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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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MINISCOPE KIT WITH ROLLO BANDS
AMERICAN ORTHODONTICS CORPORATION
855-920
Not in Commercial Distribution

  • 00190746076329 ()
855-920

  • Orthodontic appliance system, bonded
HTH KIT WITH ROLLO BANDS
AMERICAN ORTHODONTICS CORPORATION
855-720
Not in Commercial Distribution

  • 00190746075896 ()
855-720

  • Orthodontic appliance system, bonded
FIXED FUNCT EXPANSION SCREW RAPID (13MM EXPANSION)
AMERICAN ORTHODONTICS CORPORATION
855-342
Not in Commercial Distribution

  • 00190746075094 ()
855-342

  • Orthodontic appliance system, bonded
FIXED FUNCT EXPANSION SCREW RAPID (9MM EXPANSION)
AMERICAN ORTHODONTICS CORPORATION
855-340
Not in Commercial Distribution

  • 00190746075070 ()
855-340

  • Orthodontic appliance system, bonded
LIP BUMPER 045 100MM SIZE 5 W/CUSPID HOOKS
AMERICAN ORTHODONTICS CORPORATION
852-705B
Not in Commercial Distribution

  • 00190746073458 ()
852-705B

  • Orthodontic appliance system, bonded
TruEase Rapid Palatal Expander 12mm
ORTHO TECHNOLOGY, INC.
S30-1216
In Commercial Distribution

  • 00190730030733 ()


  • Orthodontic appliance system, bonded
TruEase Rapid Palatal Expander 10mm
ORTHO TECHNOLOGY, INC.
S30-1014
In Commercial Distribution

  • 00190730030726 ()


  • Orthodontic appliance system, bonded
TruEase Rapid Palatal Expander 8mm
ORTHO TECHNOLOGY, INC.
S30-0812
In Commercial Distribution

  • 00190730030719 ()


  • Orthodontic appliance system, bonded
Drills 01/02.35x44.5
Preat Corporation
9003706
In Commercial Distribution

  • 00842092133323 ()
9003706

  • Cannulated surgical drill bit, single-use, non-sterile
Calibrated Drill Cannulated 5.0mm
FUSION ORTHOPEDICS, LLC
CD-IL-1050
In Commercial Distribution

  • 00819034029570 ()
CD-IL-1050

  • Cannulated surgical drill bit, single-use, non-sterile
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