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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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HammerTube Implant, 3.50mm, 0° Cannulated
Paragon 28, Inc.
P40-001-0350-S
In Commercial Distribution

  • 00889795057655 ()
P40-001-0350-S

  • Phalangeal joint arthrodesis implant
HammerTube Implant, 2.75mm, 0° Cannulated
Paragon 28, Inc.
P40-001-0275-S
In Commercial Distribution

  • 00889795057648 ()
P40-001-0275-S

  • Phalangeal joint arthrodesis implant
Silverback, Ankle Fusion, Lower Implant Tray
Paragon 28, Inc.
P50-900-1003
In Commercial Distribution

  • 00889795057594 ()
P50-900-1003

  • Device sterilization/disinfection container, reusable
Grappler Interference Screw, Caddy Lid
Paragon 28, Inc.
P41-900-LID
In Commercial Distribution

  • 00889795057587 ()
P41-900-LID

  • Device sterilization/disinfection container, reusable
Grappler Interference Screw Instruments, Caddy
Paragon 28, Inc.
P41-900-BASE
In Commercial Distribution

  • 00889795057570 ()
P41-900-BASE

  • Device sterilization/disinfection container, reusable
Suture Passer w/ Braided Nitinol Loop, Grappler™
Paragon 28, Inc.
P41-960-0020
In Commercial Distribution

  • 00889795057563 ()
P41-960-0020

  • Suturing unit, single-use
Grappler Interference Depth Gauge, 25mm
Paragon 28, Inc.
P41-950-0025
In Commercial Distribution

  • 00889795057556 ()
P41-950-0025

  • Surgical depth gauge, reusable
Screw Driver Attachment 7.0/8.0mm, Solid , A/O, Trilobe, Grappler
Paragon 28, Inc.
P41-940-7080
In Commercial Distribution

  • 00889795057549 ()
P41-940-7080

  • Surgical screwdriver, reusable
Screw Driver Attachment 5.5/6.0mm, Solid , A/O, Trilobe, Grappler
Paragon 28, Inc.
P41-940-5560
In Commercial Distribution

  • 00889795057532 ()
P41-940-5560

  • Surgical screwdriver, reusable
Screw Driver Attachment 4.5/5.0mm, Solid , A/O, Trilobe, Grappler
Paragon 28, Inc.
P41-940-4550
In Commercial Distribution

  • 00889795057525 ()
P41-940-4550

  • Surgical screwdriver, reusable
Screw Driver Attachment 4.0mm, Solid, A/O, Trilobe, Grappler
Paragon 28, Inc.
P41-940-3040
In Commercial Distribution

  • 00889795057518 ()
P41-940-3040

  • Surgical screwdriver, reusable
Tissue Protector Insert 8.5, Grappler
Paragon 28, Inc.
P41-930-8500
In Commercial Distribution

  • 00889795057501 ()
P41-930-8500

  • Orthopaedic implantation sleeve, reusable
Tissue Protector Insert 8.0, Grappler
Paragon 28, Inc.
P41-930-8000
In Commercial Distribution

  • 00889795057495 ()
P41-930-8000

  • Orthopaedic implantation sleeve, reusable
Tissue Protector Insert 7.5, Grappler
Paragon 28, Inc.
P41-930-7500
In Commercial Distribution

  • 00889795057488 ()
P41-930-7500

  • Orthopaedic implantation sleeve, reusable
Tissue Protector Insert 7.0, Grappler
Paragon 28, Inc.
P41-930-7000
In Commercial Distribution

  • 00889795057471 ()
P41-930-7000

  • Orthopaedic implantation sleeve, reusable
Tissue Protector Insert 6.5, Grappler
Paragon 28, Inc.
P41-930-6500
In Commercial Distribution

  • 00889795057464 ()
P41-930-6500

  • Orthopaedic implantation sleeve, reusable
Tissue Protector Insert 6.0, Grappler
Paragon 28, Inc.
P41-930-6000
In Commercial Distribution

  • 00889795057457 ()
P41-930-6000

  • Orthopaedic implantation sleeve, reusable
Tissue Protector Insert 5.5, Grappler
Paragon 28, Inc.
P41-930-5500
In Commercial Distribution

  • 00889795057440 ()
P41-930-5500

  • Orthopaedic implantation sleeve, reusable
Tissue Protector Insert 5.0, Grappler
Paragon 28, Inc.
P41-930-5000
In Commercial Distribution

  • 00889795057433 ()
P41-930-5000

  • Orthopaedic implantation sleeve, reusable
Tissue Protector Insert 4.5, Grappler
Paragon 28, Inc.
P41-930-4500
In Commercial Distribution

  • 00889795057426 ()
P41-930-4500

  • Orthopaedic implantation sleeve, reusable
Tissue Protector Insert 4.0, Grappler
Paragon 28, Inc.
P41-930-4000
In Commercial Distribution

  • 00889795057419 ()
P41-930-4000

  • Orthopaedic implantation sleeve, reusable
Tissue Protector Handle, Grappler
Paragon 28, Inc.
P41-930-0001
In Commercial Distribution

  • 00889795057402 ()
P41-930-0001

  • Orthopaedic implantation sleeve, reusable
Tendon Sizer, Grappler
Paragon 28, Inc.
P41-920-0001
In Commercial Distribution

  • 00889795057396 ()
P41-920-0001

  • Surgical implant template, reusable
Drill, 8.5 X 130mm, Cannulated, 3/16" Sq. Connection w/ Depth Mark
Paragon 28, Inc.
P41-910-8513
In Commercial Distribution

  • 00889795057389 ()
P41-910-8513

  • Cannulated surgical drill bit, reusable
Drill, 8.0 X 130mm, Cannulated, 3/16" Sq. Connection w/ Depth Mark
Paragon 28, Inc.
P41-910-8013
In Commercial Distribution

  • 00889795057372 ()
P41-910-8013

  • Cannulated surgical drill bit, reusable
Drill, 7.5 X 130mm, Cannulated, 3/16" Sq. Connection w/ Depth Mark
Paragon 28, Inc.
P41-910-7513
In Commercial Distribution

  • 00889795057365 ()
P41-910-7513

  • Cannulated surgical drill bit, reusable
Drill, 7.0 X 130mm, Cannulated, 3/16" Sq. Connection w/ Depth Mark
Paragon 28, Inc.
P41-910-7013
In Commercial Distribution

  • 00889795057358 ()
P41-910-7013

  • Cannulated surgical drill bit, reusable
Drill, 6.5 X 130mm, Cannulated, 3/16" Sq. Connection w/ Depth Mark
Paragon 28, Inc.
P41-910-6513
In Commercial Distribution

  • 00889795057341 ()
P41-910-6513

  • Cannulated surgical drill bit, reusable
Drill, 6.0 X 130mm, Cannulated, 3/16" Sq. Connection w/ Depth Mark
Paragon 28, Inc.
P41-910-6013
In Commercial Distribution

  • 00889795057334 ()
P41-910-6013

  • Cannulated surgical drill bit, reusable
Drill, 5.5 X 130mm, Cannulated, 3/16" Sq. Connection w/ Depth Mark
Paragon 28, Inc.
P41-910-5513
In Commercial Distribution

  • 00889795057327 ()
P41-910-5513

  • Cannulated surgical drill bit, reusable
Drill, 5.0 X 130mm, Cannulated, 3/16" Sq. Connection w/ Depth Mark
Paragon 28, Inc.
P41-910-5013
In Commercial Distribution

  • 00889795057310 ()
P41-910-5013

  • Cannulated surgical drill bit, reusable
Drill, 4.5 X 130mm, Cannulated, 3/16" Sq. Connection w/ Depth Mark
Paragon 28, Inc.
P41-910-4513
In Commercial Distribution

  • 00889795057303 ()
P41-910-4513

  • Cannulated surgical drill bit, reusable
Drill, 4.0 X 130mm, Cannulated, 3/16" Sq. Connection w/ Depth Mark
Paragon 28, Inc.
P41-910-4013
In Commercial Distribution

  • 00889795057297 ()
P41-910-4013

  • Cannulated surgical drill bit, reusable
(Extra Long) TenoTac Female Implant ø4.5mm x 2.2mm x 12.5mm Long
Paragon 28, Inc.
P42-122-0125
In Commercial Distribution

  • 00889795057280 ()
P42-122-0125

  • Tendon/ligament bone anchor, non-bioabsorbable
TenoTac Male Implant ø8mm x 2.2mm x 10mm Long
Paragon 28, Inc.
P42-822-0100
In Commercial Distribution

  • 00889795057273 ()
P42-822-0100

  • Tendon/ligament bone anchor, non-bioabsorbable
TenoTac Single Use ø2.8mm Cannulated Drill, ø8.0mm Countersink, 25mm Long
Paragon 28, Inc.
P42-938-2825
In Commercial Distribution

  • 00889795057266 ()
P42-938-2825

  • Surgical countersink, reusable
TenoTac Single Use ø2.8mm Cannulated Drill, ø6.0mm Countersink, 20mm Long
Paragon 28, Inc.
P42-937-2820
In Commercial Distribution

  • 00889795057259 ()
P42-937-2820

  • Surgical countersink, reusable
TenoTac Single Use Female Implant Length Gauge 1st
Paragon 28, Inc.
P42-935-0002
In Commercial Distribution

  • 00889795057242 ()
P42-935-0002

  • Surgical depth gauge, reusable
TenoTac Single Use Female Implant Length Gauge 2nd, 3rd, 4th
Paragon 28, Inc.
P42-935-0001
In Commercial Distribution

  • 00889795057235 ()
P42-935-0001

  • Surgical depth gauge, reusable
TenoTac Single Use Female Implant Driver, T15
Paragon 28, Inc.
P42-932-T151
In Commercial Distribution

  • 00889795057228 ()
P42-932-T151

  • Tendon/ligament bone anchor, non-bioabsorbable
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