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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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APEX 3D-PS Total Ankle Replacement System, Talar PSI Resection Block, Size 1 Narrow & 1
Paragon 28, Inc.
P10-944-PSI1
In Commercial Distribution

  • 00889795063625 ()
P10-944-PSI1

  • Osteotomy guide, reusable
APEX 3D-PS Total Ankle Replacement System, Anterior Chamfer Resection Insert, 2-Holed, Size 5
Paragon 28, Inc.
P10-944-LL25
In Commercial Distribution

  • 00889795063618 ()
P10-944-LL25

  • Orthopaedic reamer guide
APEX 3D-PS Total Ankle Replacement System, Anterior Chamfer Resection Insert, 2-Holed, Size 4
Paragon 28, Inc.
P10-944-LL24
In Commercial Distribution

  • 00889795063601 ()
P10-944-LL24

  • Orthopaedic reamer guide
APEX 3D-PS Total Ankle Replacement System, Anterior Chamfer Resection Insert, 2-Holed, Size 3
Paragon 28, Inc.
P10-944-LL23
In Commercial Distribution

  • 00889795063595 ()
P10-944-LL23

  • Orthopaedic reamer guide
APEX 3D-PS Total Ankle Replacement System, Anterior Chamfer Resection Insert, 2-Holed, Size 2
Paragon 28, Inc.
P10-944-LL22
In Commercial Distribution

  • 00889795063588 ()
P10-944-LL22

  • Orthopaedic reamer guide
APEX 3D-PS Total Ankle Replacement System, Anterior Chamfer Resection Insert, 2-Holed, Size 1
Paragon 28, Inc.
P10-944-LL21
In Commercial Distribution

  • 00889795063571 ()
P10-944-LL21

  • Orthopaedic reamer guide
APEX 3D-PS Total Ankle Replacement System, Anterior Chamfer Resection Insert, 2-Holed, Size 1 Narrow
Paragon 28, Inc.
P10-944-LL20
In Commercial Distribution

  • 00889795063564 ()
P10-944-LL20

  • Orthopaedic reamer guide
APEX 3D-PS Total Ankle Replacement System, Anterior Chamfer Resection Insert, Single-Slotted, Size 5
Paragon 28, Inc.
P10-944-LL15
In Commercial Distribution

  • 00889795063557 ()
P10-944-LL15

  • Orthopaedic reamer guide
APEX 3D-PS Total Ankle Replacement System, Anterior Chamfer Resection Insert, Single-Slotted, Size 4
Paragon 28, Inc.
P10-944-LL14
In Commercial Distribution

  • 00889795063540 ()
P10-944-LL14

  • Orthopaedic reamer guide
APEX 3D-PS Total Ankle Replacement System, Anterior Chamfer Resection Insert, Single-Slotted, Size 3
Paragon 28, Inc.
P10-944-LL13
In Commercial Distribution

  • 00889795063533 ()
P10-944-LL13

  • Orthopaedic reamer guide
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