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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 Stablization System Implant, Ø4.2 X 50mm, 15.5mm Notch, Ti-6Al-4V ELI, Sterile
Paragon 28, Inc.
P80-142-1550-S
In Commercial Distribution

  • 00889795114433 ()
P80-142-1550-S

  • Internal orthopaedic fixation system, plate/screw, non-bioabsorbable, sterile
R3ACT Stablization System Implant, Ø4.2 X 70mm, 14mm Notch, Ti-6Al-4V ELI, Sterile
Paragon 28, Inc.
P80-142-1470-S
In Commercial Distribution

  • 00889795114402 ()
P80-142-1470-S

  • Internal orthopaedic fixation system, plate/screw, non-bioabsorbable, sterile
R3ACT Stablization System Implant, Ø4.2 X 65mm, 14mm Notch, Ti-6Al-4V ELI, Sterile
Paragon 28, Inc.
P80-142-1465-S
In Commercial Distribution

  • 00889795114396 ()
P80-142-1465-S

  • Internal orthopaedic fixation system, plate/screw, non-bioabsorbable, sterile
Cannulated Drill, ø4.5mm x 10cm, Sterile
Paragon 28, Inc.
P44-941-4310-S
In Commercial Distribution

  • 00889795114372 ()
P44-941-4310-S

  • Cannulated surgical drill bit, single-use
Cannulated Drill, ø3.5mm x 10cm, Sterile
Paragon 28, Inc.
P44-941-3510-S
In Commercial Distribution

  • 00889795114365 ()
P44-941-3510-S

  • Cannulated surgical drill bit, single-use
Cannulated Tap, Ø5.5mm x 10cm, Sterile
Paragon 28, Inc.
P44-960-0055-S
In Commercial Distribution

  • 00889795114358 ()
P44-960-0055-S

  • Bone tap, single-use
Cannulated Tap, Ø4.5mm x 10cm, Sterile
Paragon 28, Inc.
P44-960-0045-S
In Commercial Distribution

  • 00889795114341 ()
P44-960-0045-S

  • Bone tap, single-use
BridgeLine Suture Tape, 4mm, UHMWPE/PGLA, Sterile
Paragon 28, Inc.
P44-310-0004-S
In Commercial Distribution

  • 00889795114334 ()
P44-310-0004-S

  • Suturing unit, single-use
BridgeLine Suture Tape, 4mm, UHMWPE, Sterile
Paragon 28, Inc.
P44-300-0004-S
In Commercial Distribution

  • 00889795114327 ()
P44-300-0004-S

  • Suturing unit, single-use
Grappler Knotless Anchor, PEEK, ø5.5 x 15mm, Sterile Kit
Paragon 28, Inc.
P44-130-5515-SK
In Commercial Distribution

  • 00889795114310 ()
P44-130-5515-SK

  • General internal orthopaedic fixation system implantation kit
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