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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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LapiLock - 00840124506343

Spacer Lock
FUSION ORTHOPEDICS, LLC
TN-LL-6900
Not in Commercial Distribution

  • 00840124506343 ()
TN-LL-6900

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

LapiLock - 00840124506336

Spacer Lock Long
FUSION ORTHOPEDICS, LLC
TN-LL-6901
Not in Commercial Distribution

  • 00840124506336 ()
TN-LL-6901

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

PolyLock - 00840124506282

Bunion Plate Distall Drill 2.7mm SB
FUSION ORTHOPEDICS, LLC
CD-SB-1921
In Commercial Distribution

  • 00840124506282 ()
CD-SB-1921

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

PolyLock - 00840124506275

Bunion Plate Distal Drill 2.4mm
FUSION ORTHOPEDICS, LLC
CD-SB-1918
In Commercial Distribution

  • 00840124506275 ()
CD-SB-1918

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

PolyLock - 00840124506268

Bunion Plate Lag Drill SB
FUSION ORTHOPEDICS, LLC
CD-SB-1919
In Commercial Distribution

  • 00840124506268 ()
CD-SB-1919

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

TruEase - 00190730030726

TruEase Rapid Palatal Expander 10mm
ORTHO TECHNOLOGY, INC.
S30-1014
In Commercial Distribution

  • 00190730030726 ()


  • Orthodontic appliance system, bonded

TruEase - 00190730030719

TruEase Rapid Palatal Expander 8mm
ORTHO TECHNOLOGY, INC.
S30-0812
In Commercial Distribution

  • 00190730030719 ()


  • Orthodontic appliance system, bonded

TruEase - 00190730030733

TruEase Rapid Palatal Expander 12mm
ORTHO TECHNOLOGY, INC.
S30-1216
In Commercial Distribution

  • 00190730030733 ()


  • Orthodontic appliance system, bonded

Masel - 00190707041311

LBB™ Lombardi Bionator Bite Appliance
ORTHO ORGANIZERS, INC.
5200-100
Not in Commercial Distribution

  • 00190707041311 ()


  • Orthodontic appliance system, bonded

Carriere® MOTION 3D™ - 00190707086633

Carriere® MOTION 3D™ Hands-On Training Supplies - SILVER, no instrument - For Training Purposes Only
ORTHO ORGANIZERS, INC.
633-424SNI
In Commercial Distribution

  • 00190707086633 ()


  • Orthodontic appliance system, bonded
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