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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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3.5 x 22 mm R3CON Locking Plate Screw
Paragon 28, Inc.
P50-353-3522
In Commercial Distribution

  • 00889795016515 ()

  • 3.5 x 22 mm R3CON Locking Plate Screw
  • Outer Diameter: 3.5 Millimeter
P50-353-3522

  • Orthopaedic bone screw, non-bioabsorbable, non-sterile
3.5 x 20 mm R3CON Locking Plate Screw
Paragon 28, Inc.
P50-353-3520
In Commercial Distribution

  • 00889795016508 ()

  • 3.5 x 20 mm R3CON Locking Plate Screw
  • Outer Diameter: 3.5 Millimeter
P50-353-3520

  • Orthopaedic bone screw, non-bioabsorbable, non-sterile
3.5 x 18 mm R3CON Locking Plate Screw
Paragon 28, Inc.
P50-353-3518
In Commercial Distribution

  • 00889795016492 ()

  • Outer Diameter: 3.5 Millimeter
  • 3.5 x 18 mm R3CON Locking Plate Screw
P50-353-3518

  • Orthopaedic bone screw, non-bioabsorbable, non-sterile
3.5 x 16 mm R3CON Locking Plate Screw
Paragon 28, Inc.
P50-353-3516
In Commercial Distribution

  • 00889795016485 ()

  • 3.5 x 16 mm R3CON Locking Plate Screw
  • Outer Diameter: 3.5 Millimeter
P50-353-3516

  • Orthopaedic bone screw, non-bioabsorbable, non-sterile
3.5 x 14 mm R3CON Locking Plate Screw
Paragon 28, Inc.
P50-353-3514
In Commercial Distribution

  • 00889795016478 ()

  • Outer Diameter: 3.5 Millimeter
  • 3.5 x 14 mm R3CON Locking Plate Screw
P50-353-3514

  • Orthopaedic bone screw, non-bioabsorbable, non-sterile
3.5 x 12 mm R3CON Locking Plate Screw
Paragon 28, Inc.
P50-353-3512
In Commercial Distribution

  • 00889795016461 ()

  • 3.5 x 12 mm R3CON Locking Plate Screw
  • Outer Diameter: 3.5 Millimeter
P50-353-3512

  • Orthopaedic bone screw, non-bioabsorbable, non-sterile
3.5 x 10 mm R3CON Locking Plate Screw
Paragon 28, Inc.
P50-353-3510
In Commercial Distribution

  • 00889795016454 ()

  • 3.5 x 10 mm R3CON Locking Plate Screw
  • Outer Diameter: 3.5 Millimeter
P50-353-3510

  • Orthopaedic bone screw, non-bioabsorbable, non-sterile
APEX 3D™ Tibia, Arc, Right, Size 1, Short, 3DP
Paragon 28, Inc.
P10-100-BR10-S
In Commercial Distribution

  • 00889795059727 ()
P10-100-BR10-S

  • Fixed-bearing total ankle prosthesis
APEX 3D™ Tibia, Arc, Left, Size 6, Long, 3DP
Paragon 28, Inc.
P10-100-BL6L-S
In Commercial Distribution

  • 00889795059710 ()
P10-100-BL6L-S

  • Fixed-bearing total ankle prosthesis
APEX 3D™ Tibia, Arc, Left, Size 5, Standard, 3DP
Paragon 28, Inc.
P10-100-BL5S-S
In Commercial Distribution

  • 00889795059703 ()
P10-100-BL5S-S

  • Fixed-bearing total ankle prosthesis
APEX 3D™ Tibia, Arc, Left, Size 5, Long, 3DP
Paragon 28, Inc.
P10-100-BL5L-S
In Commercial Distribution

  • 00889795059697 ()
P10-100-BL5L-S

  • Fixed-bearing total ankle prosthesis
APEX 3D™ Tibia, Arc, Left, Size 4, Standard, 3DP
Paragon 28, Inc.
P10-100-BL4S-S
In Commercial Distribution

  • 00889795059680 ()
P10-100-BL4S-S

  • Fixed-bearing total ankle prosthesis
APEX 3D™ Tibia, Arc, Left, Size 4, Long, 3DP
Paragon 28, Inc.
P10-100-BL4L-S
In Commercial Distribution

  • 00889795059673 ()
P10-100-BL4L-S

  • Fixed-bearing total ankle prosthesis
APEX 3D™ Tibia, Arc, Left, Size 3, Long, 3DP
Paragon 28, Inc.
P10-100-BL3L-S
In Commercial Distribution

  • 00889795059659 ()
P10-100-BL3L-S

  • Fixed-bearing total ankle prosthesis
APEX 3D™ Tibia, Arc, Left, Size 2, Standard, 3DP
Paragon 28, Inc.
P10-100-BL2S-S
In Commercial Distribution

  • 00889795059642 ()
P10-100-BL2S-S

  • Fixed-bearing total ankle prosthesis
APEX 3D™ Tibia, Arc, Left, Size 2, Long, 3DP
Paragon 28, Inc.
P10-100-BL2L-S
In Commercial Distribution

  • 00889795059635 ()
P10-100-BL2L-S

  • Fixed-bearing total ankle prosthesis
APEX 3D™ Tibia, Arc, Left, Size 1, Standard, 3DP
Paragon 28, Inc.
P10-100-BL1S-S
In Commercial Distribution

  • 00889795059628 ()
P10-100-BL1S-S

  • Fixed-bearing total ankle prosthesis
APEX 3D™ Tibia, Arc, Left, Size 1, Long, 3DP
Paragon 28, Inc.
P10-100-BL1L-S
In Commercial Distribution

  • 00889795059611 ()
P10-100-BL1L-S

  • Fixed-bearing total ankle prosthesis
APEX 3D™ Tibia, Arc, Left, Size 1, Short, 3DP
Paragon 28, Inc.
P10-100-BL10-S
In Commercial Distribution

  • 00889795059604 ()
P10-100-BL10-S

  • Fixed-bearing total ankle prosthesis
HammerTube™ System Implant Kit, Ø3.50 x 16mm, 10°, Sterile
Paragon 28, Inc.
P40-002-0350-SK
In Commercial Distribution

  • 00889795057723 ()
P40-002-0350-SK

  • Phalangeal joint arthrodesis implant
HammerTube™ System Implant Kit, Ø3.50 x 16mm, 0°, Sterile
Paragon 28, Inc.
P40-001-0350-SK
In Commercial Distribution

  • 00889795057716 ()
P40-001-0350-SK

  • Phalangeal joint arthrodesis implant
HammerTube™ System Implant Kit, Ø2.75 x 14mm, 10°, Sterile
Paragon 28, Inc.
P40-002-0275-SK
In Commercial Distribution

  • 00889795057709 ()
P40-002-0275-SK

  • Phalangeal joint arthrodesis implant
HammerTube™ System Implant Kit, Ø2.75 x 14mm, 0°, Sterile
Paragon 28, Inc.
P40-001-0275-SK
In Commercial Distribution

  • 00889795057693 ()
P40-001-0275-SK

  • Phalangeal joint arthrodesis implant
HammerToe Implant X-ray Overlay (HammerGraft & Hammertube)
Paragon 28, Inc.
P40-XRY-TPLT
In Commercial Distribution

  • 00889795057686 ()
P40-XRY-TPLT

  • Surgical implant template, reusable
HammerTube Implant, 3.50mm, 10° Cannulated
Paragon 28, Inc.
P40-002-0350-S
In Commercial Distribution

  • 00889795057679 ()
P40-002-0350-S

  • Phalangeal joint arthrodesis implant
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
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 Instruments, Caddy
Paragon 28, Inc.
P41-900-BASE
In Commercial Distribution

  • 00889795057570 ()
P41-900-BASE

  • Device sterilization/disinfection container, reusable
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 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
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