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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PHANTOM Nail, 2.3mm K-Wire Tube
Paragon 28, Inc.
P30-000-KWT3
In Commercial Distribution

  • 00889795052483 ()
P30-000-KWT3

  • Device sterilization/disinfection container, reusable
PHANTOM Nail, 2.0mm K-Wire Tube
Paragon 28, Inc.
P30-000-KWT2
In Commercial Distribution

  • 00889795052476 ()
P30-000-KWT2

  • Device sterilization/disinfection container, reusable
PHANTOM Nail, 1.6mm K-Wire Tube
Paragon 28, Inc.
P30-000-KWT1
In Commercial Distribution

  • 00889795052469 ()
P30-000-KWT1

  • Device sterilization/disinfection container, reusable
PHANTOM Screw Caddy Base
Paragon 28, Inc.
P30-000-LSCB
In Commercial Distribution

  • 00889795052452 ()
P30-000-LSCB

  • Device sterilization/disinfection container, reusable
PHANTOM Screw Caddy Lid
Paragon 28, Inc.
P30-000-LSCL
In Commercial Distribution

  • 00889795052445 ()
P30-000-LSCL

  • Device sterilization/disinfection container, reusable
PHANTOM Nail Caddy Base
Paragon 28, Inc.
P30-000-LNCB
In Commercial Distribution

  • 00889795052438 ()
P30-000-LNCB

  • Device sterilization/disinfection container, reusable
PHANTOM Nail Caddy Lid
Paragon 28, Inc.
P30-000-LNCL
In Commercial Distribution

  • 00889795052421 ()
P30-000-LNCL

  • Device sterilization/disinfection container, reusable
PHANTOM Instrument Tray
Paragon 28, Inc.
P30-000-INST
In Commercial Distribution

  • 00889795052414 ()
P30-000-INST

  • Instrument tray, reusable
PHANTOM Case Base
Paragon 28, Inc.
P30-000-CASE
In Commercial Distribution

  • 00889795052391 ()
P30-000-CASE

  • Device sterilization/disinfection container, reusable
Driver, Cannulated, Hexalobe HX15
Paragon 28, Inc.
P99-190-TX15
In Commercial Distribution

  • 00889795052384 ()
P99-190-TX15

  • Surgical screwdriver, reusable
PROMO Placement Jig, Left
Paragon 28, Inc.
P51-908-L011
In Commercial Distribution

  • 00889795052377 ()
P51-908-L011

  • Orthopaedic prosthesis implantation positioning instrument, reusable
PROMO Placement Jig, Right
Paragon 28, Inc.
P51-908-R011
In Commercial Distribution

  • 00889795052360 ()
P51-908-R011

  • Orthopaedic prosthesis implantation positioning instrument, reusable
PROMO Rotation Jig
Paragon 28, Inc.
P51-908-0013
In Commercial Distribution

  • 00889795052353 ()
P51-908-0013

  • Orthopaedic prosthesis implantation positioning instrument, reusable
P28, Drill, Ø3.2mm x 18cm, Cann
Paragon 28, Inc.
P99-110-3218
In Commercial Distribution

  • 00889795052346 ()
P99-110-3218

  • Cannulated surgical drill bit, reusable
Gorilla, Calc Slide, Drill Guide, Swivel
Paragon 28, Inc.
P51-907-0006
In Commercial Distribution

  • 00889795052339 ()
P51-907-0006

  • Surgical drill guide, reusable
Monster BITE, Depth Gauge, K-wire measuring
Paragon 28, Inc.
P24-951-2027
In Commercial Distribution

  • 00889795052322 ()
P24-951-2027

  • Surgical depth gauge, reusable
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 left reamer template, Large
Paragon 28, Inc.
P51-111-L002
In Commercial Distribution

  • 00889795052049 ()
P51-111-L002

  • 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
General Tissue Protector, Jones Screw
Paragon 28, Inc.
P25-930-GEN1
In Commercial Distribution

  • 00889795051998 ()
P25-930-GEN1

  • Orthopaedic implantation sleeve, reusable
Anterior TT Plate, Standard, Contoured, Right, 08-Hole
Paragon 28, Inc.
P53-401-R101
In Commercial Distribution

  • 00889795051790 ()
P53-401-R101

  • Orthopaedic fixation plate, non-bioabsorbable, non-sterile
Anterior TT Plate, Standard, Flat, Left, 8-Hole
Paragon 28, Inc.
P53-401-L201
In Commercial Distribution

  • 00889795051783 ()
P53-401-L201

  • Orthopaedic fixation plate, non-bioabsorbable, non-sterile
Anterior TT Plate, Standard, Contoured, Left, 08-Hole
Paragon 28, Inc.
P53-401-L101
In Commercial Distribution

  • 00889795051776 ()
P53-401-L101

  • Orthopaedic fixation plate, non-bioabsorbable, non-sterile
ZigZag Plate, Spanning, 8 Hole, Large
Paragon 28, Inc.
P53-051-1017
In Commercial Distribution

  • 00889795051769 ()
P53-051-1017

  • Orthopaedic fixation plate, non-bioabsorbable, non-sterile
ZigZag Plate, Spanning, 8 Hole, Medium
Paragon 28, Inc.
P53-051-1015
In Commercial Distribution

  • 00889795051752 ()
P53-051-1015

  • Orthopaedic fixation plate, non-bioabsorbable, non-sterile
ZigZag Plate, Spanning, 8 Hole, Small
Paragon 28, Inc.
P53-051-1013
In Commercial Distribution

  • 00889795051745 ()
P53-051-1013

  • Orthopaedic fixation plate, non-bioabsorbable, non-sterile
ZigZag Plate, 19 Hole
Paragon 28, Inc.
P53-051-0019
In Commercial Distribution

  • 00889795051738 ()
P53-051-0019

  • Orthopaedic fixation plate, non-bioabsorbable, non-sterile
PROMO Plate, Countoured 6°, Right, Size 2
Paragon 28, Inc.
P53-014-R022
In Commercial Distribution

  • 00889795051721 ()
P53-014-R022

  • Orthopaedic fixation plate, non-bioabsorbable, non-sterile
PROMO Plate, Countoured 6°, Right, Size 1
Paragon 28, Inc.
P53-014-R021
In Commercial Distribution

  • 00889795051714 ()
P53-014-R021

  • Orthopaedic fixation plate, non-bioabsorbable, non-sterile
PROMO Plate, Countoured 6°, Left, Size 2
Paragon 28, Inc.
P53-014-L022
In Commercial Distribution

  • 00889795051707 ()
P53-014-L022

  • Orthopaedic fixation plate, non-bioabsorbable, non-sterile
PROMO Plate, Countoured 6°, Left, Size 1
Paragon 28, Inc.
P53-014-L021
In Commercial Distribution

  • 00889795051691 ()
P53-014-L021

  • Orthopaedic fixation plate, non-bioabsorbable, non-sterile
SILVERBACK Non-Locking Plate Screw, 5.2 x 60mm
Paragon 28, Inc.
P50-653-5260
In Commercial Distribution

  • 00889795051684 ()
P50-653-5260

  • Orthopaedic bone screw, non-bioabsorbable, non-sterile
SILVERBACK Non-Locking Plate Screw, 5.2 x 55mm
Paragon 28, Inc.
P50-653-5255
In Commercial Distribution

  • 00889795051677 ()
P50-653-5255

  • Orthopaedic bone screw, non-bioabsorbable, non-sterile
SILVERBACK Non-Locking Plate Screw, 5.2 x 50mm
Paragon 28, Inc.
P50-653-5250
In Commercial Distribution

  • 00889795051660 ()
P50-653-5250

  • Orthopaedic bone screw, non-bioabsorbable, non-sterile
SILVERBACK Non-Locking Plate Screw, 5.2 x 48mm
Paragon 28, Inc.
P50-653-5248
In Commercial Distribution

  • 00889795051653 ()
P50-653-5248

  • Orthopaedic bone screw, non-bioabsorbable, non-sterile
SILVERBACK Non-Locking Plate Screw, 5.2 x 46mm
Paragon 28, Inc.
P50-653-5246
In Commercial Distribution

  • 00889795051646 ()
P50-653-5246

  • Orthopaedic bone screw, non-bioabsorbable, non-sterile
SILVERBACK Non-Locking Plate Screw, 5.2 x 44mm
Paragon 28, Inc.
P50-653-5244
In Commercial Distribution

  • 00889795051639 ()
P50-653-5244

  • Orthopaedic bone screw, non-bioabsorbable, non-sterile
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