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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T8 TORX SCREWDRIVER
Orthopediatrics Canada ULC
GIN-TRX800
In Commercial Distribution

  • 07540194011749 ()
GIN-TRX800

  • Surgical screwdriver, reusable
T6 TORX SCREWDRIVER
Orthopediatrics Canada ULC
GIN-TRX600
In Commercial Distribution

  • 07540194011732 ()
GIN-TRX600

  • Surgical screwdriver, reusable
A-O HANDLE - BULLET
Orthopediatrics Canada ULC
BLT-AOH100
In Commercial Distribution

  • 07540194011725 ()
BLT-AOH100

  • Surgical instrument handle, torque-limiting
BULLET RETENTION SLEEVE
Orthopediatrics Canada ULC
BLT-RSH100
In Commercial Distribution

  • 07540194011718 ()
BLT-RSH100

  • Surgical drill guide, reusable
BULLET GUIDEWIRE SLEEVE
Orthopediatrics Canada ULC
BLT-GWS100
In Commercial Distribution

  • 07540194011701 ()
BLT-GWS100

  • Orthopaedic prosthesis implantation positioning instrument, reusable
BULLET GUIDEWIRE Ø2.0mm x 305mm
Orthopediatrics Canada ULC
BLT-GWR200
In Commercial Distribution

  • 07540194011695 ()

  • Outer Diameter: 2 Millimeter
BLT-GWR200

  • Orthopaedic guidewire, single-use
BULLET GUIDEWIRE Ø1.1mm x 305mm
Orthopediatrics Canada ULC
BLT-GWR100
In Commercial Distribution

  • 07540194011688 ()

  • Outer Diameter: 1.1 Millimeter
BLT-GWR100

  • Orthopaedic guidewire, single-use
T-HANDLE
Orthopediatrics Canada ULC
BLT-AXH100
In Commercial Distribution

  • 07540194011671 ()
BLT-AXH100

  • Surgical instrument handle, non-torque-limiting
BULLET DRILL 6.0mm
Orthopediatrics Canada ULC
BLT-BDR160
In Commercial Distribution

  • 07540194011664 ()

  • Length: 175 Millimeter
  • Outer Diameter: 6.1 Millimeter
BLT-BDR160

  • Cannulated surgical drill bit, reusable
PEG Ø2.4mm x 60mm
Orthopediatrics Canada ULC
FD-PEG-24-060
In Commercial Distribution

  • 07540194017888 ()

  • Outer Diameter: 2.4 Millimeter
  • Length: 60 Millimeter
FD-PEG-24-060

  • Orthopaedic bone screw (non-sliding)
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