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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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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® 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® 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® 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
New's Suture Scissors 5 5/8" (142mm), angled on flat
RZ-Medizintechnik GmbH
120-225-165
In Commercial Distribution

  • 04049197508414 ()
120-225-165

  • General-purpose surgical scissors, reusable
Monopolar Cable 5 mtr. 5 mm plug / 4 mm socket
Günter Bissinger Medizintechnik GmbH
80100115
In Commercial Distribution

  • 04250418700825 ()
80100115

  • Electrical-only medical device connection cable, reusable
Suture Booties, Yellow, Sterile, 5 pair/pad; 5 pads/box
KEY SURGICAL, INC.
VB-1115
In Commercial Distribution

  • 10849771019135 ()
  • 00849771019138 ()

  • Lumen/Inner Diameter: .062 Inch


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

  • D060RV520 ()


  • Dental suction system pump
GC CROWNTEK™ Refill Size, 5 crowns of Premolar 5
Gc America Inc.
412130
Not in Commercial Distribution

  • D6584121301 ()
  • D6584121300 ()
412130

  • Preformed dental crown, temporary
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
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