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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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Fentanyl Qualitative Calibrator Set - 00850624008278

FEN Cutoff Calibrator 5 ng/mL (1 x 5 mL).
LIN-ZHI INTERNATIONAL, INC.
09330097190
In Commercial Distribution

  • 00850624008278 ()
09330097190

  • Fentanyl IVD, calibrator

Ring-Handled Channel Brush - 00843356100020

Ring-Handled Channel Brush 1.67mm (5 French) 6"Length - 5 Brushes
CYGNUS MEDICAL L.L.C.
90-005
In Commercial Distribution

  • 30843356100021 ()
  • 00843356100020 ()


  • Surgical instrument/endoscope cleaning utensil, single-use

Ramvac - D060RV520

AERAS 5 DRY VACUUM ONLY 5 USER, 230VAC, 1 PHASE
Dentalez Alabama, Inc.
RV52
In Commercial Distribution

  • D060RV520 ()


  • Dental suction system pump

CERTAIN® PREVAIL® - 00844868005988

CERTAIN® PREVAIL® IMPLANT 5/6/5 X 8.5MM
BIOMET 3I, LLC
IIOS5685
Not in Commercial Distribution

  • 00844868005988 ()

  • Diameter 5 mm
  • Collar Diameter 6 mm
  • Restorative Platform Diameter 5 mm
  • Length: 8.5 Millimeter


  • Screw endosteal dental implant, two-piece

CERTAIN® PREVAIL® - 00844868005971

CERTAIN® PREVAIL® IMPLANT 5/6/5 X 15MM
BIOMET 3I, LLC
IIOS5615
Not in Commercial Distribution

  • 00844868005971 ()

  • Restorative Platform Diameter 5 mm
  • Length: 15 Millimeter
  • Collar Diameter 6 mm
  • Diameter 5 mm


  • Screw endosteal dental implant, two-piece

CERTAIN® PREVAIL® - 00844868005964

CERTAIN® PREVAIL® IMPLANT 5/6/5 X 13MM
BIOMET 3I, LLC
IIOS5613
Not in Commercial Distribution

  • 00844868005964 ()

  • Diameter 5 mm
  • Restorative Platform Diameter 5 mm
  • Collar Diameter 6 mm
  • Length: 13 Millimeter


  • Screw endosteal dental implant, two-piece

CERTAIN® PREVAIL® - 00844868005957

CERTAIN® PREVAIL® IMPLANT 5/6/5 X 11.5MM
BIOMET 3I, LLC
IIOS5611
Not in Commercial Distribution

  • 00844868005957 ()

  • Restorative Platform Diameter 5 mm
  • Length: 11.5 Millimeter
  • Collar Diameter 6 mm
  • Diameter 5 mm


  • Screw endosteal dental implant, two-piece

CERTAIN® PREVAIL® - 00844868005940

CERTAIN® PREVAIL® IMPLANT 5/6/5 X 10MM
BIOMET 3I, LLC
IIOS5610
Not in Commercial Distribution

  • 00844868005940 ()

  • Diameter 5 mm
  • Collar Diameter 6 mm
  • Length: 10 Millimeter
  • Restorative Platform Diameter 5 mm


  • Screw endosteal dental implant, two-piece

GC CROWNTEK™ - D6584121301

GC CROWNTEK™ Refill Size, 5 crowns of Premolar 5
Gc America Inc.
412130
Not in Commercial Distribution

  • D6584121301 ()
  • D6584121300 ()
412130

  • Preformed dental crown, temporary

Safco DENTA-SAFE DENTAL DAM - 10810063750210

Heavy (0.23mm-0.28mm thickness) 5" x 5", green, box of 52
SAFCO DENTAL SUPPLY CO.
1020759
In Commercial Distribution

  • 00810063750213 ()
  • 10810063750210 ()
1020759

  • Rubber dam, Hevea-latex
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