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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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ACCURUN® - 00850041090009

No Description
Lgc Clinical Diagnostics, Inc.
2000-0101
In Commercial Distribution

  • 00850041090009 ()


  • Multiple infectious organism/newborn TORCH screen IVD, control

Health o meter Professional - 00854896003641

Mechanical Diaper Scale
Pelstar, LLC
YG500R
In Commercial Distribution

  • 00854896003641 ()


  • Laboratory scale, mechanical

Universal Cannula - 05051223003984

The Universal Cannula is designed to provide a port of entry into the abdominal cavity during laparoscopic & endoscopic procedures.
PURPLE SURGICAL INTERNATIONAL LIMITED
PS3506
In Commercial Distribution

  • 50551223003989 ()
  • 35051223003985 ()
  • 05051223003984 ()

  • 12mm diameter x 100mm length
PS3506

  • Cardiac sizing catheter

Trinity Biotech - 05391516747714

EIA Color Developer, 13.0 mL
MARDX DIAGNOSTICS, INC.
40-1006
In Commercial Distribution

  • 05391516747714 ()
40-1006

  • Helicobacter pylori immunoglobulin M (IgM) antibody IVD, kit, enzyme immunoassay (EIA)
  • Borrelia burgdorferi immunoglobulin G (IgG) antibody IVD, kit, enzyme immunoassay (EIA)

Tissue-Tek® Accu-Edge® - 00615233012753

Scale, Digital
SAKURA FINETEK U.S.A., INC.
0204
In Commercial Distribution

  • 00615233012753 ()
0204

  • Laboratory scale, electronic

Tissue-Tek® Accu-Edge® - 00615233012746

Scale, Economy Grade
SAKURA FINETEK U.S.A., INC.
0203
In Commercial Distribution

  • 00615233012746 ()
0203

  • Laboratory scale, mechanical

VIROTROL - 00847661005476

VIROTROL ToRCH-M (An unassayed (human) serology control.)
BIO-RAD LABORATORIES, INC.
00117B
In Commercial Distribution

  • 00847661005476 ()
00117B

  • Multiple infectious organism/newborn TORCH screen IVD, control

VIROTROL - 00847661005445

VIROTROL ToRCH Q (An unassayed (human) serology control.)
BIO-RAD LABORATORIES, INC.
00230
In Commercial Distribution

  • 00847661005445 ()
00230

  • Multiple infectious organism/newborn TORCH screen IVD, control

VIROCLEAR - 00847661002642

VIROCLEAR ToRCH (An unassayed (human) serology control.)
BIO-RAD LABORATORIES, INC.
00118
In Commercial Distribution

  • 00847661002642 ()
00118

  • Multiple infectious organism/newborn TORCH screen IVD, control

VIROTROL - 00847661002604

VIROTROL ToRCH (An unassayed (human) serology control.)
BIO-RAD LABORATORIES, INC.
00109
In Commercial Distribution

  • 00847661002604 ()
00109

  • Multiple infectious organism/newborn TORCH screen IVD, control
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