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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Olive Wire Threaded
FUSION ORTHOPEDICS, LLC
CD-LL-0040
In Commercial Distribution

  • 00840124506039 ()
CD-LL-0040

  • Cannulated surgical drill bit, single-use, non-sterile
Orthopaedic bone screw, non-bioabsorbable, sterile
FLOWER ORTHOPEDICS CORPORATION
FSS 200
In Commercial Distribution

  • 00840118117937 ()


  • Orthopaedic bone screw, non-bioabsorbable, sterile
SEWON MEDIX IH Screw Driver Ratchet-type Int. Hex, Ø4.0x15.0mm
sewon medix Inc.
RIHD20L
In Commercial Distribution

  • 08800041358816 ()
RIHD20L

  • Dental implant/prosthesis surgical procedure kit
SEWON MEDIX IH Screw Driver Machine-type Int. Hex, Ø4.0x13.5mm
sewon medix Inc.
MIHD20L
In Commercial Distribution

  • 08800041358786 ()
MIHD20L

  • Dental implant/prosthesis surgical procedure kit
DYONICS POWER PIN DRIVER
Smith & Nephew, Inc.
7205790
In Commercial Distribution

  • 03596010410726 ()
7205790

  • Surgical power tool system handpiece, wire-driving, rechargeable battery-powered
DYONICS POWER WIRE DRIVER
Smith & Nephew, Inc.
7205789
In Commercial Distribution

  • 03596010409003 ()
7205789

  • Surgical power tool system handpiece, wire-driving, rechargeable battery-powered
Bone Fixation Self-Drilling Screw kit with various size of bone screw for securing bone blocks Tatum EZ-Fixation Bone Screw Kit. Includes: Cassette, Driver handle, Driver Tip, Latch grip driver tip, (5) 8mm, (5) 10mm, (5) 12mm, and (3) 14mm Screws, 1.0 and 1.8 Drill.
Suncoast Dental, Inc
E-Z bone Fixation Screw Kit
In Commercial Distribution

  • 00083208000003 ()
EZ-Bone Fixation Screw Kit

  • Craniofacial bone screw, non-bioabsorbable, non-sterile
Driver Torx Lag 3.0mm
FUSION ORTHOPEDICS, LLC
CD-IL-3040
In Commercial Distribution

  • 00840124502291 ()
CD-IL-3040

  • Orthopaedic bone screw, non-bioabsorbable, non-sterile
Driver Torx Solid Set Screw 2.0mm
FUSION ORTHOPEDICS, LLC
CD-IL-3520
In Commercial Distribution

  • 00840124502277 ()
CD-IL-3520

  • Orthopaedic bone screw, non-bioabsorbable, non-sterile
Fenestration Drill 2.0 mm
FUSION ORTHOPEDICS, LLC
CD-LL-1020
In Commercial Distribution

  • 00840124501720 ()
CD-LL-1020

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