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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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FJ-2000, MIS Irrigation Kit (Sterile)
Paragon 28, Inc.
P65-001-0006-SK
In Commercial Distribution

  • 00889795131140 ()
P65-001-0006-SK

  • Surgical power tool system control unit, line-powered
Wedge Bone Burr, 4.3 x 13 x 72, AO (Sterile)
Paragon 28, Inc.
P65-108-4313-S
In Commercial Distribution

  • 00889795131133 ()
P65-108-4313-S

  • Orthopaedic bur, single-use
Wedge Bone Burr, 2.9 x 13 x 72, AO (Sterile)
Paragon 28, Inc.
P65-108-2913-S
In Commercial Distribution

  • 00889795131126 ()
P65-108-2913-S

  • Orthopaedic bur, single-use
Shannon-style Recta Bone Burr, 3.0 x 30 x 82, AO (Sterile)
Paragon 28, Inc.
P65-105-3030-S
In Commercial Distribution

  • 00889795131119 ()
P65-105-3030-S

  • Orthopaedic bur, single-use
Shannon-style Recta Bone Burr, 2.2 x 20 x 82, AO (Sterile)
Paragon 28, Inc.
P65-105-2221-S
In Commercial Distribution

  • 00889795131102 ()
P65-105-2221-S

  • Orthopaedic bur, single-use
Shannon-style Recta Bone Burr, 2.2 x 20 x 72, AO (Sterile)
Paragon 28, Inc.
P65-105-2220-S
In Commercial Distribution

  • 00889795131096 ()
P65-105-2220-S

  • Orthopaedic bur, single-use
Shannon-style Recta Bone Burr, 2.0 x 20 x 72, AO (Sterile)
Paragon 28, Inc.
P65-105-2020-S
In Commercial Distribution

  • 00889795131089 ()
P65-105-2020-S

  • Orthopaedic bur, single-use
Shannon-style Recta Bone Burr, 2.0 x 13 x 72, AO (Sterile)
Paragon 28, Inc.
P65-105-2013-S
In Commercial Distribution

  • 00889795131072 ()
P65-105-2013-S

  • Orthopaedic bur, single-use
Shannon-style Corta Bone Burr, 2.0 x 8 x 72, AO (Sterile)
Paragon 28, Inc.
P65-105-2008-S
In Commercial Distribution

  • 00889795131065 ()
P65-105-2008-S

  • Orthopaedic bur, single-use
FJ-2000, Minimally Invasive Procedure Kit for Hardware (Sterile)
Paragon 28, Inc.
P65-001-0002-SK
In Commercial Distribution

  • 00889795131058 ()
P65-001-0002-SK

  • Surgical power tool system control unit, line-powered
FJ-2000, MIS Hand Piece and AO Connection Kit (Sterile)
Paragon 28, Inc.
P65-001-0001-SK
In Commercial Distribution

  • 00889795131041 ()
P65-001-0001-SK

  • Surgical power tool system control unit, line-powered
Ø2.7mm Cannulated Drill for Ø3.5 Screw, Long
Paragon 28, Inc.
P27-110-2720
In Commercial Distribution

  • 00889795131034 ()
P27-110-2720

  • Cannulated surgical drill bit, single-use
Ø3.0mm Cannulated Drill for Ø4.0 Screw, Long
Paragon 28, Inc.
P27-110-3020
In Commercial Distribution

  • 00889795131027 ()
P27-110-3020

  • Cannulated surgical drill bit, single-use
Monkey Rings, Case 2, Tray 3
Paragon 28, Inc.
P45-902-TRY3
In Commercial Distribution

  • 00889795131010 ()
P45-902-TRY3

  • Device sterilization/disinfection container, reusable
Slotted Mallet
Paragon 28, Inc.
P99-150-2006
In Commercial Distribution

  • 00889795130938 ()
P99-150-2006

  • Orthopaedic implantation hammering attachment
Vice Grips
Paragon 28, Inc.
P99-150-2008
In Commercial Distribution

  • 00889795130921 ()
P99-150-2008

  • Surgical vice grip
U Handle
Paragon 28, Inc.
P99-150-2007
In Commercial Distribution

  • 00889795130914 ()
P99-150-2007

  • Surgical instrument handle, torque-limiting
3/16th Adapter
Paragon 28, Inc.
P99-000-316B
In Commercial Distribution

  • 00889795130891 ()
P99-000-316B

  • Surgical screwdriver, reusable
Screw Remover, Small
Paragon 28, Inc.
P31-958-3013
In Commercial Distribution

  • 00889795130884 ()
P31-958-3013

  • Bone-resection orthopaedic reamer, single-use
Screw Remover, Med
Paragon 28, Inc.
P31-958-3012
In Commercial Distribution

  • 00889795130877 ()
P31-958-3012

  • Bone-resection orthopaedic reamer, single-use
Screw Remover, Large
Paragon 28, Inc.
P31-958-3011
In Commercial Distribution

  • 00889795130860 ()
P31-958-3011

  • Bone-resection orthopaedic reamer, single-use
Screw Reamer, Small
Paragon 28, Inc.
P31-958-3003
In Commercial Distribution

  • 00889795130853 ()
P31-958-3003

  • Bone-resection orthopaedic reamer, single-use
Screw Reamer, Med
Paragon 28, Inc.
P31-958-3002
In Commercial Distribution

  • 00889795130846 ()
P31-958-3002

  • Bone-resection orthopaedic reamer, single-use
Screw Reamer, Large
Paragon 28, Inc.
P31-958-3001
In Commercial Distribution

  • 00889795130839 ()
P31-958-3001

  • Bone-resection orthopaedic reamer, single-use
Nail Trephine
Paragon 28, Inc.
P31-958-3000
In Commercial Distribution

  • 00889795130822 ()
P31-958-3000

  • Bone trephine, reusable
Calc Screw Easy Out
Paragon 28, Inc.
P31-958-0030
In Commercial Distribution

  • 00889795130815 ()
P31-958-0030

  • Orthopaedic inorganic implant inserter/extractor, single-use
Crossing Screw Easy Out
Paragon 28, Inc.
P31-958-0020
In Commercial Distribution

  • 00889795130808 ()
P31-958-0020

  • Orthopaedic inorganic implant inserter/extractor, single-use
End Cap Easy Out
Paragon 28, Inc.
P31-958-0010
In Commercial Distribution

  • 00889795130792 ()
P31-958-0010

  • Orthopaedic inorganic implant inserter/extractor, single-use
17mm Hex Nut
Paragon 28, Inc.
P31-958-1003
In Commercial Distribution

  • 00889795130785 ()
P31-958-1003

  • Surgical torque wrench, reusable
17mm Wrench
Paragon 28, Inc.
P31-958-1001
In Commercial Distribution

  • 00889795130761 ()
P31-958-1001

  • Surgical torque wrench, reusable
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