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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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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
HammerTube System Peek Implant, Ø2.75mm x 14mm, 10°, Sterile
Paragon 28, Inc.
P40-002-0275-S
In Commercial Distribution

  • 00889795128454 ()
P40-002-0275-S

  • Phalangeal joint arthrodesis implant
HammerTube™ System Implant Kit, Ø3.50 x 16mm, 0°, Sterile
Paragon 28, Inc.
P40-001-0350-SK
In Commercial Distribution

  • 00889795128447 ()
P40-001-0350-SK

  • Phalangeal joint arthrodesis implant
HammerTube System Peek Implant, Ø3.50mm x 16mm, 0°, Sterile
Paragon 28, Inc.
P40-001-0350-S
In Commercial Distribution

  • 00889795128430 ()
P40-001-0350-S

  • Phalangeal joint arthrodesis implant
HammerTube™ System Implant Kit, Ø2.75 x 14mm, 0°, Sterile
Paragon 28, Inc.
P40-001-0275-SK
In Commercial Distribution

  • 00889795128423 ()
P40-001-0275-SK

  • Phalangeal joint arthrodesis implant
HammerTube System Peek Implant, Ø2.75mm x 14mm, 0°, Sterile
Paragon 28, Inc.
P40-001-0275-S
In Commercial Distribution

  • 00889795128416 ()
P40-001-0275-S

  • Phalangeal joint arthrodesis implant
MODULAR BALL JOINT
Paragon 28, Inc.
P45-233-1000
In Commercial Distribution

  • 00889795128409 ()
P45-233-1000

  • External orthopaedic fixation system, single-use
Grappler Interference Screw System, Screw, Ø8 mm x 25 mm, Sterile
Paragon 28, Inc.
P41-080-2500-S
In Commercial Distribution

  • 00889795128393 ()
P41-080-2500-S

  • Tendon/ligament bone anchor, non-bioabsorbable
Grappler Interference Screw System, Screw, Ø8 mm x 20 mm, Sterile
Paragon 28, Inc.
P41-080-2000-S
In Commercial Distribution

  • 00889795128386 ()
P41-080-2000-S

  • Tendon/ligament bone anchor, non-bioabsorbable
Grappler Interference Screw System, Screw, Ø7 mm x 25 mm, Sterile
Paragon 28, Inc.
P41-070-2500-S
In Commercial Distribution

  • 00889795128379 ()
P41-070-2500-S

  • Tendon/ligament bone anchor, non-bioabsorbable
Grappler Interference Screw System, Screw, Ø7 mm x 20 mm, Sterile
Paragon 28, Inc.
P41-070-2000-S
In Commercial Distribution

  • 00889795128362 ()
P41-070-2000-S

  • Tendon/ligament bone anchor, non-bioabsorbable
Grappler Interference Screw System, Screw, Ø6 mm x 25 mm, Sterile
Paragon 28, Inc.
P41-060-2500-S
In Commercial Distribution

  • 00889795128355 ()
P41-060-2500-S

  • Tendon/ligament bone anchor, non-bioabsorbable
Grappler Interference Screw System, Screw, Ø6 mm x 20 mm, Sterile
Paragon 28, Inc.
P41-060-2000-S
In Commercial Distribution

  • 00889795128348 ()
P41-060-2000-S

  • Tendon/ligament bone anchor, non-bioabsorbable
Grappler Interference Screw System, Screw, Ø6 mm x 15 mm, Sterile
Paragon 28, Inc.
P41-060-1500-S
In Commercial Distribution

  • 00889795128331 ()
P41-060-1500-S

  • Tendon/ligament bone anchor, non-bioabsorbable
Grappler Interference Screw System, Screw, Ø5.5 mm x 25 mm, Sterile
Paragon 28, Inc.
P41-055-2500-S
In Commercial Distribution

  • 00889795128324 ()
P41-055-2500-S

  • Tendon/ligament bone anchor, non-bioabsorbable
Grappler Interference Screw System, Screw, Ø5.5 mm x 20 mm, Sterile
Paragon 28, Inc.
P41-055-2000-S
In Commercial Distribution

  • 00889795128317 ()
P41-055-2000-S

  • Tendon/ligament bone anchor, non-bioabsorbable
Grappler Interference Screw System, Screw, Ø5.5 mm x 15 mm, Sterile
Paragon 28, Inc.
P41-055-1500-S
In Commercial Distribution

  • 00889795128300 ()
P41-055-1500-S

  • Tendon/ligament bone anchor, non-bioabsorbable
Grappler Interference Screw System, Screw, Ø5 mm x 25 mm, Sterile
Paragon 28, Inc.
P41-050-2500-S
In Commercial Distribution

  • 00889795128294 ()
P41-050-2500-S

  • Tendon/ligament bone anchor, non-bioabsorbable
Grappler Interference Screw System, Screw, Ø5 mm x 20 mm, Sterile
Paragon 28, Inc.
P41-050-2000-S
In Commercial Distribution

  • 00889795128287 ()
P41-050-2000-S

  • Tendon/ligament bone anchor, non-bioabsorbable
Grappler Interference Screw System, Screw, Ø5 mm x 15 mm, Sterile
Paragon 28, Inc.
P41-050-1500-S
In Commercial Distribution

  • 00889795128270 ()
P41-050-1500-S

  • Tendon/ligament bone anchor, non-bioabsorbable
Grappler Interference Screw System, Screw, Ø5 mm x 10 mm, Sterile
Paragon 28, Inc.
P41-050-1000-S
In Commercial Distribution

  • 00889795128263 ()
P41-050-1000-S

  • Tendon/ligament bone anchor, non-bioabsorbable
Grappler Interference Screw System, Screw, Ø4.5 mm x 20 mm, Sterile
Paragon 28, Inc.
P41-045-2000-S
In Commercial Distribution

  • 00889795128256 ()
P41-045-2000-S

  • Tendon/ligament bone anchor, non-bioabsorbable
Grappler Interference Screw System, Screw, Ø4.5 mm x 15 mm, Sterile
Paragon 28, Inc.
P41-045-1500-S
In Commercial Distribution

  • 00889795128249 ()
P41-045-1500-S

  • Tendon/ligament bone anchor, non-bioabsorbable
Grappler Interference Screw System, Screw, Ø4.5 mm x 10 mm, Sterile
Paragon 28, Inc.
P41-045-1000-S
In Commercial Distribution

  • 00889795128232 ()
P41-045-1000-S

  • Tendon/ligament bone anchor, non-bioabsorbable
Grappler Interference Screw System, Screw, Ø4 mm x 20 mm, Sterile
Paragon 28, Inc.
P41-040-2000-S
In Commercial Distribution

  • 00889795128225 ()
P41-040-2000-S

  • Tendon/ligament bone anchor, non-bioabsorbable
Grappler Interference Screw System, Screw, Ø4 mm x 15 mm, Sterile
Paragon 28, Inc.
P41-040-1500-S
In Commercial Distribution

  • 00889795128218 ()
P41-040-1500-S

  • Tendon/ligament bone anchor, non-bioabsorbable
Grappler Interference Screw System, Screw, Ø4 mm x 10 mm, Sterile
Paragon 28, Inc.
P41-040-1000-S
In Commercial Distribution

  • 00889795128201 ()
P41-040-1000-S

  • Tendon/ligament bone anchor, non-bioabsorbable
Monkey Rings, Case 3, Caddy 3, Fasteners
Paragon 28, Inc.
P45-903-CAD3
In Commercial Distribution

  • 00889795128157 ()
P45-903-CAD3

  • Device sterilization/disinfection container, reusable
Grappler R3FLEX Single Implant Kit
Paragon 28, Inc.
P82-001-1237-SK
In Commercial Distribution

  • 00889795128140 ()
P82-001-1237-SK

  • Orthopaedic surgical procedure kit, non-medicated, single-use
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