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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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Snowden-Pencer - 70885403465613

Snowden-Pencer MIS TROCAR SILICONE VALVE FOR 3/3.5MM, 5.5MM PACK OF 5 5/PK X 5
STERIS CORPORATION
TSV5-5
In Commercial Distribution

  • 70885403465613 ()
  • 10885403465611 ()
TSV55

  • Laparoscopic trocar blade, reusable

LZI Norfentanyl (Q) Qualitative Calibrator - 00850624008360

NFEN Cutoff Calibrator 5 ng/mL (1 x 5 mL)
LIN-ZHI INTERNATIONAL, INC.
C68815
In Commercial Distribution

  • 00850624008360 ()
C68815

  • Fentanyl IVD, calibrator

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

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® - 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

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® - 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

OsteoMed - 00845694076883

FPS 2.7 5 Hole Straight Compression Plate Sterile Qty 5
OSTEOMED LLC
324-1101-SP-05
In Commercial Distribution

  • 00845694076883 ()

  • Length: 39 Millimeter
324-1101-SP-05

  • Orthopaedic fixation plate, non-bioabsorbable

Eleview 5mL - 05391530190466

5 ampoules, 5 mL each. To Facilitate endoscopic resection procedures
COSMO TECHNOLOGIES LIMITED
9000025
In Commercial Distribution

  • 05391530190459 ()
  • 05391530190466 ()


  • Submucosal lift solution
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