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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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PERIOSTEAL WEST, 18,5 CM
BMT Medizintechnik GmbH
WEST
In Commercial Distribution

  • 04251725218089 ()
WEST

  • Periosteal elevator, reusable
VIROTROL WNV (An unassayed (human) serology control.)
BIO-RAD LABORATORIES, INC.
00116
In Commercial Distribution

  • 00847661002628 ()
00116

  • West Nile virus immunoglobulin A (IgA)/IgG/IgM antibody IVD, control
No Description
ATOM MEDICAL CORPORATION
60366
In Commercial Distribution

  • 04942962603669 ()
60366

  • Apgar score timer
Apgar-Timer for standard rail (10x25mm)
Medela AG
017.0015
In Commercial Distribution

  • 07612367017428 ()


  • Apgar score timer
No Description
SALVIN DENTAL SPECIALTIES, LLC
West
In Commercial Distribution

  • 00841336102460 ()


  • Dental elevator, tooth/root
ImmunoCAP Allergen Rt218, Virginia live oak
Phadia AB
14-5252-10
In Commercial Distribution

  • 07333066009155 ()
14-5252-10

  • Allergen-specific immunoglobulin E (IgE) antibody IVD, kit, enzyme immunoassay (EIA)
Helix Elite™ Molecular Standards West Nile Virus Synthetic RNA
MICROBIOLOGICS INC.
HE0014S
Not in Commercial Distribution

  • 10845357041866 ()
HE0014S

  • Multiple-type tropical pathogen nucleic acid IVD, control
Helix Elite™ Molecular Standards Plasmodium malariae Synthetic DNA
MICROBIOLOGICS INC.
HE0011S
Not in Commercial Distribution

  • 10845357041835 ()
HE0011S

  • Multiple-type tropical pathogen nucleic acid IVD, control
Helix Elite™ Molecular Standards Plasmodium ovale Synthetic DNA
MICROBIOLOGICS INC.
HE0010S
Not in Commercial Distribution

  • 10845357041828 ()
HE0010S

  • Multiple-type tropical pathogen nucleic acid IVD, control
Helix Elite™ Molecular Standards Plasmodium vivax Synthetic DNA
MICROBIOLOGICS INC.
HE0009S
Not in Commercial Distribution

  • 10845357041811 ()
HE0009S

  • Multiple-type tropical pathogen nucleic acid IVD, control
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