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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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PTS-X™ - 04046955677245

PTSX206 PTS-X BALLOON 20MM X 4CM X 110CM
B BRAUN INTERVENTIONAL SYSTEMS, INC
613717
In Commercial Distribution

  • 04046955677245 ()
613717

  • Cardiac sizing catheter

PTS-X™ - 04046955677221

PTSX205 PTS-X BALLOON 20MM X 3CM X 110CM
B BRAUN INTERVENTIONAL SYSTEMS, INC
613716
In Commercial Distribution

  • 04046955677221 ()
613716

  • Cardiac sizing catheter

Signify® - 10815845020079

No Description
ALERE SAN DIEGO, INC.
01P53-25
Not in Commercial Distribution

  • 10815845020079 ()
  • 00815845020072 ()


  • Helicobacter pylori immunoglobulin G (IgG) antibody IVD, kit, rapid ICT, clinical

Clearview® - 10815845020048

No Description
ALERE SAN DIEGO, INC.
92405
Not in Commercial Distribution

  • 10815845020048 ()
  • 00815845020041 ()


  • Helicobacter pylori immunoglobulin G (IgG) antibody IVD, kit, rapid ICT, clinical

Detector H. pylori - 10722355002023

Qualitative immunoassy of the detection of anti-helicobacter pylori antibodies
Immunostics Company, Inc
IHP-30
In Commercial Distribution

  • 20722355002020 ()
  • 10722355002023 ()
  • 80722355002022 ()


  • Helicobacter pylori IgG antibody IVD, kit, immunochromatographic test (ICT), rapid, professional/self-test

Detector H. pylori - 10722355002016

Qualitative immunoassy of the detection of anti-helicobacter pylori antibodies
Immunostics Company, Inc
IHP-10
In Commercial Distribution

  • 20722355002013 ()
  • 10722355002016 ()
  • 80722355002015 ()


  • Helicobacter pylori IgG antibody IVD, kit, immunochromatographic test (ICT), rapid, professional/self-test

Rapid Response - 10722066005115

COVID-19 IgG/IgM Test Cassette (Whole Blood/Serum/Plasma)
BTNX Inc
COV-13C25
In Commercial Distribution

  • 10722066005115 ()
  • 00722066005118 ()


  • SARS-CoV-2 immunoglobulin G (IgG)/IgM antibody IVD, kit, rapid ICT, clinical

Venos Occlusion Balloon Catheter - 00836559007111

Occlusion Balloon Catheter, 6F
Oscor Inc.
V0612015
Not in Commercial Distribution

  • 00836559007111 ()

  • Balloon Diameter 15 mm
  • Outer Diameter: 2 Millimeter
  • Required Syringe Size 2.0 cc
  • Length: 120 Centimeter
V0612015

  • Cardiac sizing catheter

Venos Occlusion Balloon Catheter - 00836559007104

Occlusion Balloon Catheter, 6F
Oscor Inc.
V0610015
In Commercial Distribution

  • 00836559007104 ()

  • Balloon Diameter 15 mm
  • Outer Diameter: 2 Millimeter
  • Length: 100 Centimeter
  • Required Syringe Size 2.0 cc
V0610015

  • Cardiac sizing catheter

Venos Occlusion Balloon Catheter - 00836559007098

Occlusion Balloon Catheter, 6F
Oscor Inc.
V068015
Not in Commercial Distribution

  • 00836559007098 ()

  • Required Syringe Size 2.0 cc
  • Length: 80 Centimeter
  • Balloon Diameter 15 mm
  • Outer Diameter: 2 Millimeter
V068015

  • Cardiac sizing catheter

Venos Occlusion Balloon Catheter - 00836559007081

Occlusion Balloon Catheter, 5F
Oscor Inc.
V0510015
Not in Commercial Distribution

  • 00836559007081 ()

  • Outer Diameter: 1.7 Millimeter
  • Balloon Diameter 15 mm
  • Length: 100 Centimeter
  • Required Syringe Size 2.0 cc
V0510015

  • Cardiac sizing catheter

Venos Occlusion Balloon Catheter - 00836559007074

Occlusion Balloon Catheter, 5F
Oscor Inc.
V058015
Not in Commercial Distribution

  • 00836559007074 ()

  • Outer Diameter: 1.7 Millimeter
  • Balloon Diameter 15 mm
  • Required Syringe Size 2.0 cc
  • Length: 80 Centimeter
V058015

  • Cardiac sizing catheter

Venos Occlusion Balloon Catheter - 00836559006930

Occlusion Balloon Catheter, 6F
Oscor Inc.
V0610010
In Commercial Distribution

  • 00836559006930 ()

  • Length: 100 Centimeter
  • Required Syringe Size 0.75 cc
  • Balloon Diameter 10 mm
  • Outer Diameter: 2 Millimeter
V0610010

  • Cardiac sizing catheter

Venos Occlusion Balloon Catheter - 00836559006923

Occlusion Balloon Catheter, 6F
Oscor Inc.
V068010
In Commercial Distribution

  • 00836559006923 ()

  • Balloon Diameter 10 mm
  • Required Syringe Size 0.75 cc
  • Length: 80 Centimeter
  • Outer Diameter: 2 Millimeter
V068010

  • Cardiac sizing catheter

Venos Occlusion Balloon Catheter - 00836559006916

Occlusion Balloon Catheter, 5F
Oscor Inc.
V0510010
Not in Commercial Distribution

  • 00836559006916 ()

  • Length: 100 Centimeter
  • Balloon Diameter 10 mm
  • Outer Diameter: 1.7 Millimeter
  • Required Syringe Size 0.75 cc
V0510010

  • Cardiac sizing catheter

Venos Occlusion Balloon Catheter - 00836559006909

Occlusion Balloon Catheter, 5F
Oscor Inc.
V058010
In Commercial Distribution

  • 00836559006909 ()

  • Balloon Diameter 10 mm
  • Outer Diameter: 1.7 Millimeter
  • Required Syringe Size 0.75 cc
  • Length: 80 Centimeter
V058010

  • Cardiac sizing catheter

Health o meter professional - 00892076002312

Mechanical Dial Scale
Pelstar, LLC
386KGS-01
In Commercial Distribution

  • 00892076002312 ()


  • Laboratory scale, mechanical

Nano-CheckTM COVID-19 IgG/IgM Antibody Test - 00895160002663

A in vitro diagnostic test for the qualitative detection of IgG/IgM antibodies against SARS-CoV-2 virus using human blood/serum/plasma samples.
NANO-DITECH CORPORATION
MD8145
In Commercial Distribution

  • 10895160002660 ()
  • 00895160002663 ()


  • SARS-CoV-2 immunoglobulin G (IgG)/IgM antibody IVD, kit, rapid ICT, clinical

Health o meter professional - 00892076002305

Mechanical Dial Scale
Pelstar, LLC
386S01
In Commercial Distribution

  • 00892076002305 ()


  • Laboratory scale, mechanical

VIROCLEAR - 03610522207930

VIROCLEAR SARS-CoV-2 (An unassayed (human) serology control.)
BIO-RAD LABORATORIES, INC.
200505
In Commercial Distribution

  • 03610522207930 ()
200505

  • SARS-CoV-2 immunoglobulin G (IgG) antibody IVD, control
  • SARS-CoV-2 total antibody IVD, control

VIROCLEAR - 03610522207923

VIROCLEAR SARS-CoV-2 (An unassayed (human) serology control.)
BIO-RAD LABORATORIES, INC.
200500
In Commercial Distribution

  • 03610522207923 ()
200500

  • SARS-CoV-2 immunoglobulin G (IgG) antibody IVD, control
  • SARS-CoV-2 total antibody IVD, control

VIROTROL - 03610522207893

VIROTROL SARS-CoV-2 (An unassayed (human) serology control.)
BIO-RAD LABORATORIES, INC.
200305C
In Commercial Distribution

  • 03610522207893 ()
200305C

  • SARS-CoV-2 immunoglobulin G (IgG) antibody IVD, control
  • SARS-CoV-2 total antibody IVD, control

VIROTROL - 03610522207886

VIROTROL SARS-CoV-2 (An unassayed (human) serology control.)
BIO-RAD LABORATORIES, INC.
200305B
In Commercial Distribution

  • 03610522207886 ()
200305B

  • SARS-CoV-2 immunoglobulin G (IgG) antibody IVD, control
  • SARS-CoV-2 total antibody IVD, control

VIROTROL - 03610522207879

VIROTROL SARS-CoV-2 (An unassayed (human) serology control.)
BIO-RAD LABORATORIES, INC.
200305A
In Commercial Distribution

  • 03610522207879 ()
200305A

  • SARS-CoV-2 immunoglobulin G (IgG) antibody IVD, control
  • SARS-CoV-2 total antibody IVD, control

VIROTROL - 03610522207862

VIROTROL SARS-CoV-2 (An unassayed (human) serology control.)
BIO-RAD LABORATORIES, INC.
200300C
In Commercial Distribution

  • 03610522207862 ()
200300C

  • SARS-CoV-2 immunoglobulin G (IgG) antibody IVD, control
  • SARS-CoV-2 total antibody IVD, control

VIROTROL - 03610522207855

VIROTROL SARS-CoV-2 (An unassayed (human) serology control.)
BIO-RAD LABORATORIES, INC.
200300B
In Commercial Distribution

  • 03610522207855 ()
200300B

  • SARS-CoV-2 immunoglobulin G (IgG) antibody IVD, control
  • SARS-CoV-2 total antibody IVD, control

VIROTROL - 03610522207848

VIROTROL SARS-CoV-2 (An unassayed (human) serology control.)
BIO-RAD LABORATORIES, INC.
200300A
In Commercial Distribution

  • 03610522207848 ()
200300A

  • SARS-CoV-2 immunoglobulin G (IgG) antibody IVD, control
  • SARS-CoV-2 total antibody IVD, control

VIROTROL - 03610520540718

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

  • 03610520540718 ()
00117A

  • Multiple infectious organism/newborn TORCH screen IVD, control

Teco Diagnostics H. pylori Card Test - 10673486002393

Teco Diagnostics H. pylori Card Test is an immunochromatographic assay for the qualitative determination of IgG antibodies specific to Helicobacter pylori (H. pylori) in human serum. The test is intended for professional use as an aid in the diagnosis of H. pylori infections.
TECO DIAGNOSTICS
H730-A
In Commercial Distribution

  • 10673486002393 ()
H730-A

  • Helicobacter pylori immunoglobulin G (IgG) antibody IVD, kit, rapid ICT, clinical

ACCURUN® - 00816784020147

ACCURUN 26 ToRC IgM Series 5000 3 x 1.0 mL
Lgc Clinical Diagnostics, Inc.
2000-0035
In Commercial Distribution

  • 00816784020147 ()
2000-0035

  • Multiple infectious organism/newborn TORCH screen IVD, control
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