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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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Diamedix - 00817273020044

"300-371A Rubella IgM Capture Lyoph. Ag. Accessory Kit"
DIAMEDIX CORPORATION
300-371A
In Commercial Distribution

  • 00817273020044 ()


  • Multiple infectious organism/newborn TORCH screen IVD, kit, enzyme immunoassay (EIA)

Varicella Zoster Virus Antigen Substrate, 12 wells, For IFA Test System - B110VZ70120

No Description
Bion Enterprises, Ltd.
VZ-7012
In Commercial Distribution

  • B110VZ70120 ()
VZ-7012

  • Varicella-zoster virus (VZV) immunoglobulin M (IgM) antibody IVD, reagent
  • Varicella-zoster virus (VZV) immunoglobulin G (IgG) antibody IVD, reagent

Amplatzer™ - 00811806011523

Sizing Balloon II
ST. JUDE MEDICAL, INC.
9-SB-024
In Commercial Distribution

  • 00811806011523 ()

  • Outer Diameter: 24.0000 Millimeter
  • Length: 70.0000 Centimeter
9-SB-024

  • Cardiac sizing catheter

Amplatzer™ - 00811806011516

Sizing Balloon II
ST. JUDE MEDICAL, INC.
9-SB-018
In Commercial Distribution

  • 00811806011516 ()

  • Length: 70.0000 Centimeter
  • Outer Diameter: 18.0000 Millimeter
9-SB-018

  • Cardiac sizing catheter

Herpes Simplex Negative Control - B110HSN35100

No Description
Bion Enterprises, Ltd.
HSN-3510
In Commercial Distribution

  • B110HSN35100 ()
HSN-3510

  • Herpes simplex virus 1 & 2 (HSV1 & 2) immunoglobulin M (IgM) antibody IVD, control
  • Herpes simplex virus 1 & 2 (HSV1 & 2) immunoglobulin G (IgG) antibody IVD, control

EasyFlow Duo Cannula - 00803622128073

No Description
LIVANOVA USA, INC.
Duo Cannula
In Commercial Distribution

  • 10803622128070 ()
  • 00803622128073 ()


  • Aorta cannula

Amplatzer™ - 00811806011530

Sizing Balloon II
ST. JUDE MEDICAL, INC.
9-SB-034
In Commercial Distribution

  • 00811806011530 ()

  • Length: 70.0000 Centimeter
  • Outer Diameter: 34.0000 Millimeter
9-SB-034

  • Cardiac sizing catheter

Argyle - 10884527007103

CPAP Nasal Cannula with Bonnet,Babies 1000 g >1500 g
Cardinal Health, Inc.
8888163030
In Commercial Distribution

  • 20884527007100 ()
  • 10884527007103 ()

  • Clothing Size,Small,N/A;
8888163030

  • Nasal oxygen cannula, CPAP

SAFIRA - 05060727270068

SAFIRA System hand operator for controlling SAFIRA Driver
MEDOVATE LIMITED
SAFIRA Palm Operator
In Commercial Distribution

  • 05060727270068 ()
900059

  • Pain management medication delivery system

SAFIRA - 05060727270051

Sterile SAFIRA 20 mL syringe (NRFit)
MEDOVATE LIMITED
SAFIRA NRFit Syringe
In Commercial Distribution

  • 35060727270052 ()
  • 05060727270051 ()
900058

  • Pain management medication delivery system
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