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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14 x 7 Subtalar Trial
Paragon 28, Inc.
PST-1407
In Commercial Distribution

  • 00889795057129 ()
PST-1407

  • Surgical implant template, reusable
16 x 8 Subtalar Trial
Paragon 28, Inc.
PST-1608
In Commercial Distribution

  • 00889795057112 ()
PST-1608

  • Surgical implant template, reusable
10 x 5 Subtalar Trial
Paragon 28, Inc.
PST-1005
In Commercial Distribution

  • 00889795057105 ()
PST-1005

  • Surgical implant template, reusable
16mm Calc-Cuboid Trial Assembly
Paragon 28, Inc.
PCC-016
In Commercial Distribution

  • 00889795057099 ()
PCC-016

  • Surgical implant template, reusable
14mm Calc-Cuboid Trial Assembly
Paragon 28, Inc.
PCC-014
In Commercial Distribution

  • 00889795057082 ()
PCC-014

  • Surgical implant template, reusable
8mm Calc-Cuboid Trial Assembly
Paragon 28, Inc.
PCC-008
In Commercial Distribution

  • 00889795057075 ()
PCC-008

  • Surgical implant template, reusable
Subtalar Handle
Paragon 28, Inc.
PST-0001
In Commercial Distribution

  • 00889795057068 ()
PST-0001

  • Surgical implant template, reusable
Subtalar Coin Correction Guide
Paragon 28, Inc.
PST-0002
In Commercial Distribution

  • 00889795057051 ()
PST-0002

  • Surgical implant template, reusable
12mm Calc-Cuboid Trial Assembly
Paragon 28, Inc.
PCC-010
In Commercial Distribution

  • 00889795057044 ()
PCC-010

  • Surgical implant template, reusable
19 MM X 20 MM MTP DISC TRIAL HANDLE
Paragon 28, Inc.
PMT-1920
In Commercial Distribution

  • 00889795057037 ()
PMT-1920

  • Surgical implant template, reusable
19 MM X 15 MM MTP DISC TRIAL HANDLE
Paragon 28, Inc.
PMT-1915
In Commercial Distribution

  • 00889795057020 ()
PMT-1915

  • Surgical implant template, reusable
10 MM X 21 MM MTP DISC TRIAL HANDLE
Paragon 28, Inc.
PMT-2110
In Commercial Distribution

  • 00889795057013 ()
PMT-2110

  • Surgical implant template, reusable
5 MM X 21 MM MTP DISC TRIAL HANDLE
Paragon 28, Inc.
PMT-2105
In Commercial Distribution

  • 00889795057006 ()
PMT-2105

  • Surgical implant template, reusable
10 MM X 18 MM MTP DISC TRIAL HANDLE
Paragon 28, Inc.
PMT-1910
In Commercial Distribution

  • 00889795056993 ()
PMT-1910

  • Surgical implant template, reusable
8 MM X 19 MM MTP DISC TRIAL HANDLE
Paragon 28, Inc.
PMT-1908
In Commercial Distribution

  • 00889795056986 ()
PMT-1908

  • Surgical implant template, reusable
5 MM X 19MM MTP DISC TRIAL HANDLE
Paragon 28, Inc.
PMT-1905
In Commercial Distribution

  • 00889795056979 ()
PMT-1905

  • Surgical implant template, reusable
12 MM LAPIDUS, 12 DEGREE, TRIAL HANDLE
Paragon 28, Inc.
PLT-1212
In Commercial Distribution

  • 00889795056962 ()
PLT-1212

  • Surgical implant template, reusable
Trial Handle, Lapidus, 8mm
Paragon 28, Inc.
PLT-0808
In Commercial Distribution

  • 00889795056955 ()
PLT-0808

  • Surgical implant template, reusable
5 MM LAPIDUS, 5 DEGREE, TRIAL HANDLE
Paragon 28, Inc.
PLT-0505
In Commercial Distribution

  • 00889795056948 ()
PLT-0505

  • Surgical implant template, reusable
Trial Handle, Cotton, 8mm
Paragon 28, Inc.
PCT-008
In Commercial Distribution

  • 00889795056931 ()
PCT-008

  • Surgical implant template, reusable
Trial Handle, Cotton, 7mm
Paragon 28, Inc.
PCT-007
In Commercial Distribution

  • 00889795056924 ()
PCT-007

  • Surgical implant template, reusable
Trial Handle, Cotton, 5mm
Paragon 28, Inc.
PCT-005
In Commercial Distribution

  • 00889795056917 ()
PCT-005

  • Surgical implant template, reusable
Trial Handle, Evans, 12mm
Paragon 28, Inc.
PET-0912
In Commercial Distribution

  • 00889795056900 ()
PET-0912

  • Surgical implant template, reusable
Trial Handle, Evans, 8mm
Paragon 28, Inc.
PET-0908
In Commercial Distribution

  • 00889795056894 ()
PET-0908

  • Surgical implant template, reusable
Trial Handle, Evans, 6mm
Paragon 28, Inc.
PET-0906
In Commercial Distribution

  • 00889795056887 ()
PET-0906

  • Surgical implant template, reusable
4.2MM X 18CM CANNULATED DRILL
Paragon 28, Inc.
P99-110-4218
In Commercial Distribution

  • 00889795056870 ()
P99-110-4218

  • Cannulated surgical drill bit, reusable
Foot Plate, Plantigrade Guide, Radiolucent, v 1.5
Paragon 28, Inc.
P99-900-1008
In Commercial Distribution

  • 00889795056856 ()
P99-900-1008

  • Orthopaedic prosthesis implantation positioning instrument, reusable
Drill, 4.6 x 300mm, Cannulated, 3/16" Sq. Connection
Paragon 28, Inc.
P99-110-4630
In Commercial Distribution

  • 00889795056849 ()
P99-110-4630

  • Cannulated surgical drill bit, single-use
Stepped Reamer
Paragon 28, Inc.
P99-110-0813
In Commercial Distribution

  • 00889795056832 ()
P99-110-0813

  • Bone-resection orthopaedic reamer, single-use
Screw Driver Attachment, Solid, 3/16" Sq. Connection, TX-20 x 90mm
Paragon 28, Inc.
P99-191-TX20-09
In Commercial Distribution

  • 00889795056795 ()
P99-191-TX20-09

  • Bone nail driver
Screw Driver Attachment, Solid, 3/16" Sq. Connection, TX-30 x 160mm
Paragon 28, Inc.
P99-191-TX30-16
In Commercial Distribution

  • 00889795056764 ()
P99-191-TX30-16

  • Bone nail driver
Drill, 4.6 X 300mm, Solid, Trocar Tip, 3/16" Sq. Connection
Paragon 28, Inc.
P99-100-4630
In Commercial Distribution

  • 00889795056757 ()
P99-100-4630

  • Fluted surgical drill bit, single-use
Slap Hammer
Paragon 28, Inc.
P99-150-2002
In Commercial Distribution

  • 00889795056740 ()
P99-150-2002

  • Surgical screwdriver, reusable
ThorHammer
Paragon 28, Inc.
P99-150-2001
In Commercial Distribution

  • 00889795056733 ()
P99-150-2001

  • Surgical mallet
1.2 X 150 Mm K Wire, Single Ended Trocar Tip, Threaded
Paragon 28, Inc.
P99-193-1215
In Commercial Distribution

  • 00889795056719 ()
P99-193-1215

  • Orthopaedic bone wire
Shannon-Style Bone Burr, 3.0mm
Paragon 28, Inc.
P99-105-3080-S
In Commercial Distribution

  • 00889795056702 ()
P99-105-3080-S

  • Orthopaedic bur, single-use
Compressor
Paragon 28, Inc.
P99-150-0089
In Commercial Distribution

  • 00889795056696 ()
P99-150-0089

  • Orthopaedic fixation implant alignment tool
Bone Graft Harvester Caddy
Paragon 28, Inc.
P99-900-HARV
In Commercial Distribution

  • 00889795056689 ()
P99-900-HARV

  • Device sterilization/disinfection container, reusable
K-Wire, Single Ended Trocar Tip, Threaded, 2.5 x 150mm
Paragon 28, Inc.
P99-193-2515
In Commercial Distribution

  • 00889795056672 ()
P99-193-2515

  • Orthopaedic bone wire
Caspar Type Compression/Distraction Device
Paragon 28, Inc.
P99-150-0011-R
In Commercial Distribution

  • 00889795056665 ()
P99-150-0011-R

  • Osteotomy compression/distraction instrument
Lobster Claw, Closed
Paragon 28, Inc.
P99-150-T017
In Commercial Distribution

  • 00889795056641 ()
P99-150-T017

  • Bone holding forceps
R3LEASE Device, 3.9 X 48mm, 17mm Notch
Paragon 28, Inc.
P80-239-1748
In Commercial Distribution

  • 00889795056634 ()
P80-239-1748

  • Orthopaedic bone screw, non-bioabsorbable, non-sterile
R3LEASE Device, 3.9 X 48mm, 14mm Notch
Paragon 28, Inc.
P80-239-1448
In Commercial Distribution

  • 00889795056627 ()
P80-239-1448

  • Orthopaedic bone screw, non-bioabsorbable, non-sterile
Anterior Plates, Ball Tip Wire Guide
Paragon 28, Inc.
P51-980-5005
In Commercial Distribution

  • 00889795056450 ()
P51-980-5005

  • Orthopaedic prosthesis implantation positioning instrument, reusable
Gorilla R3con Drill Guide, Off Axis
Paragon 28, Inc.
P51-901-3102
In Commercial Distribution

  • 00889795056443 ()
P51-901-3102

  • Surgical drill guide, reusable
Gorilla R3con Drill Guide, Easy Guide, 2.7/3.5
Paragon 28, Inc.
P51-901-3101
In Commercial Distribution

  • 00889795056436 ()
P51-901-3101

  • Surgical drill guide, reusable
Gorilla R3con Drill Guide, 4.2 MM
Paragon 28, Inc.
P51-901-3142
In Commercial Distribution

  • 00889795056429 ()
P51-901-3142

  • Surgical drill guide, reusable
Clover Plate: 5-Hole w/ Compression, Left
Paragon 28, Inc.
P53-110-L301
In Commercial Distribution

  • 00889795010049 ()

  • Clover Plate: 5-Hole w/ Compression, Left
P53-110-L301

  • Internal orthopaedic fixation system, plate/screw, non-bioabsorbable, non-sterile
Lapidus, Medial Wall-Step-Off, 5 mm Step Plate, Right (1.4mm thick)
Paragon 28, Inc.
P53-106-R205
In Commercial Distribution

  • 00889795009906 ()

  • Lapidus, Medial Wall-Step-Off, 5 mm Step Plate, Right (1.4mm thick)
P53-106-R205

  • Internal orthopaedic fixation system, plate/screw, non-bioabsorbable, non-sterile
Precision Guide Lapidus, Medial Wall-Step-Off, 3 mm Step Plate, Right (1.4mm thick)
Paragon 28, Inc.
P53-106-R203
In Commercial Distribution

  • 00889795009883 ()

  • Precision Guide Lapidus, Medial Wall-Step-Off, 3 mm Step Plate, Right (1.4mm thick)
P53-106-R203

  • Internal orthopaedic fixation system, plate/screw, non-bioabsorbable, non-sterile
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