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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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Mojo Full Face Mask, Small with Headgear - 00814747020128

Full face vented mask for use in positive pressure ventilation.
SLEEPNET, CORP.
50835
In Commercial Distribution



  • CPAP/BPAP face mask, reusable

MOX/RM3 Battery - B154R00060040000

Replacement battery for use in the MOX/RM3 control unit.
WATERS MEDICAL SYSTEMS, LLC
MOX/RM3 Battery
In Commercial Distribution

  • B154R00060040000 ()
0006004.000

  • Kidney donor-organ preservation/transport perfusion set

AnchorSeed with I-Seed - 00813787021331

AnchorSeed/TSL in FlatPack – 15 stranded seeds per mag– STERILE
THERAGENICS CORPORATION
XX77315iF
In Commercial Distribution

  • 00813787021331 ()


  • Manual brachytherapy source, permanent implant

AnchorSeed with TheraSeed® - 00813787021317

AnchorSeed/TSL in FlatPack – 15 stranded seeds per mag– STERILE
THERAGENICS CORPORATION
XX77315F
In Commercial Distribution

  • 00813787021317 ()


  • Manual brachytherapy source, permanent implant

AnchorSeed with TheraSeed® - 00813787021126

AnchorSeed in TPSII Ind.– 15 stranded seeds per mag- STERILE
THERAGENICS CORPORATION
XX77215N
In Commercial Distribution

  • 00813787021126 ()


  • Manual brachytherapy source, permanent implant

AnchorSeed with I-Seed - 00813787021119

AnchorSeed in TPSII Ind.– 15 stranded seeds per mag- STERILE
THERAGENICS CORPORATION
XX77215iN
In Commercial Distribution

  • 00813787021119 ()


  • Manual brachytherapy source, permanent implant

TheraStrand® with TheraSeed® - 00813787020853

TheraStrand with 10 seeds and 0 or spacers in Mesh
THERAGENICS CORPORATION
XX7210SM
In Commercial Distribution

  • 00813787020853 ()


  • Manual brachytherapy source, permanent implant

TheraStrand® with TheraSeed® - 00813787020839

Loose TheraStrand with 1-6 seeds, standard spacing, in TPSII Ind.
THERAGENICS CORPORATION
XX72xLN
In Commercial Distribution

  • 00813787020839 ()


  • Manual brachytherapy source, permanent implant

TheraStrand® with TheraSeed® - 00813787020792

TheraStrand TSL in Flatpack – 15 stranded seeds per mag- STERILE
THERAGENICS CORPORATION
XX7215F
In Commercial Distribution

  • 00813787020792 ()


  • Manual brachytherapy source, permanent implant

TheraSeed - 00813787020716

IsoLoader magazines in TPSII Ind. - 20 seeds per mag- STERILE
THERAGENICS CORPORATION
XX5056N
In Commercial Distribution

  • 00813787020716 ()


  • Manual brachytherapy source, permanent implant
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