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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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Short Stem Tibia, FLAT, Short Stem (12X9MM Lattice), Right, Size 1, Standard, 3DP - Sterile
Paragon 28, Inc.
P11-181-BR1S-S
In Commercial Distribution

  • 00889795137807 ()
P11-181-BR1S-S

  • Fixed-bearing total ankle prosthesis
Short Stem Tibia, FLAT, Short Stem (12X12MM Lattice), Left, Size 6, Long, 3DP - Sterile
Paragon 28, Inc.
P11-181-BL6L-S
In Commercial Distribution

  • 00889795137784 ()
P11-181-BL6L-S

  • Fixed-bearing total ankle prosthesis
Short Stem Tibia, FLAT, Short Stem (12X12MM Lattice), Left, Size 5, Long, 3DP - Sterile
Paragon 28, Inc.
P11-181-BL5L-S
In Commercial Distribution

  • 00889795137753 ()
P11-181-BL5L-S

  • Fixed-bearing total ankle prosthesis
Short Stem Tibia, Tibia, FLAT, Short Stem (12X10.5MM Lattice), Left, Size 4, Long, 3DP - Sterile
Paragon 28, Inc.
P11-181-BL4L-S
In Commercial Distribution

  • 00889795137722 ()
P11-181-BL4L-S

  • Fixed-bearing total ankle prosthesis
Short Stem Tibia, Instrument, Drill Bit Cap D9, Short
Paragon 28, Inc.
P11-854-C09S
In Commercial Distribution

  • 00889795136817 ()
P11-854-C09S

  • Cannulated surgical drill bit, single-use
3.5 Hex Driver, Ball Nose, Short
Paragon 28, Inc.
P99-150-HB35-SHORT
In Commercial Distribution

  • 00889795136800 ()
P99-150-HB35-SHORT

  • Surgical screwdriver, reusable
3.5 Hex Driver, Ball Nose, Standard
Paragon 28, Inc.
P99-150-HB35
In Commercial Distribution

  • 00889795136794 ()
P99-150-HB35

  • Surgical screwdriver, reusable
Phantom Hindfoot Nail, Compression End Cap, Long
Paragon 28, Inc.
P31-111-0000-07
In Commercial Distribution

  • 00889795136558 ()
P31-111-0000-07

  • Bone nail end-cap
Phantom Hindfoot Nail, Compression End Cap, Short
Paragon 28, Inc.
P31-111-0000-03
In Commercial Distribution

  • 00889795136541 ()
P31-111-0000-03

  • Bone nail end-cap
Phantom Hindfoot Nail, Shouldered End Cap, Long
Paragon 28, Inc.
P31-102-0005
In Commercial Distribution

  • 00889795136534 ()
P31-102-0005

  • Bone nail end-cap
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