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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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Monster Screw System - 00889795040565

Over Drill, 2.0 x 110mm, Cannulated, AO
Paragon 28, Inc.
P99-110-2011
In Commercial Distribution

  • 00889795040565 ()
P99-110-2011

  • Cannulated surgical drill bit, single-use

Monster Screw System - 00889795040558

Drill, 1.7 x 120mm, Cannulated, AO
Paragon 28, Inc.
P99-110-1712
In Commercial Distribution

  • 00889795040558 ()
P99-110-1712

  • Cannulated surgical drill bit, single-use

JAWS Nitinol Staple System - 00889795040336

Straight Staple Assembly, 20 x 20mm
Paragon 28, Inc.
P71-020-2020-S
In Commercial Distribution

  • 00889795040336 ()
P71-020-2020-S

  • Orthopaedic bone staple, non-adjustable

JAWS Nitinol Staple System - 00889795040312

Straight Staple Assembly, 18 x 18mm
Paragon 28, Inc.
P71-018-1818-S
In Commercial Distribution

  • 00889795040312 ()
P71-018-1818-S

  • Orthopaedic bone staple, non-adjustable

JAWS Nitinol Staple System - 00889795040305

Straight Staple Assembly, 15 x 15mm
Paragon 28, Inc.
P71-015-1515-S
In Commercial Distribution

  • 00889795040305 ()
P71-015-1515-S

  • Orthopaedic bone staple, non-adjustable

Baby Gorilla®/Gorilla® Plating System - 00889795040022

Lapidus Precision™ Guide, Right
Paragon 28, Inc.
P51-950-R106
In Commercial Distribution

  • 00889795040022 ()
P51-950-R106

  • Orthopaedic prosthesis implantation positioning instrument, reusable

Baby Gorilla®/Gorilla® Plating System - 00889795040015

Lapidus Precision™ Guide, Left
Paragon 28, Inc.
P51-950-L106
In Commercial Distribution

  • 00889795040015 ()
P51-950-L106

  • Orthopaedic prosthesis implantation positioning instrument, reusable

Baby Gorilla®/Gorilla® Plating System - 00889795040008

Gorilla, Precision™ Guide, Straddle, Guide Jig
Paragon 28, Inc.
P51-950-0109
In Commercial Distribution

  • 00889795040008 ()
P51-950-0109

  • Orthopaedic prosthesis implantation positioning instrument, reusable

Baby Gorilla®/Gorilla® Plating System - 00889795039996

MTP Precision™ Guide
Paragon 28, Inc.
P51-950-0103
In Commercial Distribution

  • 00889795039996 ()
P51-950-0103

  • Orthopaedic prosthesis implantation positioning instrument, reusable

Baby Gorilla®/Gorilla® Plating System - 00889795039958

LCF K-Wire Aiming Guide
Paragon 28, Inc.
P51-924-0002
In Commercial Distribution

  • 00889795039958 ()
P51-924-0002

  • Orthopaedic prosthesis implantation positioning instrument, reusable
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