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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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Lower Gorilla Instrument Tray, Stainless
Paragon 28, Inc.
P50-900-5005
In Commercial Distribution

  • 00889795052308 ()
P50-900-5005

  • Device sterilization/disinfection container, reusable
Upper Gorilla Instrument Tray, Stainless
Paragon 28, Inc.
P50-900-5004
In Commercial Distribution

  • 00889795052292 ()
P50-900-5004

  • Device sterilization/disinfection container, reusable
Outer Caddy Base Assembly, Stainless
Paragon 28, Inc.
P50-900-5003
In Commercial Distribution

  • 00889795052285 ()
P50-900-5003

  • Device sterilization/disinfection container, reusable
Outer Caddy Base, Stainless
Paragon 28, Inc.
P50-900-5002
In Commercial Distribution

  • 00889795052278 ()
P50-900-5002

  • Device sterilization/disinfection container, reusable
Outer Caddy Lid, Stainless
Paragon 28, Inc.
P50-900-5001
In Commercial Distribution

  • 00889795052261 ()
P50-900-5001

  • Device sterilization/disinfection container, reusable
Gorilla, R3CON Screw, Ø3.5 x 70mm, Non-Locking, Solid, TiA
Paragon 28, Inc.
P50-453-3570
In Commercial Distribution

  • 00889795052254 ()
P50-453-3570

  • Orthopaedic bone screw, non-bioabsorbable, non-sterile
Gorilla, R3CON Screw, Ø3.5 x 65mm, Non-Locking, Solid, TiA
Paragon 28, Inc.
P50-453-3565
In Commercial Distribution

  • 00889795052247 ()
P50-453-3565

  • Orthopaedic bone screw, non-bioabsorbable, non-sterile
P28, Driver, Solid, TX 25, AO, SS
Paragon 28, Inc.
P99-191-LC25
In Commercial Distribution

  • 00889795052186 ()
P99-191-LC25

  • Surgical screwdriver, reusable
Ø5.5 Depth Gauge, Lateral Column Fusion
Paragon 28, Inc.
P51-924-0006
In Commercial Distribution

  • 00889795052179 ()
P51-924-0006

  • Surgical depth gauge, reusable
Phantom Nail, Crossing Screw, Ø5.0mm x 20mm length, Headed
Paragon 28, Inc.
P32-450-020F
In Commercial Distribution

  • 00889795052155 ()
P32-450-020F

  • Orthopaedic bone screw, non-bioabsorbable, non-sterile
Phantom Nail, Left, 3 Hole, Ø5.5mm x 38mm
Paragon 28, Inc.
P30-L2-5538
In Commercial Distribution

  • 00889795052094 ()
P30-L2-5538

  • Arthrodesis intramedullary nail, non-distracting
Gorilla, Precision Guide, Straddle, Guide Jig, U-Configuration
Paragon 28, Inc.
P51-950-1109-01
In Commercial Distribution

  • 00889795052087 ()
P51-950-1109-01

  • Orthopaedic prosthesis implantation positioning instrument, reusable
Driver, Cannulated, Hexalobe HX6 Modified
Paragon 28, Inc.
P99-190-TX06
In Commercial Distribution

  • 00889795052070 ()
P99-190-TX06

  • Surgical screwdriver, reusable
Lateral Column fusion right reamer template, Large
Paragon 28, Inc.
P51-111-R002
In Commercial Distribution

  • 00889795052063 ()
P51-111-R002

  • Surgical implant template, reusable
Lateral Column fusion right reamer template, Standard
Paragon 28, Inc.
P51-111-R001
In Commercial Distribution

  • 00889795052056 ()
P51-111-R001

  • Surgical implant template, reusable
Lateral Column fusion left reamer template, Large
Paragon 28, Inc.
P51-111-L002
In Commercial Distribution

  • 00889795052049 ()
P51-111-L002

  • Surgical implant template, reusable
Lateral Column fusion left reamer template, Standard
Paragon 28, Inc.
P51-111-L001
In Commercial Distribution

  • 00889795052032 ()
P51-111-L001

  • Surgical implant template, reusable
Drill, 2.8mm x 180mm, Cannulated, AO
Paragon 28, Inc.
P99-110-2818
In Commercial Distribution

  • 00889795052018 ()
P99-110-2818

  • Cannulated surgical drill bit, reusable
Drill, 3.8mm x 180mm, Cannulated, AO
Paragon 28, Inc.
P99-110-3818
In Commercial Distribution

  • 00889795052001 ()
P99-110-3818

  • Cannulated surgical drill bit, reusable
General Tissue Protector, Jones Screw
Paragon 28, Inc.
P25-930-GEN1
In Commercial Distribution

  • 00889795051998 ()
P25-930-GEN1

  • Orthopaedic implantation sleeve, reusable
Silverback, Driver Solid HX15 X 83MM SS
Paragon 28, Inc.
P99-191-SB15
In Commercial Distribution

  • 00889795051981 ()
P99-191-SB15

  • Surgical screwdriver, reusable
SILVERBACK Gorilla, Plate Washer
Paragon 28, Inc.
P50-553-SB01
In Commercial Distribution

  • 00889795051974 ()
P50-553-SB01

  • Implantable bone washer
Gorilla, Precision Guide, Threaded Adjustment Knob
Paragon 28, Inc.
P51-950-0005
In Commercial Distribution

  • 00889795051929 ()
P51-950-0005

  • Surgical instrument handle, non-torque-limiting
5th Met, Hook Screw, Drill Guide
Paragon 28, Inc.
P51-921-0009
In Commercial Distribution

  • 00889795051912 ()
P51-921-0009

  • Surgical drill guide, reusable
5th Met, Plate Template, 5 Hole, Right
Paragon 28, Inc.
P51-921-R005
In Commercial Distribution

  • 00889795051905 ()
P51-921-R005

  • Surgical implant template, reusable
5th Met, Plate Template, 5 Hole, Left
Paragon 28, Inc.
P51-921-L005
In Commercial Distribution

  • 00889795051899 ()
P51-921-L005

  • Surgical implant template, reusable
5th Met, Plate Template, 6 Hole, Right
Paragon 28, Inc.
P51-921-R006
In Commercial Distribution

  • 00889795051882 ()
P51-921-R006

  • Surgical implant template, reusable
5th Met, Plate Template, 6 Hole, Left
Paragon 28, Inc.
P51-921-L006
In Commercial Distribution

  • 00889795051875 ()
P51-921-L006

  • Surgical implant template, reusable
Morselizing Bone Graft Harvester, AO, 10mm
Paragon 28, Inc.
P99-930-2110
In Commercial Distribution

  • 00889795051868 ()
P99-930-2110

  • Cannulated surgical drill bit, single-use
Morselizing Bone Graft Harvester, Door, 12mm
Paragon 28, Inc.
P99-930-2010
In Commercial Distribution

  • 00889795051851 ()
P99-930-2010

  • Orthopaedic surgery tissue debris collector, reusable
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