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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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Baby Gorilla®/Gorilla® Plating System - 00889795111197

Drill guide, EZ Cone Ø4.2mm, Long
Paragon 28, Inc.
P51-901-5042
In Commercial Distribution

  • 00889795111197 ()
P51-901-5042

  • Surgical drill guide, reusable

Baby Gorilla®/Gorilla® Plating System - 00889795111180

Drill Guide, EZ Cone Ø3.5mm, Long
Paragon 28, Inc.
P51-901-5035
In Commercial Distribution

  • 00889795111180 ()
P51-901-5035

  • Surgical drill guide, reusable

Baby Gorilla®/Gorilla® Plating System - 00889795111173

Drill Guide, EZ Cone Ø2.7mm, Long
Paragon 28, Inc.
P51-901-5027
In Commercial Distribution

  • 00889795111173 ()
P51-901-5027

  • Surgical drill guide, reusable

APEX 3D Total Ankle Replacement System - 00889795111166

Kocher Clamp, Straight, 1x2 Teeth, 160mm
Paragon 28, Inc.
P99-150-KC01
In Commercial Distribution

  • 00889795111166 ()
P99-150-KC01

  • Bone approximation clamp

APEX 3D Total Ankle Replacement System - 00889795111159

APEX 3D-PS Total Ankle Replacement System, Talar PSI Resection Block, Size 5
Paragon 28, Inc.
P10-944-PSI5
In Commercial Distribution

  • 00889795111159 ()
P10-944-PSI5

  • Osteotomy guide, reusable

Baby Gorilla®/Gorilla® Plating System - 00889795111142

Gorilla, R3con, Drill Guide Compression Slot, 4.2 Long
Paragon 28, Inc.
P51-903-3006
In Commercial Distribution

  • 00889795111142 ()
P51-903-3006

  • Surgical drill guide, reusable

Baby Gorilla®/Gorilla® Plating System - 00889795111135

Gorilla, R3con, Drill Guide Compression Slot, 3.5 Long
Paragon 28, Inc.
P51-903-3005
In Commercial Distribution

  • 00889795111135 ()
P51-903-3005

  • Surgical drill guide, reusable

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
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