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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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Drill Guide, EZ Cone Ø3.5mm, Long
Paragon 28, Inc.
P51-901-5035
In Commercial Distribution

  • 00889795111180 ()
P51-901-5035

  • Surgical drill guide, reusable
Drill Guide, EZ Cone Ø2.7mm, Long
Paragon 28, Inc.
P51-901-5027
In Commercial Distribution

  • 00889795111173 ()
P51-901-5027

  • Surgical drill guide, reusable
Kocher Clamp, Straight, 1x2 Teeth, 160mm
Paragon 28, Inc.
P99-150-KC01
In Commercial Distribution

  • 00889795111166 ()
P99-150-KC01

  • Bone approximation clamp
APEX 3D-PS Total Ankle Replacement System, Talar PSI Resection Block, Size 5
Paragon 28, Inc.
P10-944-PSI5
In Commercial Distribution

  • 00889795111159 ()
P10-944-PSI5

  • Osteotomy guide, reusable
Gorilla, R3con, Drill Guide Compression Slot, 4.2 Long
Paragon 28, Inc.
P51-903-3006
In Commercial Distribution

  • 00889795111142 ()
P51-903-3006

  • Surgical drill guide, reusable
Gorilla, R3con, Drill Guide Compression Slot, 3.5 Long
Paragon 28, Inc.
P51-903-3005
In Commercial Distribution

  • 00889795111135 ()
P51-903-3005

  • Surgical drill guide, reusable
APEX 3D-PS Total Ankle Replacement System, Talar PSI Resection Block, Size 1 Narrow
Paragon 28, Inc.
P10-944-PSI0
In Commercial Distribution

  • 00889795111111 ()
P10-944-PSI0

  • Osteotomy guide, reusable
Total Ankle, Revision Poly Caddy
Paragon 28, Inc.
P10-900-RVNP
In Commercial Distribution

  • 00889795111104 ()
P10-900-RVNP

  • Device sterilization/disinfection container, reusable
Gorilla, R3con, Drill Guide Compression Slot, 2.7 Long
Paragon 28, Inc.
P51-903-3004
In Commercial Distribution

  • 00889795111098 ()
P51-903-3004

  • Surgical drill guide, reusable
Laser Alignment Guide
Paragon 28, Inc.
P10-941-LAZM
In Commercial Distribution

  • 00889795111067 ()
P10-941-LAZM

  • Orthopaedic fixation implant alignment tool
Saw Blade 9 x 31 x .051mm Stryker (Sterile)
Paragon 28, Inc.
P99-151-P30S-1-S
In Commercial Distribution

  • 00889795111029 ()
P99-151-P30S-1-S

  • Surgical saw blade, oscillating, single-use
Saw Blade 9 x 31 x .051mm, MicroAire (Sterile)
Paragon 28, Inc.
P99-151-P30M-1-S
In Commercial Distribution

  • 00889795111012 ()
P99-151-P30M-1-S

  • Surgical saw blade, oscillating, single-use
MgNum, Bone Void Filler, Mixing and Delivery System
Paragon 28, Inc.
P02-BVF-AUX1
In Commercial Distribution

  • 00889795111005 ()
P02-BVF-AUX1

  • Bone graft delivery kit
MgNum, Bone Void Filler, 15cc
Paragon 28, Inc.
P02-BVF-0015
In Commercial Distribution

  • 00889795110992 ()
P02-BVF-0015

  • Bone matrix implant, synthetic, non-antimicrobial
MgNum, Bone Void Filler, 10cc
Paragon 28, Inc.
P02-BVF-0010
In Commercial Distribution

  • 00889795110985 ()
P02-BVF-0010

  • Bone matrix implant, synthetic, non-antimicrobial
MgNum, Bone Void Filler, 5cc
Paragon 28, Inc.
P02-BVF-0005
In Commercial Distribution

  • 00889795110978 ()
P02-BVF-0005

  • Bone matrix implant, synthetic, non-antimicrobial
HEX SCREW DRIVER, SHORT, 3.5mm X 155mm
Paragon 28, Inc.
P99-150-HX35-SHORT
In Commercial Distribution

  • 00889795110961 ()
P99-150-HX35-SHORT

  • Surgical screwdriver, reusable
Screw Retention Sleeve
Paragon 28, Inc.
P99-191-SL10
In Commercial Distribution

  • 00889795110954 ()
P99-191-SL10

  • Orthopaedic implantation sleeve, reusable
Gorilla, Ankle Fx, Threaded Positioning Tower, LONG
Paragon 28, Inc.
P51-900-2002
In Commercial Distribution

  • 00889795110947 ()
P51-900-2002

  • Surgical drill guide, reusable
Ø3.5 x 13cm Solid Over Drill
Paragon 28, Inc.
P99-100-3513
In Commercial Distribution

  • 00889795110930 ()
P99-100-3513

  • Cannulated surgical drill bit, reusable
Ø2.0 x 14cm Solid Drill
Paragon 28, Inc.
P99-100-2013
In Commercial Distribution

  • 00889795110923 ()
P99-100-2013

  • Cannulated surgical drill bit, reusable
Ø4.2 Gorilla Tap
Paragon 28, Inc.
P51-911-4200
In Commercial Distribution

  • 00889795110916 ()
P51-911-4200

  • Bone tap, reusable
Ø3.5 Gorilla Tap
Paragon 28, Inc.
P51-911-3500
In Commercial Distribution

  • 00889795110909 ()
P51-911-3500

  • Bone tap, reusable
Posterior TT Plate, Standard, Flat, Left, 06-Hole, TiA
Paragon 28, Inc.
P53-403-L201
In Commercial Distribution

  • 00889795110305 ()
P53-403-L201

  • Orthopaedic fixation plate, non-bioabsorbable, non-sterile
Silverback Gorilla Anterior TT Plate Template, Standard, Right
Paragon 28, Inc.
P54-401-R101
In Commercial Distribution

  • 00889795110183 ()
P54-401-R101

  • Internal orthopaedic fixation system, plate/screw, non-bioabsorbable, non-sterile
Paratrooper Caddy Base
Paragon 28, Inc.
P13-900-BASE
In Commercial Distribution

  • 00889795107602 ()
P13-900-BASE

  • Device sterilization/disinfection container, reusable
PALM Ratcheting Driver Handle w/ AO Connect w/ Suture Cleat
Paragon 28, Inc.
P99-000-AORP
In Commercial Distribution

  • 00889795107589 ()
P99-000-AORP

  • Surgical instrument handle, non-torque-limiting
Blind-Tunnel Suture Loop Guide Rod w/ Nitinol Loop
Paragon 28, Inc.
P41-960-0030
In Commercial Distribution

  • 00889795107565 ()
P41-960-0030

  • Suturing unit, single-use
Ø4.5/5.0 Driver Sleeve
Paragon 28, Inc.
P41-942-4550
In Commercial Distribution

  • 00889795107534 ()
P41-942-4550

  • Orthopaedic implantation sleeve, reusable
Ø7.0/8.0 Driver, Cannulated
Paragon 28, Inc.
P41-941-7080
In Commercial Distribution

  • 00889795107527 ()
P41-941-7080

  • Fluted surgical drill bit, single-use
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