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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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Tinted Glow Powder
JBC and Company
2
In Commercial Distribution

  • D85102 ()
2

  • Dental appliance fabrication material, resin
Configurable software for managing manually entered blood test results.
Rubin & Poor, Inc.
MBC 1.0B
In Commercial Distribution

  • 00860010612811 ()
2

  • Blood bank information system application software
The QuantX Breast MRI Biopsy Guidance Plugin is a software application that assists users of the QuantX software device in planning MRI guided interventional procedures.
QLARITY IMAGING, LLC
Breast MRI Biopsy Guidance Plugin
In Commercial Distribution

  • B80721 ()
2

  • Radiological PACS software
No Description
FU WAH MEDICINE CO. LIMITED
12011
Not in Commercial Distribution

  • 35177850022011 ()

  • Balloon Length: 5.4 Inch
2

  • Surgical/medical face mask, single-use
No Description
DIASORIN MOLECULAR LLC
EL0904
In Commercial Distribution

  • 10816101022080 ()
EL0904

  • Herpes simplex virus 1 & 2 (HSV1 & 2) immunoglobulin G (IgG)/IgM antibody IVD, control
No Description
DIASORIN MOLECULAR LLC
IB0910
In Commercial Distribution

  • 10816101021038 ()
IB0910

  • Herpes simplex virus 1 & 2 (HSV1 & 2) immunoglobulin G (IgG) antibody IVD, kit, immunoblot
No Description
DIASORIN MOLECULAR LLC
IB0913
In Commercial Distribution

  • 10816101021021 ()
IB0913

  • Herpes simplex virus 1 & 2 (HSV1 & 2) immunoglobulin G (IgG) antibody IVD, kit, immunoblot
No Description
DIASORIN MOLECULAR LLC
IB0900G
In Commercial Distribution

  • 20816101021004 ()
IB0900G

  • Herpes simplex virus 1 & 2 (HSV1 & 2) immunoglobulin G (IgG) antibody IVD, kit, immunoblot
Kit HSV 1/Hsv2 Qx Amplified Dna Assay
BECTON, DICKINSON AND COMPANY
441749
Not in Commercial Distribution

  • 00382904417499 ()
441749

  • Herpes simplex virus 1 & 2 (HSV1 & 2) nucleic acid IVD, kit, nucleic acid technique (NAT)
HSV-1 & HSV-2 Reagent Pack
BIO-RAD LABORATORIES, INC.
6653350
In Commercial Distribution

  • 00847865000949 ()

  • 100 Tests
6653350

  • Herpes simplex virus 1 & 2 (HSV1 & 2) immunoglobulin G (IgG) antibody IVD, kit, fluorescent immunoassay
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