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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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Tatum Surgical-Osteotome Kit - 00083208002229

Tatum Universal Offset Osteotome Kit designed for use in bone expansion: Includes 24 instruments and 2 Autoclaveable cassettes: Bone Scalpels (Blue) - BS4.0, 5.0 & 6.0, Bone Blades (Green) - BB5.5, 7.5, & 10.0, "D" Shape (Black) - D1-4.0, D2-5.5, D3-7.5, & D4-10.0, Round Tapered (White) - RT2.0, 3.0, 4.0, & 5.0 Round Parallel Pointed (Yellow) - RP3.0, 3.5, 4.0, 4.5, & 5.0, Round Parallel Blunt (Red) - RB3.0, 3.5, 4.0, 4.5, & 5.0
Suncoast Dental, Inc
Tatum Universal Offset Osteotome Kit
In Commercial Distribution

  • 00083208002229 ()
Osteotomez Offset 24

  • Dental osteotome set

Tatum Surgical-Osteotome Kit - 00083208001116

Tatum Universal Straight Osteotome Kit designed for use in bone expansion: Includes 24 instruments and 2 Autoclaveable cassettes: Bone Scalpels (Blue) - BS4.0, 5.0 & 6.0, Bone Blades (Green) - BB5.5, 7.5, & 10.0, "D" Shape (Black) - D1-4.0, D2-5.5, D3-7.5, & D4-10.0, Round Tapered (White) - RT2.0, 3.0, 4.0, & 5.0 Round Parallel Pointed (Yellow) - RP3.0, 3.5, 4.0, 4.5, & 5.0, Round Parallel Blunt (Red) - RB3.0, 3.5, 4.0, 4.5, & 5.0
Suncoast Dental, Inc
Tatum Universal Straight Osteotome Kit
In Commercial Distribution

  • 00083208001116 ()
Osteotomez Str 24

  • Dental osteotome set

PERLA ® - 07640178975309

Sagittal bender left
SpineArt SA
CPF-IN 24 0L-N
In Commercial Distribution

  • 07640178975309 ()
CPF-IN 24 0L-N

  • Manual orthopaedic bender, reusable

PERLA ® - 07640178975293

Sagittal bender right
SpineArt SA
CPF-IN 24 0R-N
In Commercial Distribution

  • 07640178975293 ()
CPF-IN 24 0R-N

  • Manual orthopaedic bender, reusable

SCARLET AL-T INSTRUMENTATION - 07640185343344

Cup curette, angled DOWN, size “4”
SpineArt SA
SCA-IN 24 01-N
In Commercial Distribution

  • 07640185343344 ()
SCA-IN 24 01-N

  • Bone curette, reusable

SCARLET AL-T INSTRUMENTATION - 07640185343337

Cup curette, straight, size “4”
SpineArt SA
SCA-IN 24 00-N
In Commercial Distribution

  • 07640185343337 ()
SCA-IN 24 00-N

  • Bone curette, reusable

ROMEO 2 INSTRUMENTATION - 07640178981829

ROD TRIAL LONG
SpineArt SA
ELL-IN 24 02-N
In Commercial Distribution

  • 07640178981829 ()
ELL-IN 24 02-N

  • Spinal implant trial

ROMEO 2 INSTRUMENTATION - 07640178981812

ROD TRIAL SHORT
SpineArt SA
ELL-IN 24 01-N
In Commercial Distribution

  • 07640178981812 ()
ELL-IN 24 01-N

  • Spinal implant trial

ROMEO 2 INSTRUMENTATION - 07640178981805

REAMER
SpineArt SA
ELL-IN 24 00-N
In Commercial Distribution

  • 07640178981805 ()
ELL-IN 24 00-N

  • Bone file/rasp, manual, reusable

PERLA ® TL MIS - 07640450863249

CALIPER - ARM 2
SpineArt SA
MPF-IN 24 01-N
In Commercial Distribution

  • 07640450863249 ()
MPF-IN 24 01-N

  • Surgical depth gauge, reusable
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