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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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
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
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
Folcrum 4.0 mm
FUSION ORTHOPEDICS, LLC
TN-LL-6504
In Commercial Distribution

  • 00840124506091 ()
TN-LL-6504

  • Cannulated surgical drill bit, single-use, non-sterile
Spacer 3.0mm
FUSION ORTHOPEDICS, LLC
TN-LL-6503
Not in Commercial Distribution

  • 00840124506084 ()
TN-LL-6503

  • Cannulated surgical drill bit, single-use, non-sterile
Spacer 2.0mm
FUSION ORTHOPEDICS, LLC
TN-LL-6502
Not in Commercial Distribution

  • 00840124506077 ()
TN-LL-6502

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