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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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ALS CAL - 05055273200089

The Aldolase Calibration Serum is intended for in vitro diagnostic use, in the calibration of the Aldolase assay AD189.
RANDOX LABORATORIES LIMITED
AD5000
In Commercial Distribution

  • 05055273200089 ()
AD5000

  • Aldolase IVD, calibrator

Ambler Surgical - 00190660128159

Williams lacrimal probe, 5 5/8'', double-ended, size #5 and #6 olive-tip ends, malleable, sterling silver
AMBLER SURGICAL CORP.
Williams lacrimal probe
In Commercial Distribution

  • 00190660128159 ()
9834E

  • Lacrimal dilator, reusable

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

Flame photometer standard 140 Na 5K 1Li - 08426950037095

Flame photometer standard 140 Na 5K 1Li
INSTRUMENTATION LABORATORY COMPANY
00003331350
Not in Commercial Distribution

  • 08426950037095 ()
  • 18426950037092 ()
00003331350

  • Multiple electrolyte IVD, calibrator

Flame photometer standard 140 Na 5K - 08426950001805

Flame photometer standard 140 Na 5K
INSTRUMENTATION LABORATORY COMPANY
00009751750
Not in Commercial Distribution

  • 08426950001805 ()
  • 18426950001802 ()
00009751750

  • Multiple electrolyte IVD, calibrator

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

Key Surgical Suture Booties - 00849771019138

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

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

ISODAM - 05060748681904

ISODAM .15/.18mm Thin- L.Blue 5" x 5" 20 pcs
FOUR D RUBBER COMPANY LIMITED
Thin
In Commercial Distribution

  • 05060748684585 ()
  • 05060748681904 ()
DENTALFGENISO01500520

  • Rubber dam, non-latex

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

Ramvac - D060RV520

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

  • D060RV520 ()


  • Dental suction system pump

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

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

Oval Eye Pads, Sterile - 00616784335919

Oval Eye Pads, Sterile, 1 5/8"x2 5/8
Dynarex Corporation
3359
In Commercial Distribution

  • 00616784335933 ()
  • 00616784335919 ()


  • Eye pad
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