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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T-Handle, AO and 10mm Socket
Paragon 28, Inc.
P47-940-0001
In Commercial Distribution

  • 00889795145956 ()
P47-940-0001

  • Surgical instrument handle, non-torque-limiting
5mm Trocar
Paragon 28, Inc.
P47-930-0001
In Commercial Distribution

  • 00889795145949 ()
P47-930-0001

  • Orthopaedic prosthesis implantation positioning instrument, reusable
Fixation Pin Drill Sleeve
Paragon 28, Inc.
P47-920-0001
In Commercial Distribution

  • 00889795145932 ()
P47-920-0001

  • Orthopaedic implantation sleeve, reusable
Fixation Pin Drill Sleeve w/ Handle
Paragon 28, Inc.
P47-910-0001
In Commercial Distribution

  • 00889795145925 ()
P47-910-0001

  • Orthopaedic implantation sleeve, reusable
Step Drill, 4.0 x 200mm
Paragon 28, Inc.
P47-100-4020
In Commercial Distribution

  • 00889795145918 ()
P47-100-4020

  • Fluted surgical drill bit, reusable
Step Drill, 3.2 x 165mm
Paragon 28, Inc.
P47-100-3216
In Commercial Distribution

  • 00889795145901 ()
P47-100-3216

  • Fluted surgical drill bit, reusable
Step Drill, 2.4 x 140mm
Paragon 28, Inc.
P47-100-2414
In Commercial Distribution

  • 00889795145895 ()
P47-100-2414

  • Fluted surgical drill bit, reusable
30 Degree Post
Paragon 28, Inc.
P47-510-P030
In Commercial Distribution

  • 00889795145888 ()
P47-510-P030

  • External orthopaedic fixation system, single-use
Straight Post
Paragon 28, Inc.
P47-510-P000
In Commercial Distribution

  • 00889795145871 ()
P47-510-P000

  • External orthopaedic fixation system, single-use
Ankle Fracture 360, 2.7/3.5 mm Screw Caddy, Base
Paragon 28, Inc.
P50-900-2735-1
In Commercial Distribution

  • 00889795145864 ()
P50-900-2735-1

  • Device sterilization/disinfection container, reusable
Carbon Bar, 11mm x 500mm
Paragon 28, Inc.
P47-410-0500
In Commercial Distribution

  • 00889795145840 ()
P47-410-0500

  • External orthopaedic fixation system, single-use
Carbon Bar, 11mm x 450mm
Paragon 28, Inc.
P47-410-0450
In Commercial Distribution

  • 00889795145833 ()
P47-410-0450

  • External orthopaedic fixation system, single-use
Carbon Bar, 11mm x 400mm
Paragon 28, Inc.
P47-410-0400
In Commercial Distribution

  • 00889795145826 ()
P47-410-0400

  • External orthopaedic fixation system, single-use
Carbon Bar, 11mm x 350mm
Paragon 28, Inc.
P47-410-0350
In Commercial Distribution

  • 00889795145819 ()
P47-410-0350

  • External orthopaedic fixation system, single-use
Carbon Bar, 11mm x 300mm
Paragon 28, Inc.
P47-410-0300
In Commercial Distribution

  • 00889795145802 ()
P47-410-0300

  • External orthopaedic fixation system, single-use
Carbon Bar, 11mm x 250mm
Paragon 28, Inc.
P47-410-0250
In Commercial Distribution

  • 00889795145796 ()
P47-410-0250

  • External orthopaedic fixation system, single-use
Carbon Bar, 11mm x 200mm
Paragon 28, Inc.
P47-410-0200
In Commercial Distribution

  • 00889795145789 ()
P47-410-0200

  • External orthopaedic fixation system, single-use
Carbon Bar, 11mm x 150mm
Paragon 28, Inc.
P47-410-0150
In Commercial Distribution

  • 00889795145772 ()
P47-410-0150

  • External orthopaedic fixation system, single-use
8-Pin Multi Pin Clamp
Paragon 28, Inc.
P47-320-0008
In Commercial Distribution

  • 00889795145765 ()
P47-320-0008

  • External orthopaedic fixation system, single-use
5-Pin Multi Pin Clamp
Paragon 28, Inc.
P47-320-0005
In Commercial Distribution

  • 00889795145758 ()
P47-320-0005

  • External orthopaedic fixation system, single-use
Transfixation Pin, 5 x 325mm, Centrally Threaded
Paragon 28, Inc.
P47-220-5325
In Commercial Distribution

  • 00889795145734 ()
P47-220-5325

  • External orthopaedic fixation system, single-use
Half Pin, 5 x 65mm, Blunt-Tipped
Paragon 28, Inc.
P47-210-565B
In Commercial Distribution

  • 00889795145727 ()
P47-210-565B

  • External orthopaedic fixation system, single-use
Half Pin, 5 x 65mm, Self-Tapping
Paragon 28, Inc.
P47-210-565S
In Commercial Distribution

  • 00889795145710 ()
P47-210-565S

  • External orthopaedic fixation system, single-use
Half Pin, 5 x 55mm, Blunt-Tipped
Paragon 28, Inc.
P47-210-555B
In Commercial Distribution

  • 00889795145703 ()
P47-210-555B

  • External orthopaedic fixation system, single-use
Half Pin, 5 x 55mm, Self-Tapping
Paragon 28, Inc.
P47-210-555S
In Commercial Distribution

  • 00889795145697 ()
P47-210-555S

  • External orthopaedic fixation system, single-use
Half Pin, 5 x 45mm, Blunt-Tipped
Paragon 28, Inc.
P47-210-545B
In Commercial Distribution

  • 00889795145680 ()
P47-210-545B

  • External orthopaedic fixation system, single-use
Half Pin, 5 x 45mm, Self-Tapping
Paragon 28, Inc.
P47-210-545S
In Commercial Distribution

  • 00889795145673 ()
P47-210-545S

  • External orthopaedic fixation system, single-use
Half Pin, 5 x 35mm, Blunt-Tipped
Paragon 28, Inc.
P47-210-535B
In Commercial Distribution

  • 00889795145666 ()
P47-210-535B

  • External orthopaedic fixation system, single-use
Half Pin, 5 x 35mm, Self-Tapping
Paragon 28, Inc.
P47-210-535S
In Commercial Distribution

  • 00889795145659 ()
P47-210-535S

  • External orthopaedic fixation system, single-use
Half Pin, 4 x 30mm, Blunt-Tipped
Paragon 28, Inc.
P47-210-430B
In Commercial Distribution

  • 00889795145642 ()
P47-210-430B

  • External orthopaedic fixation system, single-use
Half Pin, 4 x 30mm, Self-Tapping
Paragon 28, Inc.
P47-210-430S
In Commercial Distribution

  • 00889795145635 ()
P47-210-430S

  • External orthopaedic fixation system, single-use
Half Pin, 4 x 20mm, Blunt-Tipped
Paragon 28, Inc.
P47-210-420B
In Commercial Distribution

  • 00889795145628 ()
P47-210-420B

  • External orthopaedic fixation system, single-use
Half Pin, 4 x 20mm, Self-Tapping
Paragon 28, Inc.
P47-210-420S
In Commercial Distribution

  • 00889795145611 ()
P47-210-420S

  • External orthopaedic fixation system, single-use
Half Pin, 3 x 20mm, Blunt-Tipped
Paragon 28, Inc.
P47-210-320B
In Commercial Distribution

  • 00889795145604 ()
P47-210-320B

  • External orthopaedic fixation system, single-use
Half Pin, 3 x 20mm, Self-Tapping
Paragon 28, Inc.
P47-210-320S
In Commercial Distribution

  • 00889795145598 ()
P47-210-320S

  • External orthopaedic fixation system, single-use
Gorilla®, R3CON™ Screw, Ø2.7 x 80mm, Non-Locking, Solid, TiA
Paragon 28, Inc.
P50-453-2780
In Commercial Distribution

  • 00889795145574 ()
P50-453-2780

  • Orthopaedic bone screw (non-sliding)
Gorilla®, R3CON™ Screw, Ø2.7 x 75mm, Non-Locking, Solid, TiA
Paragon 28, Inc.
P50-453-2775
In Commercial Distribution

  • 00889795145567 ()
P50-453-2775

  • Orthopaedic bone screw (non-sliding)
Gorilla®, R3CON™ Screw, Ø2.7 x 70mm, Non-Locking, Solid, TiA
Paragon 28, Inc.
P50-453-2770
In Commercial Distribution

  • 00889795145550 ()
P50-453-2770

  • Orthopaedic bone screw (non-sliding)
Gorilla®, R3CON™ Screw, Ø2.7 x 68mm, Non-Locking, Solid, TiA
Paragon 28, Inc.
P50-453-2768
In Commercial Distribution

  • 00889795145543 ()
P50-453-2768

  • Orthopaedic bone screw (non-sliding)
Gorilla®, R3CON™ Screw, Ø2.7 x 66mm, Non-Locking, Solid, TiA
Paragon 28, Inc.
P50-453-2766
In Commercial Distribution

  • 00889795145536 ()
P50-453-2766

  • Orthopaedic bone screw (non-sliding)
Gorilla®, R3CON™ Screw, Ø2.7 x 65mm, Non-Locking, Solid, TiA
Paragon 28, Inc.
P50-453-2765
In Commercial Distribution

  • 00889795145529 ()
P50-453-2765

  • Orthopaedic bone screw (non-sliding)
Gorilla®, R3CON™ Screw, Ø2.7 x 64mm, Non-Locking, Solid, TiA
Paragon 28, Inc.
P50-453-2764
In Commercial Distribution

  • 00889795145512 ()
P50-453-2764

  • Orthopaedic bone screw (non-sliding)
Gorilla®, R3CON™ Screw, Ø2.7 x 62mm, Non-Locking, Solid, TiA
Paragon 28, Inc.
P50-453-2762
In Commercial Distribution

  • 00889795145505 ()
P50-453-2762

  • Orthopaedic bone screw (non-sliding)
Drill Guide Sleeve, 4.2mm, R3CON
Paragon 28, Inc.
P51-913-2842-03
In Commercial Distribution

  • 00889795145499 ()
P51-913-2842-03

  • Surgical drill guide, reusable
Ovr Dr Gd, Dbl End, 2.8/4.2mm, R3CON
Paragon 28, Inc.
P51-913-2842
In Commercial Distribution

  • 00889795145482 ()
P51-913-2842

  • Surgical drill guide, reusable
Drl Gd Slv, 3.5mm, R3CON
Paragon 28, Inc.
P51-913-2435-03
In Commercial Distribution

  • 00889795145475 ()
P51-913-2435-03

  • Surgical drill guide, reusable
Ovr Dr Gd, Dbl End, 2.4/3.5mm, R3CON
Paragon 28, Inc.
P51-913-2435
In Commercial Distribution

  • 00889795145468 ()
P51-913-2435

  • Surgical drill guide, reusable
Drill Guide Sleeve, 2.7mm, R3CON
Paragon 28, Inc.
P51-913-2027-03
In Commercial Distribution

  • 00889795145451 ()
P51-913-2027-03

  • Surgical drill guide, reusable
Ovr Dr Gd, Dbl End, 2.0/2.7mm, R3CON
Paragon 28, Inc.
P51-913-2027
In Commercial Distribution

  • 00889795145444 ()
P51-913-2027

  • Surgical drill guide, reusable
TOTAL ANKLE IMPLANT, INSERT, SIZE 5, 20 MM THICK, 0 OFFSET, XL VIT E UHMWPE
Paragon 28, Inc.
P10-310-I520-S
In Commercial Distribution

  • 00889795143938 ()
P10-310-I520-S

  • Fixed-bearing total ankle prosthesis
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