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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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Trial Handle, Cotton, 5mm
Paragon 28, Inc.
PCT-005
In Commercial Distribution

  • 00889795056917 ()
PCT-005

  • Surgical implant template, reusable
Trial Handle, Evans, 12mm
Paragon 28, Inc.
PET-0912
In Commercial Distribution

  • 00889795056900 ()
PET-0912

  • Surgical implant template, reusable
Trial Handle, Evans, 8mm
Paragon 28, Inc.
PET-0908
In Commercial Distribution

  • 00889795056894 ()
PET-0908

  • Surgical implant template, reusable
Trial Handle, Evans, 6mm
Paragon 28, Inc.
PET-0906
In Commercial Distribution

  • 00889795056887 ()
PET-0906

  • Surgical implant template, reusable
4.2MM X 18CM CANNULATED DRILL
Paragon 28, Inc.
P99-110-4218
In Commercial Distribution

  • 00889795056870 ()
P99-110-4218

  • Cannulated surgical drill bit, reusable
Foot Plate, Plantigrade Guide, Radiolucent, v 1.5
Paragon 28, Inc.
P99-900-1008
In Commercial Distribution

  • 00889795056856 ()
P99-900-1008

  • Orthopaedic prosthesis implantation positioning instrument, reusable
Drill, 4.6 x 300mm, Cannulated, 3/16" Sq. Connection
Paragon 28, Inc.
P99-110-4630
In Commercial Distribution

  • 00889795056849 ()
P99-110-4630

  • Cannulated surgical drill bit, single-use
Stepped Reamer
Paragon 28, Inc.
P99-110-0813
In Commercial Distribution

  • 00889795056832 ()
P99-110-0813

  • Bone-resection orthopaedic reamer, single-use
Screw Driver Attachment, Solid, 3/16" Sq. Connection, TX-20 x 90mm
Paragon 28, Inc.
P99-191-TX20-09
In Commercial Distribution

  • 00889795056795 ()
P99-191-TX20-09

  • Bone nail driver
Screw Driver Attachment, Solid, 3/16" Sq. Connection, TX-30 x 160mm
Paragon 28, Inc.
P99-191-TX30-16
In Commercial Distribution

  • 00889795056764 ()
P99-191-TX30-16

  • Bone nail driver
Drill, 4.6 X 300mm, Solid, Trocar Tip, 3/16" Sq. Connection
Paragon 28, Inc.
P99-100-4630
In Commercial Distribution

  • 00889795056757 ()
P99-100-4630

  • Fluted surgical drill bit, single-use
1.2 X 150 Mm K Wire, Single Ended Trocar Tip, Threaded
Paragon 28, Inc.
P99-193-1215
In Commercial Distribution

  • 00889795056719 ()
P99-193-1215

  • Orthopaedic bone wire
Compressor
Paragon 28, Inc.
P99-150-0089
In Commercial Distribution

  • 00889795056696 ()
P99-150-0089

  • Orthopaedic fixation implant alignment tool
Gorilla R3CON Drill Guide, 4.2mm
Paragon 28, Inc.
P51-901-0101
In Commercial Distribution

  • 00889795056337 ()
P51-901-0101

  • Surgical drill guide, reusable
BABY GORILLA Plate Caddy, Straight, L, T (Full Module)
Paragon 28, Inc.
P50-900-3006
In Commercial Distribution

  • 00889795056313 ()
P50-900-3006

  • Device sterilization/disinfection container, reusable
BABY GORILLA Plate Caddy, Oblique L, T, Y (Full Module)
Paragon 28, Inc.
P50-900-3007
In Commercial Distribution

  • 00889795056306 ()
P50-900-3007

  • Device sterilization/disinfection container, reusable
BABY GORILLA Instrument Caddy (Full Module)
Paragon 28, Inc.
P50-900-3005
In Commercial Distribution

  • 00889795056290 ()
P50-900-3005

  • Device sterilization/disinfection container, reusable
PROMO Screw Caddy Lid
Paragon 28, Inc.
P50-900-3108-1
In Commercial Distribution

  • 00889795056276 ()
P50-900-3108-1

  • Device sterilization/disinfection container, reusable
PROMO Case Base, Full Din
Paragon 28, Inc.
P50-900-3102
In Commercial Distribution

  • 00889795056252 ()
P50-900-3102

  • Device sterilization/disinfection container, reusable
SCREW CADDY ASSEMBLY W/O LID (6212-0003800-01)
Paragon 28, Inc.
P50-900-0009-1
In Commercial Distribution

  • 00889795056221 ()
P50-900-0009-1

  • Device sterilization/disinfection container, reusable
Silverback, Ankle Fusion, Screw Caddy, Lid
Paragon 28, Inc.
P50-900-1004-2
In Commercial Distribution

  • 00889795056207 ()
P50-900-1004-2

  • Device sterilization/disinfection container, reusable
Silverback, Ankle Fusion, Screw Caddy, Base
Paragon 28, Inc.
P50-900-1004-1
In Commercial Distribution

  • 00889795056191 ()
P50-900-1004-1

  • Device sterilization/disinfection container, reusable
Gorilla, Ankle Fracture, Posterior & Hook Plate Caddy
Paragon 28, Inc.
P50-900-AFHK-1
In Commercial Distribution

  • 00889795056108 ()
P50-900-AFHK-1

  • Device sterilization/disinfection container, reusable
PROMO Caddy Base
Paragon 28, Inc.
P50-900-3109-1
In Commercial Distribution

  • 00889795056085 ()
P50-900-3109-1

  • Device sterilization/disinfection container, reusable
Baby Gorilla, Plate Caddy, Zig-Zig/Span Implants
Paragon 28, Inc.
P50-900-3011-1
In Commercial Distribution

  • 00889795056047 ()
P50-900-3011-1

  • Device sterilization/disinfection container, reusable
Baby Gorilla, Plate Caddy Lid, Mini
Paragon 28, Inc.
P50-900-MNCL
In Commercial Distribution

  • 00889795056023 ()
P50-900-MNCL

  • Device sterilization/disinfection container, reusable
Baby Gorilla, Instrument Tray
Paragon 28, Inc.
P50-900-3003
In Commercial Distribution

  • 00889795055989 ()
P50-900-3003

  • Device sterilization/disinfection container, reusable
Baby Gorilla, Case Lid (Full DIN)
Paragon 28, Inc.
P50-900-3001
In Commercial Distribution

  • 00889795055965 ()
P50-900-3001

  • Device sterilization/disinfection container, reusable
Phantom Nail, Crossing Screw, Ø5.0mm x 58mm length, Headed
Paragon 28, Inc.
P32-450-058F
In Commercial Distribution

  • 00889795055880 ()
P32-450-058F

  • Orthopaedic bone screw, non-bioabsorbable, non-sterile
Phantom Nail, Crossing Screw, Ø5.0mm x 34mm length, Headed
Paragon 28, Inc.
P32-450-034F
In Commercial Distribution

  • 00889795055835 ()
P32-450-034F

  • Orthopaedic bone screw, non-bioabsorbable, non-sterile
Phantom Nail, Crossing Screw, Ø5.0mm x 28mm length, Headed
Paragon 28, Inc.
P32-450-028F
In Commercial Distribution

  • 00889795055804 ()
P32-450-028F

  • Orthopaedic bone screw, non-bioabsorbable, non-sterile
Phantom Nail, Crossing Screw, Ø5.0mm x 52mm length, Headed
Paragon 28, Inc.
P32-450-052F
In Commercial Distribution

  • 00889795055705 ()
P32-450-052F

  • Orthopaedic bone screw, non-bioabsorbable, non-sterile
Phantom Nail, Crossing Screw, Ø5.0mm x 50mm length, Headed
Paragon 28, Inc.
P32-450-050F
In Commercial Distribution

  • 00889795055699 ()
P32-450-050F

  • Orthopaedic bone screw, non-bioabsorbable, non-sterile
Phantom Nail, Crossing Screw, Ø5.0mm x 48mm length, Headed
Paragon 28, Inc.
P32-450-048F
In Commercial Distribution

  • 00889795055682 ()
P32-450-048F

  • Orthopaedic bone screw, non-bioabsorbable, non-sterile
Phantom Nail, Crossing Screw, Ø5.0mm x 46mm length, Headed
Paragon 28, Inc.
P32-450-046F
In Commercial Distribution

  • 00889795055675 ()
P32-450-046F

  • Orthopaedic bone screw, non-bioabsorbable, non-sterile
Phantom Nail, Crossing Screw, Ø5.0mm x 42mm length, Headed
Paragon 28, Inc.
P32-450-042F
In Commercial Distribution

  • 00889795055651 ()
P32-450-042F

  • Orthopaedic bone screw, non-bioabsorbable, non-sterile
Phantom Nail, Calcaneus Screw, Ø7.2mm x 115mm length, Headless
Paragon 28, Inc.
P31-772-115F
In Commercial Distribution

  • 00889795055637 ()
P31-772-115F

  • Orthopaedic bone screw, non-bioabsorbable, non-sterile
Phantom Nail, Calcaneus Screw, Ø7.2mm x 105mm length, Headless
Paragon 28, Inc.
P31-772-105F
In Commercial Distribution

  • 00889795055613 ()
P31-772-105F

  • Orthopaedic bone screw, non-bioabsorbable, non-sterile
Phantom Nail, Calcaneus Screw, Ø7.2mm x 95mm length, Headless
Paragon 28, Inc.
P31-772-095F
In Commercial Distribution

  • 00889795055590 ()
P31-772-095F

  • Orthopaedic bone screw, non-bioabsorbable, non-sterile
Phantom Nail, Calcaneus Screw, Ø7.2mm x 90mm length, Headless
Paragon 28, Inc.
P31-772-090F
In Commercial Distribution

  • 00889795055583 ()
P31-772-090F

  • Orthopaedic bone screw, non-bioabsorbable, non-sterile
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