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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Short Foot Rocker
Paragon 28, Inc.
P45-170-3000
In Commercial Distribution

  • 00889795129161 ()
P45-170-3000

  • External orthopaedic fixation system, single-use
Russian Wire Bolt
Paragon 28, Inc.
P45-913-2011
In Commercial Distribution

  • 00889795129154 ()
P45-913-2011

  • External orthopaedic fixation system, single-use
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
R3ACT Synds Imp 4.2x57mm, 14mm Ntch, St
Paragon 28, Inc.
P80-142-1457-S
In Commercial Distribution

  • 00889795128669 ()
P80-142-1457-S

  • Internal orthopaedic fixation system, plate/screw, non-bioabsorbable, sterile
R3ACT Synds Imp 4.2x52mm, 14mm Ntch, St
Paragon 28, Inc.
P80-142-1452-S
In Commercial Distribution

  • 00889795128652 ()
P80-142-1452-S

  • Internal orthopaedic fixation system, plate/screw, non-bioabsorbable, sterile
R3ACT Synds Imp 4.2x47mm, 14mm Ntch, St
Paragon 28, Inc.
P80-142-1447-S
In Commercial Distribution

  • 00889795128645 ()
P80-142-1447-S

  • Internal orthopaedic fixation system, plate/screw, non-bioabsorbable, sterile
R3ACT Synds Imp 4.2x42mm, 14mm Ntch, St
Paragon 28, Inc.
P80-142-1442-S
In Commercial Distribution

  • 00889795128638 ()
P80-142-1442-S

  • Internal orthopaedic fixation system, plate/screw, non-bioabsorbable, sterile
APEX 3D Total Ankle Replacement System, Large Instrumentation, Tray
Paragon 28, Inc.
P10-800-0006
In Commercial Distribution

  • 00889795128621 ()
P10-800-0006

  • Device sterilization/disinfection container, reusable
APEX 3D Total Ankle Replacement System, Impaction, Tray
Paragon 28, Inc.
P10-800-0005
In Commercial Distribution

  • 00889795128614 ()
P10-800-0005

  • Device sterilization/disinfection container, reusable
Oscillating Saw Blade, Large Stryker Power, 70 x 11.5 x 0.8
Paragon 28, Inc.
P99-151-P51L
In Commercial Distribution

  • 00889795128607 ()
P99-151-P51L

  • Surgical saw blade, oscillating, single-use
Oscillating Saw Blade, Small Stryker Power, 30 x 13 x 0.6
Paragon 28, Inc.
P99-151-P51S
In Commercial Distribution

  • 00889795128591 ()
P99-151-P51S

  • Surgical saw blade, oscillating, single-use
Total Ankle, Instrument, Poly Insertion Tool, Gen II, SS
Paragon 28, Inc.
P10-851-PT02
In Commercial Distribution

  • 00889795128577 ()
P10-851-PT02

  • Orthopaedic inorganic implant inserter/extractor, reusable
HammerTube™ System Implant Kit, Ø3.50 x 16mm, 10°, Sterile
Paragon 28, Inc.
P40-002-0350-SK
In Commercial Distribution

  • 00889795128485 ()
P40-002-0350-SK

  • Phalangeal joint arthrodesis implant
HammerTube System Peek Implant, Ø3.50mm x 16mm, 10°, Sterile
Paragon 28, Inc.
P40-002-0350-S
In Commercial Distribution

  • 00889795128478 ()
P40-002-0350-S

  • Phalangeal joint arthrodesis implant
HammerTube™ System Implant Kit, Ø2.75 x 14mm, 10°, Sterile
Paragon 28, Inc.
P40-002-0275-SK
In Commercial Distribution

  • 00889795128461 ()
P40-002-0275-SK

  • Phalangeal joint arthrodesis implant
Monster BITE, Driver, AO
Paragon 28, Inc.
P24-905-0001
In Commercial Distribution

  • 00889795016447 ()
P24-905-0001

  • Surgical screwdriver, reusable
Monster BITE Caddy, Lid
Paragon 28, Inc.
P24-900-BITE-3
In Commercial Distribution

  • 00889795016430 ()
P24-900-BITE-3

  • Device sterilization/disinfection container, reusable
Monster BITE Caddy, Insert
Paragon 28, Inc.
P24-900-BITE-2
In Commercial Distribution

  • 00889795016423 ()
P24-900-BITE-2

  • Device sterilization/disinfection container, reusable
7.0 mm Monster Screw Tap
Paragon 28, Inc.
P20-920-7000
In Commercial Distribution

  • 00889795016409 ()
P20-920-7000

  • Bone tap, reusable
5.5 mm Monster Screw Tap
Paragon 28, Inc.
P20-920-5500
In Commercial Distribution

  • 00889795016393 ()
P20-920-5500

  • Bone tap, reusable
3.5mm Mini Monster Tap
Paragon 28, Inc.
P20-920-3500
In Commercial Distribution

  • 00889795016362 ()
P20-920-3500

  • Bone tap, reusable
3.0mm Mini Monster Tap
Paragon 28, Inc.
P20-920-3000
In Commercial Distribution

  • 00889795016355 ()
P20-920-3000

  • Bone tap, reusable
Case Tray Mini Monster Full DIN
Paragon 28, Inc.
P20-900-0032
In Commercial Distribution

  • 00889795016331 ()
P20-900-0032

  • Device sterilization/disinfection container, reusable
Case Base, Mini Monster 5 Up
Paragon 28, Inc.
P20-900-0031
In Commercial Distribution

  • 00889795016324 ()
P20-900-0031

  • Device sterilization/disinfection container, reusable
Case Lid, Mini Monster
Paragon 28, Inc.
P20-900-0019
In Commercial Distribution

  • 00889795016294 ()
P20-900-0019

  • Device sterilization/disinfection container, reusable
Case Base, Mini Monster
Paragon 28, Inc.
P20-900-0018
In Commercial Distribution

  • 00889795016287 ()
P20-900-0018

  • Device sterilization/disinfection container, reusable
Caddy, Mini Monster, 2.5mm Lag Screw
Paragon 28, Inc.
P20-900-0016
In Commercial Distribution

  • 00889795016263 ()
P20-900-0016

  • Device sterilization/disinfection container, reusable
Mini-Monster 3.5mm Lag Screw Caddy
Paragon 28, Inc.
P20-900-0013
In Commercial Distribution

  • 00889795016232 ()
P20-900-0013

  • Device sterilization/disinfection container, reusable
Caddy Assy 3 (5.5mm)
Paragon 28, Inc.
P20-900-0006
In Commercial Distribution

  • 00889795016195 ()
P20-900-0006

  • Device sterilization/disinfection container, reusable
Caddy Assy 1 (7.0mm)
Paragon 28, Inc.
P20-900-0004
In Commercial Distribution

  • 00889795016171 ()
P20-900-0004

  • Device sterilization/disinfection container, reusable
Instrument Tray
Paragon 28, Inc.
P20-900-0003
In Commercial Distribution

  • 00889795016164 ()
P20-900-0003

  • Device sterilization/disinfection container, reusable
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