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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, 3.8 X 250mm Drill, Solid, Trocar Tip, 3/16" Sq. Connection
Paragon 28, Inc.
P99-100-3825
In Commercial Distribution

  • 00889795098108 ()
P99-100-3825

  • Fluted surgical drill bit, single-use
Explant Attachment, Phantom Hindfoot
Paragon 28, Inc.
P31-958-0001
In Commercial Distribution

  • 00889795098092 ()
P31-958-0001

  • Orthopaedic inorganic implant inserter/extractor, single-use
Bolt Driver Attachment, 8mm Hex, Phantom Hindfoot
Paragon 28, Inc.
P31-950-9000
In Commercial Distribution

  • 00889795098085 ()
P31-950-9000

  • Bone nail driver
Ghost Outrigger Homerun Guidewire Sleeve, 7.0mm
Paragon 28, Inc.
P31-950-1001-23
In Commercial Distribution

  • 00889795098078 ()
P31-950-1001-23

  • Orthopaedic implantation sleeve, reusable
Ghost Outrigger Subtalar Screw Guide, 7.2mm
Paragon 28, Inc.
P31-950-0009
In Commercial Distribution

  • 00889795098016 ()
P31-950-0009

  • Orthopaedic implantation sleeve, reusable
Phantom Hindfoot Ball Tipped Guide Rod, 3.0 x 550mm
Paragon 28, Inc.
P31-955-1550
In Commercial Distribution

  • 00889795097972 ()
P31-955-1550

  • Orthopaedic guidewire, single-use
Phantom Hindfoot TTC/TC Nail, Case Lid
Paragon 28, Inc.
P31-901-LID
In Commercial Distribution

  • 00889795097934 ()
P31-901-LID

  • Device sterilization/disinfection container, reusable
PRECISION® Parallel Offset Guide
Paragon 28, Inc.
P31-951-1000
In Commercial Distribution

  • 00889795097903 ()
P31-951-1000

  • Surgical drill guide, reusable
Wire Tube, 2.3 x 300mm
Paragon 28, Inc.
P31-941-0320
In Commercial Distribution

  • 00889795097828 ()
P31-941-0320

  • Device sterilization/disinfection container, reusable
Phantom ActivCore Nail, 13.0 X 250mm
Paragon 28, Inc.
P31-130-2500-S
In Commercial Distribution

  • 00889795097804 ()
P31-130-2500-S

  • Arthrodesis intramedullary nail, non-distracting
Phantom ActivCore Nail, 11.5 X 300mm
Paragon 28, Inc.
P31-115-3000-S
In Commercial Distribution

  • 00889795097774 ()
P31-115-3000-S

  • Arthrodesis intramedullary nail, non-distracting
Phantom ActivCore Nail, 11.5 X 250mm
Paragon 28, Inc.
P31-115-2500-S
In Commercial Distribution

  • 00889795097767 ()
P31-115-2500-S

  • Arthrodesis intramedullary nail, non-distracting
Phantom ActivCore Nail, 10.0 X 300mm
Paragon 28, Inc.
P31-102-3000-S
In Commercial Distribution

  • 00889795097736 ()
P31-102-3000-S

  • Arthrodesis intramedullary nail, non-distracting
Phantom ActivCore Nail, 10.0 X 250mm
Paragon 28, Inc.
P31-102-2500-S
In Commercial Distribution

  • 00889795097729 ()
P31-102-2500-S

  • Arthrodesis intramedullary nail, non-distracting
Phantom ActivCore Nail, 10.0 X 200mm
Paragon 28, Inc.
P31-102-2000-S
In Commercial Distribution

  • 00889795097712 ()
P31-102-2000-S

  • Arthrodesis intramedullary nail, non-distracting
Phantom ActivCore Nail, 10.0 X 175mm
Paragon 28, Inc.
P31-102-1750-S
In Commercial Distribution

  • 00889795097705 ()
P31-102-1750-S

  • Arthrodesis intramedullary nail, non-distracting
Phantom TC Nail, 13.0 X 250mm
Paragon 28, Inc.
P31-430-2500-S
In Commercial Distribution

  • 00889795097699 ()
P31-430-2500-S

  • Arthrodesis intramedullary nail, non-distracting
Phantom TC Nail, 13.0 X 200mm
Paragon 28, Inc.
P31-430-2000-S
In Commercial Distribution

  • 00889795097682 ()
P31-430-2000-S

  • Arthrodesis intramedullary nail, non-distracting
Phantom TC Nail, 13.0 X 175mm
Paragon 28, Inc.
P31-430-1750-S
In Commercial Distribution

  • 00889795097675 ()
P31-430-1750-S

  • Arthrodesis intramedullary nail, non-distracting
Phantom TC Nail, 13.0 X 150mm
Paragon 28, Inc.
P31-430-1500-S
In Commercial Distribution

  • 00889795097668 ()
P31-430-1500-S

  • Arthrodesis intramedullary nail, non-distracting
Phantom TC Nail, 11.5 X 300mm
Paragon 28, Inc.
P31-415-3000-S
In Commercial Distribution

  • 00889795097651 ()
P31-415-3000-S

  • Arthrodesis intramedullary nail, non-distracting
Phantom TC Nail, 11.5 X 250mm
Paragon 28, Inc.
P31-415-2500-S
In Commercial Distribution

  • 00889795097644 ()
P31-415-2500-S

  • Arthrodesis intramedullary nail, non-distracting
Phantom TC Nail, 11.5 X 200mm
Paragon 28, Inc.
P31-415-2000-S
In Commercial Distribution

  • 00889795097637 ()
P31-415-2000-S

  • Arthrodesis intramedullary nail, non-distracting
Phantom TC Nail, 11.5 X 150mm
Paragon 28, Inc.
P31-415-1500-S
In Commercial Distribution

  • 00889795097620 ()
P31-415-1500-S

  • Arthrodesis intramedullary nail, non-distracting
Phantom TC Nail, 10.0 X 300mm
Paragon 28, Inc.
P31-400-3000-S
In Commercial Distribution

  • 00889795097613 ()
P31-400-3000-S

  • Arthrodesis intramedullary nail, non-distracting
Phantom TC Nail, 10.0 X 250mm
Paragon 28, Inc.
P31-400-2500-S
In Commercial Distribution

  • 00889795097606 ()
P31-400-2500-S

  • Arthrodesis intramedullary nail, non-distracting
AVITRAC™ Core, MTP Reamer, Ø13 mm, STERILE
Paragon 28, Inc.
P01-901-1301-S
In Commercial Distribution

  • 00889795097576 ()
P01-901-1301-S

  • Bone-resection orthopaedic reamer, single-use
General Instrument, Lamina Spreader
Paragon 28, Inc.
P99-150-0030
In Commercial Distribution

  • 00889795097545 ()
P99-150-0030

  • Hand-held surgical retractor, reusable
APEX 3D™ Tibia, Flat, Right, Size 6, Standard, 3DP
Paragon 28, Inc.
P10-101-BR6S-S
In Commercial Distribution

  • 00889795097538 ()
P10-101-BR6S-S

  • Fixed-bearing total ankle prosthesis
APEX 3D™ Tibia, Arc, Left, Size 6, Standard, 3DP
Paragon 28, Inc.
P10-100-BL6S-S
In Commercial Distribution

  • 00889795097507 ()
P10-100-BL6S-S

  • Fixed-bearing total ankle prosthesis
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