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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 Total Ankle Replacement System - 00889795064110

Steinmann Pin, 316LVM, Smooth, Ø2.4x110mm
Paragon 28, Inc.
P99-160-2411
In Commercial Distribution

  • 00889795064110 ()
P99-160-2411

  • Orthopaedic bone wire

APEX 3D Total Ankle Replacement System - 00889795064103

3.5MM Hex Screw Driver, 225mm Length
Paragon 28, Inc.
P99-150-HX35
In Commercial Distribution

  • 00889795064103 ()
P99-150-HX35

  • Surgical screwdriver, reusable

APEX 3D Total Ankle Replacement System - 00889795064097

Rasp, General
Paragon 28, Inc.
P99-150-0105
In Commercial Distribution

  • 00889795064097 ()
P99-150-0105

  • Bone file/rasp, manual, reusable

APEX 3D Total Ankle Replacement System - 00889795064080

APEX 3D-PS Total Ankle Replacement System, Talus Trial Handling Tool
Paragon 28, Inc.
P10-953-TL01
In Commercial Distribution

  • 00889795064080 ()
P10-953-TL01

  • Surgical instrument handle, non-torque-limiting

APEX 3D Total Ankle Replacement System - 00889795064073

APEX 3D-PS Total Ankle Replacement System, Poly Trial Handling Tool
Paragon 28, Inc.
P10-953-IN01
In Commercial Distribution

  • 00889795064073 ()
P10-953-IN01

  • Surgical instrument handle, non-torque-limiting

APEX 3D Total Ankle Replacement System - 00889795064066

APEX 3D-PS Total Ankle Replacement System, Talus Impaction Handle
Paragon 28, Inc.
P10-952-TL00
In Commercial Distribution

  • 00889795064066 ()
P10-952-TL00

  • Surgical instrument handle, non-torque-limiting

APEX 3D Total Ankle Replacement System - 00889795064059

APEX 3D-PS Total Ankle Replacement System, Tibia Impaction Peg Punch, Right, Size 6
Paragon 28, Inc.
P10-951-TPR6
In Commercial Distribution

  • 00889795064059 ()
P10-951-TPR6

  • Bone-coring punch, reusable

APEX 3D Total Ankle Replacement System - 00889795064042

APEX 3D-PS Total Ankle Replacement System, Tibia Impaction Peg Punch, Right, Size 5
Paragon 28, Inc.
P10-951-TPR5
In Commercial Distribution

  • 00889795064042 ()
P10-951-TPR5

  • Bone-coring punch, reusable

APEX 3D Total Ankle Replacement System - 00889795064035

APEX 3D-PS Total Ankle Replacement System, Tibia Impaction Peg Punch, Right, Size 4
Paragon 28, Inc.
P10-951-TPR4
In Commercial Distribution

  • 00889795064035 ()
P10-951-TPR4

  • Bone-coring punch, reusable

APEX 3D Total Ankle Replacement System - 00889795064028

APEX 3D-PS Total Ankle Replacement System, Tibia Impaction Peg Punch, Right, Size 3
Paragon 28, Inc.
P10-951-TPR3
In Commercial Distribution

  • 00889795064028 ()
P10-951-TPR3

  • Bone-coring punch, reusable
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