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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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KEYSTONE HEART LTD
SS-001
In Commercial Distribution

  • 00850020653003 ()

  • Catheter Gauge: 8.5 French
FG00006

  • Vascular guide-catheter, single-use
VAGINAL STENT, CYLINDRICAL, 4X11CM, 132CC FILL
PMT CORPORATION
3321-11
In Commercial Distribution

  • 00650551000693 ()


  • Skin-port tissue expander
VAGINAL STENT, CYLINDRICAL, 4X12CM, 145CC FILL
PMT CORPORATION
3321-12
In Commercial Distribution

  • 00650551000686 ()


  • Skin-port tissue expander
VAGINAL STENT, CYLINDRICAL, 4X15CM, 182CC FILL
PMT CORPORATION
3321-15
In Commercial Distribution

  • 00650551000662 ()


  • Skin-port tissue expander
VAGINAL STENT, CYLINDRICAL, 4X16.5CM, 200CC FILL
PMT CORPORATION
3321-16
In Commercial Distribution

  • 00650551000655 ()


  • Skin-port tissue expander
TE, CURVE SHAPE, SMOOTH SURFACE, INTERNAL PORT, SUTURE TABS, 4X9.5CM, 220CC FILL, 5.5CM PROJECTION
PMT CORPORATION
3614-132-2I-ST
In Commercial Distribution

  • 00650551000365 ()


  • Skin-port tissue expander
TE, RECTANGLE SHAPE, ENHANCED SURFACE, REMOTE PORT, SUTURE TABS, 15X20CM, 2000CC FILL, 9CM PROJECTION
PMT CORPORATION
3610ES-623-2
In Commercial Distribution

  • 00650551000341 ()


  • Skin-port tissue expander
TE, CURVE SHAPE, ENHANCED SURFACE, INTERNAL PORT, SUTURE TABS, 2.5X9.25CM, 100CC FILL, 4CM PROJECTION
PMT CORPORATION
3614ES-10I-ST
In Commercial Distribution

  • 00650551000327 ()


  • Skin-port tissue expander
TE, CURVE SHAPE, ENHANCED SURFACE, INTERNAL PORT, 2.5X9.25CM, 100CC FILL, 4CM PROJECTION
PMT CORPORATION
3614ES-10I
In Commercial Distribution

  • 00650551000303 ()


  • Skin-port tissue expander
TE, CURVE SHAPE, ENHANCED SURFACE, REMOTE PORT, 10X30CM, 1000CC FILL, 4.3CM PROJECTION
PMT CORPORATION
3614ES-552
In Commercial Distribution

  • 00650551000297 ()


  • Skin-port tissue expander
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