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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 S Total Ankle Replacement System - 00889795136824

Short Stem Tibia, Instrument, Drill Bit Cap D9, Tall
Paragon 28, Inc.
P11-854-C09T
In Commercial Distribution

  • 00889795136824 ()
P11-854-C09T

  • Cannulated surgical drill bit, single-use

APEX 3D S Total Ankle Replacement System - 00889795136817

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

APEX 3D Total Ankle Replacement System - 00889795136800

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

APEX 3D Total Ankle Replacement System - 00889795136794

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

  • 00889795136794 ()
P99-150-HB35

  • Surgical screwdriver, reusable

Phantom® Fibula Nail System - 00889795135001

Small Mallet
Paragon 28, Inc.
P36-970-0002
In Commercial Distribution

  • 00889795135001 ()
P36-970-0002

  • Surgical mallet

Phantom® Fibula Nail System - 00889795134981

T25 Hexalobe Driver, AO Quick Connect
Paragon 28, Inc.
P36-940-TT25
In Commercial Distribution

  • 00889795134981 ()
P36-940-TT25

  • Surgical screwdriver, reusable

Phantom® Fibula Nail System - 00889795134974

T10 Hexalobe Driver, Calibrated, AO Quick Connect
Paragon 28, Inc.
P36-940-TT10
In Commercial Distribution

  • 00889795134974 ()
P36-940-TT10

  • Surgical screwdriver, reusable

Phantom® Fibula Nail System - 00889795133854

Actuation Driver, 2.0mm Hex, Sterile
Paragon 28, Inc.
P36-940-0001-S
Not in Commercial Distribution

  • 00889795133854 ()
P36-940-0001-S

  • Surgical screwdriver, single-use

Precision MIS Bunion System - 00889795132673

Ø4.0 Driver, Solid, Short
Paragon 28, Inc.
P27-191-TT40
In Commercial Distribution

  • 00889795132673 ()
P27-191-TT40

  • Surgical screwdriver, reusable

APEX 3D Total Ankle Replacement System - 00889795132321

3.5MM Square Tip, 13 CM, Total Ankle Tibia Drill
Paragon 28, Inc.
P10-842-35SQ
In Commercial Distribution

  • 00889795132321 ()
P10-842-35SQ

  • Cannulated surgical drill bit, single-use
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