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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 - 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

Lesser Metatarsal Shortening System - 00889795111029

Saw Blade 9 x 31 x .051mm Stryker (Sterile)
Paragon 28, Inc.
P99-151-P30S-1-S
In Commercial Distribution

  • 00889795111029 ()
P99-151-P30S-1-S

  • Surgical saw blade, oscillating, single-use

Lesser Metatarsal Shortening System - 00889795111012

Saw Blade 9 x 31 x .051mm, MicroAire (Sterile)
Paragon 28, Inc.
P99-151-P30M-1-S
In Commercial Distribution

  • 00889795111012 ()
P99-151-P30M-1-S

  • Surgical saw blade, oscillating, single-use

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

Baby Gorilla®/Gorilla® Plating System - 00889795110954

Screw Retention Sleeve
Paragon 28, Inc.
P99-191-SL10
In Commercial Distribution

  • 00889795110954 ()
P99-191-SL10

  • Orthopaedic implantation sleeve, reusable

Baby Gorilla®/Gorilla® Plating System - 00889795110947

Gorilla, Ankle Fx, Threaded Positioning Tower, LONG
Paragon 28, Inc.
P51-900-2002
In Commercial Distribution

  • 00889795110947 ()
P51-900-2002

  • Surgical drill guide, reusable

Baby Gorilla®/Gorilla® Plating System - 00889795110930

Ø3.5 x 13cm Solid Over Drill
Paragon 28, Inc.
P99-100-3513
In Commercial Distribution

  • 00889795110930 ()
P99-100-3513

  • Cannulated surgical drill bit, reusable

Baby Gorilla®/Gorilla® Plating System - 00889795110923

Ø2.0 x 14cm Solid Drill
Paragon 28, Inc.
P99-100-2013
In Commercial Distribution

  • 00889795110923 ()
P99-100-2013

  • Cannulated surgical drill bit, reusable
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