster, Screw, Ø4.5 x 56mm, Headed, Short Thd, Solid, Blunt Tip, TiA
Paragon 28, Inc.
P25-445-056S
In Commercial Distribution

  • 00889795022097 ()
P25-445-056S

  • Orthopaedic bone screw, non-bioabsorbable, non-sterile
Monster, Screw, Ø4.5 x 54mm, Headed, Short Thd, Solid, Blunt Tip, TiA
Paragon 28, Inc.
P25-445-054S
In Commercial Distribution

  • 00889795022080 ()
P25-445-054S

  • Orthopaedic bone screw, non-bioabsorbable, non-sterile
Monster, Screw, Ø4.5 x 52mm, Headed, Short Thd, Solid, Blunt Tip, TiA
Paragon 28, Inc.
P25-445-052S
In Commercial Distribution

  • 00889795022073 ()
P25-445-052S

  • Orthopaedic bone screw, non-bioabsorbable, non-sterile
Monster, Screw, Ø4.5 x 46mm, Headed, Short Thd, Solid, Blunt Tip, TiA
Paragon 28, Inc.
P25-445-046S
In Commercial Distribution

  • 00889795022042 ()
P25-445-046S

  • Orthopaedic bone screw, non-bioabsorbable, non-sterile
Monster, Screw, Ø4.5 x 44mm, Headed, Short Thd, Solid, Blunt Tip, TiA
Paragon 28, Inc.
P25-445-044S
In Commercial Distribution

  • 00889795022035 ()
P25-445-044S

  • Orthopaedic bone screw, non-bioabsorbable, non-sterile
Monster, Screw, Ø4.5 x 42mm, Headed, Short Thd, Solid, Blunt Tip, TiA
Paragon 28, Inc.
P25-445-042S
In Commercial Distribution

  • 00889795022028 ()
P25-445-042S

  • Orthopaedic bone screw, non-bioabsorbable, non-sterile
Monster, Screw, Ø4.5 x 40mm, Headed, Short Thd, Solid, Blunt Tip, TiA
Paragon 28, Inc.
P25-445-040S
In Commercial Distribution

  • 00889795022011 ()
P25-445-040S

  • Orthopaedic bone screw, non-bioabsorbable, non-sterile
Monster, Screw, Ø4.5 x 38mm, Headed, Short Thd, Solid, Blunt Tip, TiA
Paragon 28, Inc.
P25-445-038S
In Commercial Distribution

  • 00889795022004 ()
P25-445-038S

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