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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 - 00889795111128

APEX 3D-PS Total Ankle Replacement System, Talar PSI Resection Block, Size 4
Paragon 28, Inc.
P10-944-PSI4
In Commercial Distribution

  • 00889795111128 ()
P10-944-PSI4

  • Osteotomy guide, reusable

APEX 3D Total Ankle Replacement System - 00889795111111

APEX 3D-PS Total Ankle Replacement System, Talar PSI Resection Block, Size 1 Narrow
Paragon 28, Inc.
P10-944-PSI0
In Commercial Distribution

  • 00889795111111 ()
P10-944-PSI0

  • Osteotomy guide, reusable

APEX 3D Total Ankle Replacement System - 00889795111104

Total Ankle, Revision Poly Caddy
Paragon 28, Inc.
P10-900-RVNP
In Commercial Distribution

  • 00889795111104 ()
P10-900-RVNP

  • Device sterilization/disinfection container, reusable

Baby Gorilla®/Gorilla® Plating System - 00889795111098

Gorilla, R3con, Drill Guide Compression Slot, 2.7 Long
Paragon 28, Inc.
P51-903-3004
In Commercial Distribution

  • 00889795111098 ()
P51-903-3004

  • Surgical drill guide, reusable

APEX 3D Total Ankle Replacement System - 00889795111067

Laser Alignment Guide
Paragon 28, Inc.
P10-941-LAZM
In Commercial Distribution

  • 00889795111067 ()
P10-941-LAZM

  • Orthopaedic fixation implant alignment tool

MgNum - 00889795111005

MgNum, Bone Void Filler, Mixing and Delivery System
Paragon 28, Inc.
P02-BVF-AUX1
In Commercial Distribution

  • 00889795111005 ()
P02-BVF-AUX1

  • Bone graft delivery kit

MgNum - 00889795110992

MgNum, Bone Void Filler, 15cc
Paragon 28, Inc.
P02-BVF-0015
In Commercial Distribution

  • 00889795110992 ()
P02-BVF-0015

  • Bone matrix implant, synthetic, non-antimicrobial

MgNum - 00889795110985

MgNum, Bone Void Filler, 10cc
Paragon 28, Inc.
P02-BVF-0010
In Commercial Distribution

  • 00889795110985 ()
P02-BVF-0010

  • Bone matrix implant, synthetic, non-antimicrobial

MgNum - 00889795110978

MgNum, Bone Void Filler, 5cc
Paragon 28, Inc.
P02-BVF-0005
In Commercial Distribution

  • 00889795110978 ()
P02-BVF-0005

  • Bone matrix implant, synthetic, non-antimicrobial

APEX 3D Total Ankle Replacement System - 00889795110961

HEX SCREW DRIVER, SHORT, 3.5mm X 155mm
Paragon 28, Inc.
P99-150-HX35-SHORT
In Commercial Distribution

  • 00889795110961 ()
P99-150-HX35-SHORT

  • Surgical screwdriver, reusable
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