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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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Sperm Washing Medium with HSA - 00810195240804

Modified HTF Medium with Human Serum Albumin (HSA). 500mL bottle.
IRVINE SCIENTIFIC, LLC
9983-500ML
In Commercial Distribution

  • 00810195240804 ()
9983

  • IVF medium

Modified HTF Medium with Gentamicin - 00810195240439

Modified HTF is a synthetic HEPES-based solution for procedures including the retrieval, handling and transfer of human gametes and embryos. This medium contains the antibiotic Gentamicin Sulfate and requires protein supplement.
IRVINE SCIENTIFIC, LLC
90126-500ML
In Commercial Distribution

  • 00810195240439 ()
90126

  • IVF medium

Sperm Washing Medium with HSA - 00810195240170

Modified HTF Medium with Human Serum Albumin (HSA). 100mL bottle.
IRVINE SCIENTIFIC, LLC
9983-100ML
In Commercial Distribution

  • 00810195240170 ()
9983

  • IVF medium

7% PVP Solution with HSA - 00810195240125

Polyvinylpyrrolidone (PVP) dissolved in mHTF (an isotonic HEPES buffered medium) to make a 7% (w/v) solution. Contains 5 mg/mL Human Serum Albumin.
IRVINE SCIENTIFIC, LLC
90121-5x0.5ML
In Commercial Distribution

  • 00810195240125 ()
90121

  • IVF medium

Elbow Mask With Pop-Off Valve - 00813830023220

No Description
ACCUTRON, INC.
47075
In Commercial Distribution

  • 00813830023220 ()
47075

  • Oxygen/air/nitrous oxide breathing gas mixer

FRU, Vacuum Connector With Barbs - 00813830021066

No Description
ACCUTRON, INC.
27324
In Commercial Distribution

  • 00813830021066 ()
27324

  • Anaesthesia workstation gas scavenger

TheraSleeve® with TheraSeed® - 00813787020969

TheraSleeve with x = 1-20 seeds and 0 or more spacers for CN
THERAGENICS CORPORATION
XX92x
Not in Commercial Distribution

  • 00813787020969 ()


  • Manual brachytherapy source, permanent implant

TheraLoad® with TheraSeed® - 00813787020945

TheraLoad with x = 1-20 seeds and 0 or more spacers for CN
THERAGENICS CORPORATION
XX82x
Not in Commercial Distribution

  • 00813787020945 ()


  • Manual brachytherapy source, permanent implant

TheraStrand® with TheraSeed® - 00813787020938

TheraStrand with x = 1-12 seeds and 0 or more spacers for CN
THERAGENICS CORPORATION
XX72x
Not in Commercial Distribution

  • 00813787020938 ()


  • Manual brachytherapy source, permanent implant

TheraStrand® with TheraSeed® - 00813787020921

Loose TheraStrand with 1-6 seeds, standard spacing, in TPSII Ind. for CN
THERAGENICS CORPORATION
XX72xLN
Not in Commercial Distribution

  • 00813787020921 ()


  • Manual brachytherapy source, permanent implant
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