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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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T-MAT G/RA Film 50SH 12.7x30.5cm
CARESTREAM HEALTH, INC.
T-MAT G/RA
Not in Commercial Distribution

  • 60889976468456 ()
  • 40889976468452 ()
  • 00889976468454 ()
6468458

  • Dental x-ray film, screen
T-MAT G/RA 50SH 12.7x30.5cm film
CARESTREAM HEALTH, INC.
T-MAT G/RA
In Commercial Distribution

  • 60889971987624 ()
  • 40889971987620 ()
  • 00889971987622 ()
1987627

  • Dental x-ray film, screen
T-MAT G/RA 50SH 8x10in film
CARESTREAM HEALTH, INC.
T-MAT G/RA
In Commercial Distribution

  • 60889978453931 ()
  • 40889978453937 ()
  • 00889978453939 ()
8453938

  • Dental x-ray film, screen
T-MAT G/RA 50SH 15x30cm film
CARESTREAM HEALTH, INC.
T-MAT G/RA
In Commercial Distribution

  • 60889971869081 ()
  • 40889971869087 ()
  • 00889971869089 ()
1869080

  • Dental x-ray film, screen
This nickel alloy can be veneered using most high melt ceramics.
Schütz Dental GmbH
622323
In Commercial Distribution

  • ESDG6223231 ()


  • Dental casting non-noble alloy
This nickel alloy can be veneered using most high melt ceramics.
Schütz Dental GmbH
622322
In Commercial Distribution

  • ESDG6223221 ()


  • Dental casting non-noble alloy
No Description
Cowellmedi Co.,Ltd
2SGH452N
In Commercial Distribution

  • 08800016106039 ()


  • Dental implant suprastructure, permanent, preformed
No Description
Cowellmedi Co.,Ltd
2SGN453N
In Commercial Distribution

  • 08800016106060 ()


  • Dental implant suprastructure, permanent, preformed
No Description
Cowellmedi Co.,Ltd
2SGN452N
In Commercial Distribution

  • 08800016106053 ()


  • Dental implant suprastructure, permanent, preformed
No Description
Cowellmedi Co.,Ltd
2SGH453N
In Commercial Distribution

  • 08800016106046 ()


  • Dental implant suprastructure, permanent, preformed
No Description
Cowellmedi Co.,Ltd
SGN45N
In Commercial Distribution

  • 08800016104493 ()


  • Dental implant suprastructure, permanent, preformed
No Description
Cowellmedi Co.,Ltd
SGH45N
In Commercial Distribution

  • 08800016104486 ()


  • Dental implant suprastructure, permanent, preformed
No Description
Cowellmedi Co.,Ltd
2SGN45N
In Commercial Distribution

  • 08800016101041 ()


  • Dental implant suprastructure, permanent, preformed
No Description
Cowellmedi Co.,Ltd
2SGH45N
In Commercial Distribution

  • 08800016101034 ()


  • Dental implant suprastructure, permanent, preformed
No Description
Cowellmedi Co.,Ltd
SGN453N
In Commercial Distribution

  • 08800016106862 ()


  • Dental implant suprastructure, permanent, preformed
No Description
Cowellmedi Co.,Ltd
SGH453N
In Commercial Distribution

  • 08800016106855 ()


  • Dental implant suprastructure, permanent, preformed
No Description
Cowellmedi Co.,Ltd
SGN452N
In Commercial Distribution

  • 08800016106800 ()


  • Dental implant suprastructure, permanent, preformed
No Description
Cowellmedi Co.,Ltd
SGH452N
In Commercial Distribution

  • 08800016106794 ()


  • Dental implant suprastructure, permanent, preformed
No Description
Lonza Walkersville, Inc.
15-1004J
In Commercial Distribution

  • 00840075403159 ()
15-1004J

  • Ex vivo cell culture medium
Status™ H. pylori card; 10 Test kit
PRINCETON BIOMEDITECH CORPORATION
BSP-406WB-10-02
In Commercial Distribution

  • 10743816001584 ()


  • Helicobacter pylori immunoglobulin M (IgM) antibody IVD, kit, enzyme immunoassay (EIA)
  • Helicobacter pylori immunoglobulin A (IgA) antibody IVD, kit, enzyme immunoassay (EIA)
  • Helicobacter pylori immunoglobulin G (IgG) antibody IVD, kit, enzyme immunoassay (EIA)
Status™ H. pylori card; 30 Test kit- CE (Procedure Card)
PRINCETON BIOMEDITECH CORPORATION
BSP-406WB-30-07
In Commercial Distribution

  • 10743816001164 ()
BSP-406WB-30-07

  • Helicobacter pylori immunoglobulin G (IgG) antibody IVD, kit, enzyme immunoassay (EIA)
  • Helicobacter pylori immunoglobulin A (IgA) antibody IVD, kit, enzyme immunoassay (EIA)
  • Helicobacter pylori immunoglobulin M (IgM) antibody IVD, kit, enzyme immunoassay (EIA)
BioSign® H. pylori card; 10 Test kit; CE
PRINCETON BIOMEDITECH CORPORATION
BSP-406WB-10-01
In Commercial Distribution

  • 10743816001140 ()
BSP-406WB-10-01

  • Helicobacter pylori immunoglobulin G (IgG) antibody IVD, kit, enzyme immunoassay (EIA)
  • Helicobacter pylori immunoglobulin A (IgA) antibody IVD, kit, enzyme immunoassay (EIA)
  • Helicobacter pylori immunoglobulin M (IgM) antibody IVD, kit, enzyme immunoassay (EIA)
Status™ H. pylori card; 25 Test kit
PRINCETON BIOMEDITECH CORPORATION
BSP-406WB-25-02
In Commercial Distribution

  • 10743816001591 ()


  • Helicobacter pylori immunoglobulin M (IgM) antibody IVD, kit, enzyme immunoassay (EIA)
  • Helicobacter pylori immunoglobulin A (IgA) antibody IVD, kit, enzyme immunoassay (EIA)
  • Helicobacter pylori immunoglobulin G (IgG) antibody IVD, kit, enzyme immunoassay (EIA)
BioSign® H. pylori card; 30 Test kit (Procedure Card)
PRINCETON BIOMEDITECH CORPORATION
BSP-406WB-30-05
In Commercial Distribution

  • 10743816001157 ()
BSP-406WB-30-05

  • Helicobacter pylori immunoglobulin G (IgG) antibody IVD, kit, enzyme immunoassay (EIA)
  • Helicobacter pylori immunoglobulin A (IgA) antibody IVD, kit, enzyme immunoassay (EIA)
  • Helicobacter pylori immunoglobulin M (IgM) antibody IVD, kit, enzyme immunoassay (EIA)
BioSign® H. pylori card; 35 Test kit; CE
PRINCETON BIOMEDITECH CORPORATION
BSP-406WB-35-01
In Commercial Distribution

  • 10743816001133 ()
BSP-406WB-35-01

  • Helicobacter pylori immunoglobulin G (IgG) antibody IVD, kit, enzyme immunoassay (EIA)
  • Helicobacter pylori immunoglobulin A (IgA) antibody IVD, kit, enzyme immunoassay (EIA)
  • Helicobacter pylori immunoglobulin M (IgM) antibody IVD, kit, enzyme immunoassay (EIA)
TEST KIT, H PYLORI (25/KT)
MCKESSON MEDICAL-SURGICAL INC.
181-37025
In Commercial Distribution

  • 00612479261518 ()
  • 00612479261501 ()
  • 00612479261495 ()


  • Helicobacter pylori immunoglobulin M (IgM) antibody IVD, kit, enzyme immunoassay (EIA)
  • Helicobacter pylori immunoglobulin A (IgA) antibody IVD, kit, enzyme immunoassay (EIA)
  • Helicobacter pylori immunoglobulin G (IgG) antibody IVD, kit, enzyme immunoassay (EIA)
TEST KIT, H PYLORI (10/KT)
MCKESSON MEDICAL-SURGICAL INC.
181-37010
In Commercial Distribution

  • 00612479261488 ()
  • 00612479261471 ()
  • 00612479261464 ()


  • Helicobacter pylori immunoglobulin M (IgM) antibody IVD, kit, enzyme immunoassay (EIA)
  • Helicobacter pylori immunoglobulin A (IgA) antibody IVD, kit, enzyme immunoassay (EIA)
  • Helicobacter pylori immunoglobulin G (IgG) antibody IVD, kit, enzyme immunoassay (EIA)
No Description
Roche Molecular Systems, Inc.
07402678190
In Commercial Distribution

  • 00875197005646 ()
07402678190

  • Beta-haemolytic Group A Streptococcus nucleic acid IVD, control
No Description
Roche Molecular Systems, Inc.
07341911190
In Commercial Distribution

  • 00875197005622 ()
07341911190

  • Beta-haemolytic Group A Streptococcus nucleic acid IVD, kit, nucleic acid technique (NAT)
No Description
THE BINDING SITE GROUP LIMITED
NK624.T.A
In Commercial Distribution

  • 05051700016926 ()


  • Total immunoglobulin A (IgA total) IVD, kit, nephelometry/turbidimetry
No Description
Roche Molecular Systems, Inc.
08403856001
In Commercial Distribution

  • 07613336156544 ()
08403856001

  • Laboratory instrument/analyser application software IVD
No Description
Roche Molecular Systems, Inc.
08085471001
In Commercial Distribution

  • 07613336129692 ()
08085471001

  • Laboratory instrument/analyser application software IVD
Xpert Xpress Strep A kit; 10 test kit
CEPHEID
XPRSTREPA-10
In Commercial Distribution

  • 07332940006372 ()
XPRSTREPA-10

  • Beta-haemolytic Group A Streptococcus nucleic acid IVD, kit, nucleic acid technique (NAT)
Xpert Xpress Strep A kit; 120 test kit
CEPHEID
XPRSTREPA-120
In Commercial Distribution

  • 07332940002503 ()
XPRSTREPA-120

  • Beta-haemolytic Group A Streptococcus nucleic acid IVD, kit, nucleic acid technique (NAT)
No Description
DIASORIN MOLECULAR LLC
MOL2860
In Commercial Distribution

  • 20816101025576 ()
MOL2860

  • Beta-haemolytic Group A Streptococcus nucleic acid IVD, control
AmpliVue GAS Assay
QUIDEL CORPORATION
Group A Strep Assay
Not in Commercial Distribution

  • 30014613312123 ()
M212

  • Beta-haemolytic Group A Streptococcus nucleic acid IVD, kit, nucleic acid technique (NAT)
Lyra Direct Strep Assay
QUIDEL CORPORATION
Direct Strep Assay
In Commercial Distribution

  • 30014613311126 ()
M112

  • Multiple Beta-haemolytic Streptococcus serogroup nucleic acid IVD, kit, nucleic acid technique (NAT)
No Description
DIASORIN MOLECULAR LLC
MOL2850
In Commercial Distribution

  • 20816101025569 ()
MOL2850

  • Beta-haemolytic Group A Streptococcus nucleic acid IVD, kit, nucleic acid technique (NAT)
Solana Strep A/C & G Assay
DIAGNOSTIC HYBRIDS, INC.
M305
In Commercial Distribution

  • 30014613336136 ()
M305

  • Multiple Beta-haemolytic Streptococcus serogroup nucleic acid IVD, kit, nucleic acid technique (NAT)
Solana GAS Assay
QUIDEL CORPORATION
Group A Strep Assay
In Commercial Distribution

  • 30014613336082 ()
M301

  • Beta-haemolytic Group A Streptococcus nucleic acid IVD, kit, nucleic acid technique (NAT)
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