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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Axi+Line Plate 5.0 Degree - Left
Medartis Inc.
AXL-050L
In Commercial Distribution

  • 00817701020516 ()


  • Orthopaedic fixation plate, non-bioabsorbable
Axi+Line Instrument Kit - Right
Medartis Inc.
AXL-000R
In Commercial Distribution

  • 00817701020509 ()


  • Orthopaedic fixation plate, non-bioabsorbable
Axi+Line Instrument Kit - Left
Medartis Inc.
AXL-000L
In Commercial Distribution

  • 00817701020493 ()


  • Orthopaedic fixation plate, non-bioabsorbable
Axi+Line Instrument Kit
Medartis Inc.
AXL-INST
In Commercial Distribution

  • 00817701027065 ()


  • Orthopaedic surgical procedure kit, non-medicated, single-use
Re+Line Driver
Medartis Inc.
RS-DR
In Commercial Distribution

  • 00817701020844 ()


  • Surgical screwdriver, single-use
3.5 mm Locking Screw - 30 mm Length
Medartis Inc.
SCR-3530L
In Commercial Distribution

  • 00817701020806 ()


  • Orthopaedic bone screw (non-sliding)
3.5mm Locking Screw - 24mm
Medartis Inc.
SCR-3524L
In Commercial Distribution

  • 00817701020776 ()


  • Orthopaedic bone screw (non-sliding)
3.5mm Locking Screw - 20mm
Medartis Inc.
SCR-3520L
In Commercial Distribution

  • 00817701020752 ()


  • Orthopaedic bone screw (non-sliding)
3.5mm Locking Screw - 12mm
Medartis Inc.
SCR-3512L
In Commercial Distribution

  • 00817701020714 ()


  • Orthopaedic bone screw (non-sliding)
15mm X 6 Re+Line Kit
Medartis Inc.
RS-15610K
In Commercial Distribution

  • 00817701020080 ()


  • Internal orthopaedic fixation system, plate/screw, non-bioabsorbable, sterile
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