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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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Close Encounter Nut
Paragon 28, Inc.
P45-941-0010
In Commercial Distribution

  • 00889795129147 ()
P45-941-0010

  • External orthopaedic fixation system, single-use
Nylon Lock Nut
Paragon 28, Inc.
P45-940-2001
In Commercial Distribution

  • 00889795129130 ()
P45-940-2001

  • External orthopaedic fixation system, single-use
Long Range Tensioner Tip
Paragon 28, Inc.
P45-540-0003
In Commercial Distribution

  • 00889795129123 ()
P45-540-0003

  • Orthopaedic prosthesis implantation positioning instrument, reusable
Universal Joint
Paragon 28, Inc.
P45-912-3000
In Commercial Distribution

  • 00889795129116 ()
P45-912-3000

  • External orthopaedic fixation system, single-use
BALL JOINT STRUT, MEDIUM
Paragon 28, Inc.
P45-223-0198
In Commercial Distribution

  • 00889795129093 ()
P45-223-0198

  • External orthopaedic fixation system, single-use
BALL JOINT STRUT, SMALL
Paragon 28, Inc.
P45-223-0118
In Commercial Distribution

  • 00889795129086 ()
P45-223-0118

  • External orthopaedic fixation system, single-use
BALL JOINT STRUT, X-SMALL
Paragon 28, Inc.
P45-223-0078
In Commercial Distribution

  • 00889795129079 ()
P45-223-0078

  • External orthopaedic fixation system, single-use
BALL JOINT STRUT, XX-SMALL
Paragon 28, Inc.
P45-223-0059
In Commercial Distribution

  • 00889795129062 ()
P45-223-0059

  • External orthopaedic fixation system, single-use
Saw Blade 39 x 10 x 0.4/0.6mm, Stryker (Sterile)
Paragon 28, Inc.
P99-151-P302-S
In Commercial Distribution

  • 00889795129055 ()
P99-151-P302-S

  • Surgical saw blade, sagittal, single-use
Saw Blade 39 x 10 x 0.4/0.6mm, MicroAire (Sterile)
Paragon 28, Inc.
P99-151-P301-S
In Commercial Distribution

  • 00889795129048 ()
P99-151-P301-S

  • Surgical saw blade, sagittal, single-use
Patient Specific Talus Trial, Large, Nylon
Paragon 28, Inc.
AOPSTT-XXXXL
In Commercial Distribution

  • 00889795128782 ()
AOPSTT-XXXXL

  • Coated ankle talus prosthesis
Patient Specific Talus Trial, Nominal, Nylon
Paragon 28, Inc.
AOPSTT-XXXXN
In Commercial Distribution

  • 00889795128775 ()
AOPSTT-XXXXN

  • Coated ankle talus prosthesis
Patient Specific Talus Trial, Small, Nylon
Paragon 28, Inc.
AOPSTT-XXXXS
In Commercial Distribution

  • 00889795128768 ()
AOPSTT-XXXXS

  • Coated ankle talus prosthesis
Tendon Harvester & Dilator Sterile Kit
Paragon 28, Inc.
P68-101-0000-SK
In Commercial Distribution

  • 00889795128751 ()
P68-101-0000-SK

  • Orthopaedic surgical procedure kit, non-medicated, reusable
K-Wire, Single Ended Trocar Tip, 1.30mm x 8cm
Paragon 28, Inc.
P35-941-1308
In Commercial Distribution

  • 00889795128744 ()
P35-941-1308

  • Orthopaedic bone wire
R3ACT Synds Imp 4.2x62mm, 17mm Ntch, St
Paragon 28, Inc.
P80-142-1762-S
In Commercial Distribution

  • 00889795128713 ()
P80-142-1762-S

  • Internal orthopaedic fixation system, plate/screw, non-bioabsorbable, sterile
R3ACT Synds Imp 4.2x57mm, 17mm Ntch, St
Paragon 28, Inc.
P80-142-1757-S
In Commercial Distribution

  • 00889795128706 ()
P80-142-1757-S

  • Internal orthopaedic fixation system, plate/screw, non-bioabsorbable, sterile
R3ACT Synds Imp 4.2x52mm, 17mm Ntch, St
Paragon 28, Inc.
P80-142-1752-S
In Commercial Distribution

  • 00889795128690 ()
P80-142-1752-S

  • Internal orthopaedic fixation system, plate/screw, non-bioabsorbable, sterile
R3ACT Synds Imp 4.2x47mm, 17mm Ntch, St
Paragon 28, Inc.
P80-142-1747-S
In Commercial Distribution

  • 00889795128683 ()
P80-142-1747-S

  • Internal orthopaedic fixation system, plate/screw, non-bioabsorbable, sterile
R3ACT Synds Imp 4.2x62mm, 14mm Ntch, St
Paragon 28, Inc.
P80-142-1462-S
In Commercial Distribution

  • 00889795128676 ()
P80-142-1462-S

  • Internal orthopaedic fixation system, plate/screw, non-bioabsorbable, sterile
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