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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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Short Stem Tibia, Instrument, Drill Bit Cap D9, Tall
Paragon 28, Inc.
P11-854-C09T
In Commercial Distribution

  • 00889795136824 ()
P11-854-C09T

  • Cannulated surgical drill bit, single-use
Special Instrument, Straight Nail Short Dual Calc Screw Guide Assembly
Paragon 28, Inc.
SP31-950-0007
In Commercial Distribution

  • 00889795151780 ()
SP31-950-0007

  • Surgical drill guide, reusable
Special Instrument, Straight Nail Short Calc Screw K-wire Guide
Paragon 28, Inc.
SP31-950-0006
In Commercial Distribution

  • 00889795151773 ()
SP31-950-0006

  • Surgical drill guide, reusable
Special Instrument, Straight Nail Short Calc Screw Drill Guide
Paragon 28, Inc.
SP31-950-0004
In Commercial Distribution

  • 00889795151766 ()
SP31-950-0004

  • Surgical drill guide, reusable
Special Instrument, Precision MIS Drill/K-wire Guide, 4.0 Screw
Paragon 28, Inc.
SP27-943-0040
In Commercial Distribution

  • 00889795150059 ()
SP27-943-0040

  • Surgical drill guide, reusable
Special Instrument, Precision MIS Drill/K-wire Guide, 3.5 Screw
Paragon 28, Inc.
SP27-943-0035
In Commercial Distribution

  • 00889795150042 ()
SP27-943-0035

  • Surgical drill guide, reusable
Special Instrument, Precision MIS Drill/K-wire Guide, 3.0 Screw
Paragon 28, Inc.
SP27-943-0030
In Commercial Distribution

  • 00889795150035 ()
SP27-943-0030

  • Surgical drill guide, reusable
Gorilla®, R3CON™ Screw, Ø2.7 x 74mm, Non-Locking, Solid, TiA
Paragon 28, Inc.
P50-453-2774
In Commercial Distribution

  • 00889795150011 ()
P50-453-2774

  • Orthopaedic bone screw (non-sliding)
Gorilla®, R3CON™ Screw, Ø2.7 x 72mm, Non-Locking, Solid, TiA
Paragon 28, Inc.
P50-453-2772
In Commercial Distribution

  • 00889795150004 ()
P50-453-2772

  • Orthopaedic bone screw (non-sliding)
MIS Chamfer Screw, 5mm Reduction Wire
Paragon 28, Inc.
SP27-182-0005
In Commercial Distribution

  • 00889795146625 ()
SP27-182-0005

  • Orthopaedic guidewire, single-use
3D Printed Lapidus Trial, 4mm, 0Deg
Paragon 28, Inc.
PLT-3DP-0004
In Commercial Distribution

  • 00889795146601 ()
PLT-3DP-0004

  • Surgical implant/trial-implant/sizer holder, reusable
3D Printed Evans Trial, 4mm
Paragon 28, Inc.
PET-3DP-0004
In Commercial Distribution

  • 00889795146595 ()
PET-3DP-0004

  • Surgical implant/trial-implant/sizer holder, reusable
3D Printed Cotton Trial, 10mm
Paragon 28, Inc.
PCT-3DP-0010
In Commercial Distribution

  • 00889795146588 ()
PCT-3DP-0010

  • Surgical implant/trial-implant/sizer holder, reusable
3D Printed Cotton Trial, 9mm
Paragon 28, Inc.
PCT-3DP-0009
In Commercial Distribution

  • 00889795146571 ()
PCT-3DP-0009

  • Surgical implant/trial-implant/sizer holder, reusable
Specialty Instrument, Metatarsal Pusher
Paragon 28, Inc.
SP27-102-1000
In Commercial Distribution

  • 00889795146564 ()
SP27-102-1000

  • Orthopaedic prosthesis implantation positioning instrument, reusable
PCFD Tether, System Tray, Lid
Paragon 28, Inc.
P62-CAD-0002
In Commercial Distribution

  • 00889795146502 ()
P62-CAD-0002

  • Device sterilization/disinfection container, reusable
1.6mm x 400mm, Entry Guidewire, Ball Tip
Paragon 28, Inc.
P36-912-1641
In Commercial Distribution

  • 00889795146496 ()
P36-912-1641

  • Orthopaedic guidewire, single-use
Phantom Fibula Nail System, Case 1 of 1, Cannulated Reamer Case Base
Paragon 28, Inc.
P36-900-FIB3
In Commercial Distribution

  • 00889795146304 ()
P36-900-FIB3

  • Device sterilization/disinfection container, reusable
1.6mm x 400mm, Sterilization K-Wire Container
Paragon 28, Inc.
P36-913-1640
In Commercial Distribution

  • 00889795146298 ()
P36-913-1640

  • Device sterilization/disinfection container, reusable
6.5mm Proximal Reamer, Cannulated, AO Quick Connect
Paragon 28, Inc.
P36-925-6531
In Commercial Distribution

  • 00889795146281 ()
P36-925-6531

  • Bone-resection orthopaedic reamer, single-use
6.0mm Proximal Reamer, Cannulated, AO Quick Connect
Paragon 28, Inc.
P36-925-6031
In Commercial Distribution

  • 00889795146274 ()
P36-925-6031

  • Bone-resection orthopaedic reamer, single-use
5.2mm Proximal Reamer, Cannulated, AO Quick Connect
Paragon 28, Inc.
P36-925-5231
In Commercial Distribution

  • 00889795146267 ()
P36-925-5231

  • Bone-resection orthopaedic reamer, single-use
4.5mm Proximal Reamer, Cannulated, AO Quick Connect
Paragon 28, Inc.
P36-925-4531
In Commercial Distribution

  • 00889795146250 ()
P36-925-4531

  • Bone-resection orthopaedic reamer, single-use
3.9mm Proximal Reamer, Cannulated, AO Quick Connect
Paragon 28, Inc.
P36-925-3931
In Commercial Distribution

  • 00889795146243 ()
P36-925-3931

  • Bone-resection orthopaedic reamer, single-use
3.3mm Proximal Reamer, Cannulated, AO Quick Connect
Paragon 28, Inc.
P36-925-3331
In Commercial Distribution

  • 00889795146236 ()
P36-925-3331

  • Bone-resection orthopaedic reamer, single-use
1.6mm x 400mm, Entry Guidewire, Trocar
Paragon 28, Inc.
P36-912-1640
In Commercial Distribution

  • 00889795146229 ()
P36-912-1640

  • Orthopaedic guidewire, single-use
Short Stem Tibia System, Instrument, Drill Caddy Lid
Paragon 28, Inc.
P11-900-0004
In Commercial Distribution

  • 00889795146182 ()
P11-900-0004

  • Device sterilization/disinfection container, reusable
PCFD Tether, Suture Retriever
Paragon 28, Inc.
P62-910-0010
In Commercial Distribution

  • 00889795146007 ()
P62-910-0010

  • Orthopaedic surgical procedure kit, non-medicated, 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
TOTAL ANKLE IMPLANT, INSERT, SIZE 5, 10 MM THICK, 0 OFFSET, XL VIT E UHMWPE
Paragon 28, Inc.
P10-310-I510-S
In Commercial Distribution

  • 00889795143877 ()
P10-310-I510-S

  • Fixed-bearing total ankle prosthesis
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