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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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Phantom Screw Driver Attachment, Cannulated, 3/16" Sq. Connection, TX-30 x 85mm
Paragon 28, Inc.
P31-190-TX30-09
In Commercial Distribution

  • 00889795098146 ()
P31-190-TX30-09

  • Bone nail driver
Screw Driver Attachment, Solid, 3/16" Sq. Connection, TX-20 x 160mm
Paragon 28, Inc.
P99-191-TX20-16
In Commercial Distribution

  • 00889795098139 ()
P99-191-TX20-16

  • Bone nail driver
Phantom Hindfoot Depth Gauge, Cannulated
Paragon 28, Inc.
P31-957-0002
In Commercial Distribution

  • 00889795098122 ()
P31-957-0002

  • Surgical depth gauge, reusable
Phantom Hindfoot Depth Gauge, Solid
Paragon 28, Inc.
P31-957-0001
In Commercial Distribution

  • 00889795098115 ()
P31-957-0001

  • Surgical depth gauge, reusable
Drill, 3.8 X 250mm Drill, Solid, Trocar Tip, 3/16" Sq. Connection
Paragon 28, Inc.
P99-100-3825
In Commercial Distribution

  • 00889795098108 ()
P99-100-3825

  • Fluted surgical drill bit, single-use
Phantom ActivCore Nail, 10.0 X 200mm
Paragon 28, Inc.
P31-102-2000-S
In Commercial Distribution

  • 00889795097712 ()
P31-102-2000-S

  • Arthrodesis intramedullary nail, non-distracting
Phantom TC Nail, 13.0 X 250mm
Paragon 28, Inc.
P31-430-2500-S
In Commercial Distribution

  • 00889795097699 ()
P31-430-2500-S

  • Arthrodesis intramedullary nail, non-distracting
APEX 3D™ Tibia, Flat, Right, Size 6, Standard, 3DP
Paragon 28, Inc.
P10-101-BR6S-S
In Commercial Distribution

  • 00889795097538 ()
P10-101-BR6S-S

  • Fixed-bearing total ankle prosthesis
APEX 3D™ Tibia, Arc, Right, Size 6, Standard, 3DP
Paragon 28, Inc.
P10-100-BR6S-S
In Commercial Distribution

  • 00889795097514 ()
P10-100-BR6S-S

  • Fixed-bearing total ankle prosthesis
AVITRAC™ Core, MTP Reamer, Ø13 mm
Paragon 28, Inc.
P01-901-1301
In Commercial Distribution

  • 00889795097491 ()
P01-901-1301

  • Bone-resection orthopaedic reamer, reusable
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