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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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Symmetry Aufricht-Glabella - 00887482121122

Symmetry® Rasp, Aufricht-Glabella, 8 mm x 28 mm Tip, 8 in, 203 mm
SYMMETRY SURGICAL INC.
67-5940
In Commercial Distribution

  • 00887482121122 ()

  • Width: 8 Millimeter
  • Depth: 28 Millimeter
  • Length: 8 Inch
67-5940

  • Bone file/rasp, manual, reusable

Trinity Biotech - 05391516747950

Bartels® Cytotoxicity Assay for Clostridium difficile Toxin Product B1029-70, Store Toxi-Titer Plate @ 35-37 °C, Store Reagents @ 2-8 °C, 48 Tests
MARDX DIAGNOSTICS, INC.
B1029-70
In Commercial Distribution

  • 05391516747950 ()
B1029-70

  • Clostridium difficile antigen IVD, kit, enzyme immunoassay (EIA)

AORTIC ROOT RETRACTOR - 00850200006568

AORTIC ROOT RETRACTOR, LARGE
LSI Solutions, Inc.
080280
In Commercial Distribution

  • 10850200006565 ()
  • 00850200006568 ()

  • Outer Diameter: 28 Millimeter
080280

  • Aortic root retraction system

Conformis Hip System - 00850268007644

TRIAL HEAD, UNIVERSAL, 28MM
Conformis, Inc.
1080-580
In Commercial Distribution

  • 00850268007644 ()

  • Outer Diameter: 28 Millimeter


  • Orthopaedic prosthesis implantation positioning instrument, reusable

Conformis Hip System - 00850268007590

TRIAL HEAD, 28MM +7
Conformis, Inc.
1080-565
In Commercial Distribution

  • 00850268007590 ()

  • Outer Diameter: 28 Millimeter


  • Orthopaedic prosthesis implantation positioning instrument, reusable

n/a - 00822409075348

28mm Femoral Head Impactor
Ortho Development Corporation
208-0328
In Commercial Distribution

  • 00822409075348 ()

  • Lumen/Inner Diameter: 28 Millimeter


  • Orthopaedic implant impactor, reusable

n/a - 00822409088706

Neutral Cup Pusher Head 28mm
Ortho Development Corporation
277-0028
In Commercial Distribution

  • 00822409088706 ()

  • Outer Diameter: 28 Millimeter


  • Orthopaedic implant/instrument assembling device

n/a - 00822409086085

28mm Liner Impactor, Metal
Ortho Development Corporation
270-5228
In Commercial Distribution

  • 00822409086085 ()

  • Outer Diameter: 28 Millimeter


  • Orthopaedic implant impactor, reusable

N/A - 00822409084173

12/14 Femoral Head Trial 28-6 Primaloc
Ortho Development Corporation
238-2860P
In Commercial Distribution

  • 00822409084173 ()

  • Outer Diameter: 28 Millimeter


  • Femoral head prosthesis trial

N/A - 00822409084159

12/14 Femoral Head Trial 28-3 Primaloc
Ortho Development Corporation
238-2830P
In Commercial Distribution

  • 00822409084159 ()

  • Outer Diameter: 28 Millimeter


  • Femoral head prosthesis trial
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