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 Class Implantable

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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
Helix Elite™ Molecular Standards Plasmodium falciparum Synthetic DNA
MICROBIOLOGICS INC.
HE0008S
Not in Commercial Distribution

  • 10845357041804 ()
HE0008S

  • Multiple-type tropical pathogen nucleic acid IVD, control
WEST EXTREMITY
MEDLINE INDUSTRIES, INC.
DYNJ904489B
In Commercial Distribution

  • 10193489509311 ()
  • 40193489509312 ()
DYNJ904489B

  • General surgical procedure kit, non-medicated, single-use
WEST MAJOR
MEDLINE INDUSTRIES, INC.
DYNJ904499B
In Commercial Distribution

  • 10193489508475 ()
  • 40193489508476 ()
DYNJ904499B

  • General surgical procedure kit, non-medicated, single-use
WEST SHOULDER
MEDLINE INDUSTRIES, INC.
DYNJ904495B
In Commercial Distribution

  • 10193489508437 ()
DYNJ904495B

  • General surgical procedure kit, non-medicated, single-use
WEST VASCULAR
MEDLINE INDUSTRIES, INC.
DYNJ904501B
In Commercial Distribution

  • 10193489506563 ()
  • 40193489506564 ()
DYNJ904501B

  • General surgical procedure kit, non-medicated, single-use
WEST EXTREMITY
MEDLINE INDUSTRIES, INC.
DYNJ904489C
In Commercial Distribution

  • 10193489618075 ()
  • 40193489618076 ()
DYNJ904489C

  • General surgical procedure kit, non-medicated, single-use
WEST MAJOR
MEDLINE INDUSTRIES, INC.
DYNJ904499C
In Commercial Distribution

  • 40193489617765 ()
  • 10193489617764 ()
DYNJ904499C

  • General surgical procedure kit, non-medicated, single-use
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