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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INSTRUMENT & IMPLANT CASE - FULL
Orthopediatrics Canada ULC
Y3P-CSF-150
In Commercial Distribution

  • 07540194006516 ()
Y3P-CSF-150

  • General internal orthopaedic fixation system implantation kit
COMBINED SCFE CASE, 3rd Gen.
Orthopediatrics Canada ULC
SCF-CSF550
In Commercial Distribution

  • 07540194006011 ()
SCF-CSF550

  • General internal orthopaedic fixation system implantation kit
Hinge Plate Kit (Instrument & Implants)
Orthopediatrics Canada ULC
HPK300
In Commercial Distribution

  • 07540194005946 ()
HPK300

  • General internal orthopaedic fixation system implantation kit
FULL SCFE IMPLANT & INSTRUMENT CASE 2nd Gen.
Orthopediatrics Canada ULC
SCF-CSF400
In Commercial Distribution

  • 07540194004451 ()
SCF-CSF400

  • General internal orthopaedic fixation system implantation kit
FULL MINI SCFE IMPLANT CASE
Orthopediatrics Canada ULC
SCF-CCF230
In Commercial Distribution

  • 07540194004376 ()
SCF-CCF230

  • General internal orthopaedic fixation system implantation kit
FULL SCFE IMPLANT & INSTRUMENT CASE
Orthopediatrics Canada ULC
SCF-CSF200
In Commercial Distribution

  • 07540194004369 ()
SCF-CSF200

  • General internal orthopaedic fixation system implantation kit
BULLET DRILL 4.8mm
Orthopediatrics Canada ULC
BLT-BDR148
In Commercial Distribution

  • 07540194011657 ()

  • Outer Diameter: 5.1 Millimeter
BLT-BDR148

  • Cannulated surgical drill bit, reusable
BULLET DRIVER
Orthopediatrics Canada ULC
BLT-BLD100
In Commercial Distribution

  • 07540194011640 ()
BLT-BLD100

  • Surgical screwdriver, reusable
BULLET KEY
Orthopediatrics Canada ULC
BLT-BKY100
In Commercial Distribution

  • 07540194011633 ()
BLT-BKY100

  • Surgical screwdriver, reusable
SCFE HANDLE-SHAFT SUBASSY Ø7.3mm - MINI
Orthopediatrics Canada ULC
SCF-DHS273
In Commercial Distribution

  • 07540194010988 ()
SCF-DHS273

  • Orthopaedic inorganic implant inserter/extractor, reusable
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