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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Navicula to 2nd Met, Long, Left, 2.0mm
Paragon 28, Inc.
P53-108-L102
In Commercial Distribution

  • 00889795118875 ()
P53-108-L102

  • Internal orthopaedic fixation system, plate/screw, non-bioabsorbable, non-sterile
Navicula to 2nd Met, Standard, Right, 2.0mm
Paragon 28, Inc.
P53-108-R101
In Commercial Distribution

  • 00889795118844 ()
P53-108-R101

  • Internal orthopaedic fixation system, plate/screw, non-bioabsorbable, non-sterile
Talus to 2nd Met, Long, Left, 1.5mm
Paragon 28, Inc.
P53-108-L012
In Commercial Distribution

  • 00889795118837 ()
P53-108-L012

  • Internal orthopaedic fixation system, plate/screw, non-bioabsorbable, non-sterile
Talus to 2nd Met, Long, Right, 1.5mm
Paragon 28, Inc.
P53-108-R012
In Commercial Distribution

  • 00889795118813 ()
P53-108-R012

  • Internal orthopaedic fixation system, plate/screw, non-bioabsorbable, non-sterile
Talus to 2nd Met, Standard, Right, 1.5mm
Paragon 28, Inc.
P53-108-R011
In Commercial Distribution

  • 00889795118806 ()
P53-108-R011

  • Internal orthopaedic fixation system, plate/screw, non-bioabsorbable, non-sterile
Navicula to 2nd Met, Long, Left, 1.5mm
Paragon 28, Inc.
P53-108-L002
In Commercial Distribution

  • 00889795118790 ()
P53-108-L002

  • Internal orthopaedic fixation system, plate/screw, non-bioabsorbable, non-sterile
Navicula to 2nd Met, Standard, Left, 1.5mm
Paragon 28, Inc.
P53-108-L001
In Commercial Distribution

  • 00889795118783 ()
P53-108-L001

  • Internal orthopaedic fixation system, plate/screw, non-bioabsorbable, non-sterile
Navicula to 2nd Met, Long, Right, 1.5mm
Paragon 28, Inc.
P53-108-R002
In Commercial Distribution

  • 00889795118776 ()
P53-108-R002

  • Internal orthopaedic fixation system, plate/screw, non-bioabsorbable, non-sterile
Navicula to 2nd Met, Standard, Right, 1.5mm
Paragon 28, Inc.
P53-108-R001
In Commercial Distribution

  • 00889795118769 ()
P53-108-R001

  • Internal orthopaedic fixation system, plate/screw, non-bioabsorbable, non-sterile
AO Cotton Wedge Instrument Caddy Lid
Paragon 28, Inc.
AOCWC-01-02
In Commercial Distribution

  • 00889795118738 ()
AOCWC-01-02

  • Device sterilization/disinfection container, reusable
AO Evans Wedge Instrument Caddy Lid
Paragon 28, Inc.
AOEWC-01-02
In Commercial Distribution

  • 00889795118721 ()
AOEWC-01-02

  • Device sterilization/disinfection container, reusable
AO Cotton Wedge Instrument Caddy Base
Paragon 28, Inc.
AOCWC-01-01
In Commercial Distribution

  • 00889795118714 ()
AOCWC-01-01

  • Device sterilization/disinfection container, reusable
AO Evans Wedge Instrument Caddy Base
Paragon 28, Inc.
AOEWC-01-01
In Commercial Distribution

  • 00889795118707 ()
AOEWC-01-01

  • Device sterilization/disinfection container, reusable
AO Evans Wedge Trial Spacer 22-12
Paragon 28, Inc.
AOEW-22-12 TRL
In Commercial Distribution

  • 00889795118691 ()
AOEW-22-12 TRL

  • Surgical implant/trial-implant/sizer holder, reusable
AO Evans Wedge Trial Spacer 22-10
Paragon 28, Inc.
AOEW-22-10 TRL
In Commercial Distribution

  • 00889795118684 ()
AOEW-22-10 TRL

  • Surgical implant/trial-implant/sizer holder, reusable
AO Evans Wedge Trial Spacer 22-8
Paragon 28, Inc.
AOEW-22-8 TRL
In Commercial Distribution

  • 00889795118677 ()
AOEW-22-8 TRL

  • Surgical implant/trial-implant/sizer holder, reusable
AO Evans Wedge Trial Spacer 20-12
Paragon 28, Inc.
AOEW-20-12 TRL
In Commercial Distribution

  • 00889795118660 ()
AOEW-20-12 TRL

  • Surgical implant/trial-implant/sizer holder, reusable
AO Evans Wedge Trial Spacer 20-10
Paragon 28, Inc.
AOEW-20-10 TRL
In Commercial Distribution

  • 00889795118653 ()
AOEW-20-10 TRL

  • Surgical implant/trial-implant/sizer holder, reusable
AO Evans Wedge Trial Spacer 20-8
Paragon 28, Inc.
AOEW-20-8 TRL
In Commercial Distribution

  • 00889795118646 ()
AOEW-20-8 TRL

  • Surgical implant/trial-implant/sizer holder, reusable
AO Evans Wedge Trial Spacer 18-12
Paragon 28, Inc.
AOEW-18-12 TRL
In Commercial Distribution

  • 00889795118639 ()
AOEW-18-12 TRL

  • Surgical implant/trial-implant/sizer holder, reusable
AO Evans Wedge Trial Spacer 18-10
Paragon 28, Inc.
AOEW-18-10 TRL
In Commercial Distribution

  • 00889795118622 ()
AOEW-18-10 TRL

  • Surgical implant/trial-implant/sizer holder, reusable
Phantom ActivCore Nail, 11.5 X 300mm Sterile Packaged
Paragon 28, Inc.
P31-215-3000-S
In Commercial Distribution

  • 00889795118103 ()
P31-215-3000-S

  • Arthrodesis intramedullary nail, non-distracting
Phantom ActivCore Nail, 11.5 X 250mm Sterile Packaged
Paragon 28, Inc.
P31-215-2500-S
In Commercial Distribution

  • 00889795118097 ()
P31-215-2500-S

  • Arthrodesis intramedullary nail, non-distracting
Phantom ActivCore Nail, 11.5 X 200mm Sterile Packaged
Paragon 28, Inc.
P31-215-2000-S
In Commercial Distribution

  • 00889795118080 ()
P31-215-2000-S

  • Arthrodesis intramedullary nail, non-distracting
Phantom ActivCore Nail, 10.0 X 300mm Sterile Packaged
Paragon 28, Inc.
P31-202-3000-S
In Commercial Distribution

  • 00889795118073 ()
P31-202-3000-S

  • Arthrodesis intramedullary nail, non-distracting
Phantom ActivCore Nail, 10.0 X 250mm Sterile Packaged
Paragon 28, Inc.
P31-202-2500-S
In Commercial Distribution

  • 00889795118066 ()
P31-202-2500-S

  • Arthrodesis intramedullary nail, non-distracting
Phantom ActivCore Nail, 10.0 X 200mm Sterile Packaged
Paragon 28, Inc.
P31-202-2000-S
In Commercial Distribution

  • 00889795118059 ()
P31-202-2000-S

  • Arthrodesis intramedullary nail, non-distracting
Ghost 2.0 Proximal Extension
Paragon 28, Inc.
P31-950-2035
In Commercial Distribution

  • 00889795118042 ()
P31-950-2035

  • Orthopaedic fixation implant alignment tool
Ghost 2.0 Targeting Device
Paragon 28, Inc.
P31-950-2000
In Commercial Distribution

  • 00889795118035 ()
P31-950-2000

  • Orthopaedic fixation implant alignment tool
Anti Microbial pads
Paragon 28, Inc.
P45-600-1000-S
In Commercial Distribution

  • 00889795118004 ()
P45-600-1000-S

  • Absorbent underpad, antimicrobial
Ø6.0mm Half Pin Quick Connect (SP1306)
Paragon 28, Inc.
P45-965-6000-S
In Commercial Distribution

  • 00889795117991 ()
P45-965-6000-S

  • External orthopaedic fixation system, single-use
Ø5.0mm Half Pin Quick Connect (SP1305)
Paragon 28, Inc.
P45-965-5000-S
In Commercial Distribution

  • 00889795117984 ()
P45-965-5000-S

  • External orthopaedic fixation system, single-use
Ø4.0mm Half Pin Quick Connect (SF1304)
Paragon 28, Inc.
P45-965-4000-S
In Commercial Distribution

  • 00889795117977 ()
P45-965-4000-S

  • External orthopaedic fixation system, single-use
Ø3.2mm x 195mm Drill for HA Half Pins (SF1324)
Paragon 28, Inc.
P45-960-3219-S
In Commercial Distribution

  • 00889795117960 ()
P45-960-3219-S

  • Cannulated surgical drill bit, single-use
Half Pin, Self Drilling, Ø6.0mm X 50mm, 180mm SHANK LENGTH, HA COATED (ST156180HA)
Paragon 28, Inc.
P45-199-6045-S
In Commercial Distribution

  • 00889795117953 ()
P45-199-6045-S

  • External orthopaedic fixation system, single-use
Half Pin, Self Drilling, Ø5.0mm X 50mm, 180mm SHANK LENGTH, HA COATED (ST145180HA)
Paragon 28, Inc.
P45-199-5045-S
In Commercial Distribution

  • 00889795117946 ()
P45-199-5045-S

  • External orthopaedic fixation system, single-use
Half Pin, Self Drilling, Ø4.0mm x 34mm, 120mm SHANK LENGTH, HA COATED (ST134120HA)
Paragon 28, Inc.
P45-199-4035-S
In Commercial Distribution

  • 00889795117939 ()
P45-199-4035-S

  • External orthopaedic fixation system, single-use
Wire Cutter
Paragon 28, Inc.
P99-150-0121
In Commercial Distribution

  • 00889795117922 ()
P99-150-0121

  • Orthopaedic implantable-device cutter
Tang Angled Socket Wrench, 10mm
Paragon 28, Inc.
P45-513-0003
In Commercial Distribution

  • 00889795117915 ()
P45-513-0003

  • Surgical torque wrench, reusable
Speed Nut
Paragon 28, Inc.
P45-941-0002
In Commercial Distribution

  • 00889795117908 ()
P45-941-0002

  • External orthopaedic fixation system, single-use
APEX 3D™ Cross-linked Vitamin E POLY, SIZE 5 x 10MM, 4MM POST OFFSET
Paragon 28, Inc.
P10-31P-I510-S
In Commercial Distribution

  • 00889795117892 ()
P10-31P-I510-S

  • Fixed-bearing total ankle prosthesis
APEX 3D™ Cross-linked Vitamin E POLY, SIZE 5 x 9MM, 4MM POST OFFSET
Paragon 28, Inc.
P10-31P-I509-S
In Commercial Distribution

  • 00889795117885 ()
P10-31P-I509-S

  • Fixed-bearing total ankle prosthesis
APEX 3D™ Cross-linked Vitamin E POLY, SIZE 5 x 8MM, 4MM POST OFFSET
Paragon 28, Inc.
P10-31P-I508-S
In Commercial Distribution

  • 00889795117878 ()
P10-31P-I508-S

  • Fixed-bearing total ankle prosthesis
APEX 3D™ Cross-linked Vitamin E POLY, SIZE 5 x 7MM, 4MM POST OFFSET
Paragon 28, Inc.
P10-31P-I507-S
In Commercial Distribution

  • 00889795117861 ()
P10-31P-I507-S

  • Fixed-bearing total ankle prosthesis
APEX 3D™ Cross-linked Vitamin E POLY, SIZE 5 x 6MM, 4MM POST OFFSET
Paragon 28, Inc.
P10-31P-I506-S
In Commercial Distribution

  • 00889795117854 ()
P10-31P-I506-S

  • Fixed-bearing total ankle prosthesis
APEX 3D™ Cross-linked Vitamin E POLY, SIZE 4 x 10MM, 3.75MM POST OFFSET
Paragon 28, Inc.
P10-31P-I410-S
In Commercial Distribution

  • 00889795117847 ()
P10-31P-I410-S

  • Fixed-bearing total ankle prosthesis
APEX 3D™ Cross-linked Vitamin E POLY, SIZE 4 x 9MM, 3.75MM POST OFFSET
Paragon 28, Inc.
P10-31P-I409-S
In Commercial Distribution

  • 00889795117830 ()
P10-31P-I409-S

  • Fixed-bearing total ankle prosthesis
APEX 3D™ Cross-linked Vitamin E POLY, SIZE 4 x 8MM, 3.75MM POST OFFSET
Paragon 28, Inc.
P10-31P-I408-S
In Commercial Distribution

  • 00889795117823 ()
P10-31P-I408-S

  • Fixed-bearing total ankle prosthesis
APEX 3D™ Cross-linked Vitamin E POLY, SIZE 4 x 7MM, 3.75MM POST OFFSET
Paragon 28, Inc.
P10-31P-I407-S
In Commercial Distribution

  • 00889795117816 ()
P10-31P-I407-S

  • Fixed-bearing total ankle prosthesis
APEX 3D™ Cross-linked Vitamin E POLY, SIZE 4 x 6MM, 3.75MM POST OFFSET
Paragon 28, Inc.
P10-31P-I406-S
In Commercial Distribution

  • 00889795117809 ()
P10-31P-I406-S

  • Fixed-bearing total ankle prosthesis
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