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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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Knotless Anchor, 4.5mm PEEK + Bridgeline Tape, Sterile Procedure Kit
Paragon 28, Inc.
P44-300-4515-SK
In Commercial Distribution

  • 00889795124258 ()
P44-300-4515-SK

  • General internal orthopaedic fixation system implantation kit
Universal T Chuck
Paragon 28, Inc.
P45-550-0001
In Commercial Distribution

  • 00889795124241 ()
P45-550-0001

  • Drilling power tool attachment, basic
JAWs Great White Nitinol Staple System, 25 x 20 x 20mm, Straight Staple Kit
Paragon 28, Inc.
P72-025-2020-S
In Commercial Distribution

  • 00889795124234 ()
P72-025-2020-S

  • Orthopaedic bone staple, non-adjustable
JAWs Great White Nitinol Staple System, 20 x 20 x 20mm, Straight Staple Kit
Paragon 28, Inc.
P72-020-2020-S
In Commercial Distribution

  • 00889795124227 ()
P72-020-2020-S

  • Orthopaedic bone staple, non-adjustable
JAWs Great White Nitinol Staple System, 18 x 18 x 18mm, Straight Staple Kit
Paragon 28, Inc.
P72-018-1818-S
In Commercial Distribution

  • 00889795124210 ()
P72-018-1818-S

  • Orthopaedic bone staple, non-adjustable
JAWs Great White Nitinol Staple System, 15 x 15 x 15mm, Straight Staple Kit
Paragon 28, Inc.
P72-015-1515-S
In Commercial Distribution

  • 00889795124203 ()
P72-015-1515-S

  • Orthopaedic bone staple, non-adjustable
JAWs Great White Nitinol Staple System, 12 x 12 x 12mm, Straight Staple Kit
Paragon 28, Inc.
P72-012-1212-S
In Commercial Distribution

  • 00889795124197 ()
P72-012-1212-S

  • Orthopaedic bone staple, non-adjustable
Met Shortening Depth Gage
Paragon 28, Inc.
P35-980-1000
In Commercial Distribution

  • 00889795124166 ()
P35-980-1000

  • Surgical depth gauge, reusable
Proximal Medial Tibia Plate, Large
Paragon 28, Inc.
P53-112-2002
In Commercial Distribution

  • 00889795124098 ()
P53-112-2002

  • Internal orthopaedic fixation system, plate/screw, non-bioabsorbable, non-sterile
Proximal Medial Tibia Plate, Standard
Paragon 28, Inc.
P53-112-2001
In Commercial Distribution

  • 00889795124081 ()
P53-112-2001

  • Internal orthopaedic fixation system, plate/screw, non-bioabsorbable, non-sterile
Distal Medial Tibia Plate, Large
Paragon 28, Inc.
P53-112-1002
In Commercial Distribution

  • 00889795124074 ()
P53-112-1002

  • Internal orthopaedic fixation system, plate/screw, non-bioabsorbable, non-sterile
Distal Medial Tibia Plate, Standard
Paragon 28, Inc.
P53-112-1001
In Commercial Distribution

  • 00889795124067 ()
P53-112-1001

  • Internal orthopaedic fixation system, plate/screw, non-bioabsorbable, non-sterile
Anterior Tibia Plate, Large
Paragon 28, Inc.
P53-112-0002
In Commercial Distribution

  • 00889795124050 ()
P53-112-0002

  • Internal orthopaedic fixation system, plate/screw, non-bioabsorbable, non-sterile
Anterior Tibia Plate, Standard
Paragon 28, Inc.
P53-112-0001
In Commercial Distribution

  • 00889795124043 ()
P53-112-0001

  • Internal orthopaedic fixation system, plate/screw, non-bioabsorbable, non-sterile
Gorilla, Supramalleolar Osteotomy System, Plating Caddy
Paragon 28, Inc.
P50-900-SMC1
In Commercial Distribution

  • 00889795124036 ()
P50-900-SMC1

  • Device sterilization/disinfection container, reusable
Strut Locking Clip (Bag of 10)
Paragon 28, Inc.
P45-225-0000
In Commercial Distribution

  • 00889795123961 ()
P45-225-0000

  • Orthopaedic fixation implant alignment tool
Suture Passer in pouch assembly
Paragon 28, Inc.
P44-970-0001-S
In Commercial Distribution

  • 00889795123954 ()
P44-970-0001-S

  • Suturing unit, single-use
Grappler Suture Anchor, Suture Passer, Sterile Kit pack of 10
Paragon 28, Inc.
P44-970-0001-SK
In Commercial Distribution

  • 00889795123954 ()
  • 00889795123947 ()
P44-970-0001-SK

  • General internal orthopaedic fixation system implantation kit
Grappler Knotless, 2 Anchor, ø4.5 x 15mm, Sterile Kit with instruments
Paragon 28, Inc.
P44-132-4515-SK
In Commercial Distribution

  • 00889795123930 ()
P44-132-4515-SK

  • General internal orthopaedic fixation system implantation kit
Grappler Knotless Anchor, PEEK, ø5.5 x 15mm, Anchor/Driver only, Sterile Kit
Paragon 28, Inc.
P44-131-5515-SK
In Commercial Distribution

  • 00889795123923 ()
P44-131-5515-SK

  • General internal orthopaedic fixation system implantation kit
Grappler Knotless Anchor, PEEK, ø4.5 x 15mm, Anchor/Driver only, Sterile Kit
Paragon 28, Inc.
P44-131-4515-SK
In Commercial Distribution

  • 00889795123916 ()
P44-131-4515-SK

  • General internal orthopaedic fixation system implantation kit
Met Shortening Implant Caddy, Lid
Paragon 28, Inc.
P35-900-0004
In Commercial Distribution

  • 00889795123879 ()
P35-900-0004

  • Device sterilization/disinfection container, reusable
Met Shortening Implant Caddy, Base
Paragon 28, Inc.
P35-900-0003
In Commercial Distribution

  • 00889795123862 ()
P35-900-0003

  • Device sterilization/disinfection container, reusable
K-Wire, Single Ended Trocar Tip, SMOOTH, 1.10mm x 5cm
Paragon 28, Inc.
P99-192-1105
In Commercial Distribution

  • 00889795123855 ()
P99-192-1105

  • Orthopaedic bone wire
Saw Blade 5.5 x 25 x 0.4/0.6mm, Stryker (Sterile)
Paragon 28, Inc.
P99-151-P35S-S
In Commercial Distribution

  • 00889795123848 ()
P99-151-P35S-S

  • Surgical saw blade, oscillating, single-use
Saw Blade 5.5 x 25 x 0.4/0.6mm, MicroAir (Sterile)
Paragon 28, Inc.
P99-151-P35M-S
In Commercial Distribution

  • 00889795123831 ()
P99-151-P35M-S

  • Surgical saw blade, oscillating, single-use
Mini Skin Hook
Paragon 28, Inc.
P99-150-0144
In Commercial Distribution

  • 00889795123824 ()
P99-150-0144

  • Bone hook
Met Shortening Reamer, 2.7
Paragon 28, Inc.
P35-970-0027
In Commercial Distribution

  • 00889795123817 ()
P35-970-0027

  • Bone-resection orthopaedic reamer, reusable
Met Shortening Slot Wrench
Paragon 28, Inc.
P35-960-1000
In Commercial Distribution

  • 00889795123800 ()
P35-960-1000

  • Surgical torque wrench, reusable
Met Shortening Shmogler Elevator
Paragon 28, Inc.
P35-950-1000
In Commercial Distribution

  • 00889795123794 ()
P35-950-1000

  • Periosteal elevator, reusable
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