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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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FJ2000 System - 00889795131102

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

FJ2000 System - 00889795131096

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

FJ2000 System - 00889795131089

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

FJ2000 System - 00889795131072

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

FJ2000 System - 00889795131065

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

FJ2000 System - 00889795131058

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

FJ2000 System - 00889795131041

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

Precision MIS Bunion System - 00889795131034

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

Precision MIS Bunion System - 00889795131027

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™ External Fixation System - 00889795131010

Monkey Rings, Case 2, Tray 3
Paragon 28, Inc.
P45-902-TRY3
In Commercial Distribution

  • 00889795131010 ()
P45-902-TRY3

  • Device sterilization/disinfection container, reusable
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