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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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Grappler Suture Anchor System - 00889795128003

Grappler ExO R3INFORCE, ø4.2mm x 12mm Locking Anchor, Sterile Kit
Paragon 28, Inc.
P82-220-4212-SK
In Commercial Distribution

  • 00889795128003 ()
P82-220-4212-SK

  • General internal orthopaedic fixation system implantation kit

Baby Gorilla®/Gorilla® Plating System - 00889795127945

1/3 Tubular Plate, 2 Hole
Paragon 28, Inc.
P53-201-1002
In Commercial Distribution

  • 00889795127945 ()
P53-201-1002

  • Orthopaedic fixation plate, non-bioabsorbable

Monkey Rings™ External Fixation System - 00889795126801

Half Pin, Self Drilling, Ø6.0 X 35mm, 130mm Shank Length, HA Coated
Paragon 28, Inc.
P45-199-6035-S
In Commercial Distribution

  • 00889795126801 ()
P45-199-6035-S

  • External orthopaedic fixation system, single-use

Monkey Rings™ External Fixation System - 00889795126795

Half Pin, Self Drilling, Ø6.0 X 30mm, 130mm Shank Length, HA Coated
Paragon 28, Inc.
P45-199-6030-S
In Commercial Distribution

  • 00889795126795 ()
P45-199-6030-S

  • External orthopaedic fixation system, single-use

Monkey Rings™ External Fixation System - 00889795126788

Half Pin, Self Drilling, Ø5.0 X 35mm, 130mm Shank Length, HA Coated
Paragon 28, Inc.
P45-199-5035-S
In Commercial Distribution

  • 00889795126788 ()
P45-199-5035-S

  • External orthopaedic fixation system, single-use

Monkey Rings™ External Fixation System - 00889795126771

Half Pin, Self Drilling, Ø5.0 X 30mm, 130mm Shank Length, HA Coated
Paragon 28, Inc.
P45-199-5030-S
In Commercial Distribution

  • 00889795126771 ()
P45-199-5030-S

  • External orthopaedic fixation system, single-use

Baby Gorilla®/Gorilla® Plating System - 00889795124586

Gorilla, SMO, Case Base
Paragon 28, Inc.
P50-900-SMCB
In Commercial Distribution

  • 00889795124586 ()
P50-900-SMCB

  • Device sterilization/disinfection container, reusable

APEX 3D Total Ankle Replacement System - 00889795124579

Total Ankle, Instrument, Fluted Single Peg Punch, Right
Paragon 28, Inc.
P10-851-R001
In Commercial Distribution

  • 00889795124579 ()
P10-851-R001

  • Bone-coring punch, reusable

APEX 3D Total Ankle Replacement System - 00889795124562

Total Ankle, Instrument, Fluted Single Peg Punch, Left
Paragon 28, Inc.
P10-851-L001
In Commercial Distribution

  • 00889795124562 ()
P10-851-L001

  • Bone-coring punch, reusable

Monkey Rings™ External Fixation System - 00889795124555

Bevel Nut, 10mm
Paragon 28, Inc.
P45-940-1001
In Commercial Distribution

  • 00889795124555 ()
P45-940-1001

  • External orthopaedic fixation system, single-use
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