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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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The NovaSure® Impedance Controlled Endometrial Ablation System is intended to ablate the endometrial lining of the uterus in pre-menopausal women with menorrhagia (excessive bleeding) due to benign causes for whom childbearing is complete.
Hologic, Inc.
2013
In Commercial Distribution

  • 15420045501126 ()
  • 35420045501120 ()
  • 25420045501123 ()
  • 45420045501127 ()
NS2013KITUS

  • Radio-frequency endometrial-ablation system handpiece/electrode
The NovaSure® Impedance Controlled Endometrial Ablation System is intended to ablate the endometrial lining of the uterus in pre-menopausal women with menorrhagia (excessive bleeding) due to benign causes for whom childbearing is complete.
Hologic, Inc.
NS2013US
In Commercial Distribution

  • 15420045501119 ()
  • 25420045501116 ()
  • 35420045501113 ()
  • 45420045501110 ()
NS2013US

  • Radio-frequency endometrial-ablation system handpiece/electrode
The NovaSure® Impedance Controlled Endometrial Ablation System is intended to ablate the endometrial lining of the uterus in pre-menopausal women with menorrhagia (excessive bleeding) due to benign causes for whom childbearing is complete.
Hologic, Inc.
V5
In Commercial Distribution

  • 15420045514300 ()
  • 25420045514307 ()
  • 35420045514304 ()
NSV5KITUS-001

  • Radio-frequency endometrial-ablation system handpiece/electrode
The NovaSure® Impedance Controlled Endometrial Ablation System is intended to ablate the endometrial lining of the uterus in pre-menopausal women with menorrhagia (excessive bleeding) due to benign causes for whom childbearing is complete.
Hologic, Inc.
V5
In Commercial Distribution

  • 15420045514294 ()
  • 35420045514298 ()
  • 25420045514291 ()
NSV5US-001

  • Radio-frequency endometrial-ablation system handpiece/electrode
SUBDURAL GRID ELECTRODE, PLATINUM, 26 CONTACT, CONTACT #1 RADIOPAQUE, TEXTURED, INLINE CONNECTOR, 2 EXITS, 2 LEADS, 2 TAILS, NO NUMBERING
PMT CORPORATION
2110TX-26-001
In Commercial Distribution

  • 00650551143789 ()

  • Thickness 0.76 Millimeter
  • Contact Diameter 0.5 & 2 Millimeter
2110TX-26-001

  • Cortical electrode
SUBDURAL GRID ELECTRODE, PLATINUM, 26 CONTACT, CONTACT #1 RADIOPAQUE, SMOOTH, INLINE CONNECTOR, 2 EXITS, 2 LEADS, 2 TAILS, NO NUMBERING
PMT CORPORATION
2110-26-001
In Commercial Distribution

  • 00650551143765 ()

  • Thickness 0.76 Millimeter
  • Contact Diameter 0.5 & 2 Millimeter
2110-26-001

  • Cortical electrode
SEEG, 16 CONTACT, 4 X 2MM & 12 X 0.5MM CONTACT SIZE, 48MM RECORDING DEPTH, MINI CONNECTOR, REMOVABLE STYLET, 2.4MM DRILL
PMT CORPORATION
2102-16-176
In Commercial Distribution

  • 00650551000402 ()


  • Depth electrode
SEEG, 16 CONTACT, 4 X 2MM & 12 X 0.5MM CONTACT SIZE, 44.5MM RECORDING DEPTH, MINI CONNECTOR, REMOVABLE STYLET, 2.4MM DRILL
PMT CORPORATION
2102-16-175
In Commercial Distribution

  • 00650551000396 ()


  • Depth electrode
SUBDURAL STRIP ELECTRODE, STAINLESS STEEL, 8 CONTACT, 1X8, CONTACT #1 RADIOPAQUE, TEXTURED, INLINE CONNECTOR, 1 EXIT, TOP & BOTTOM ROWS NUMBERED
PMT CORPORATION
2111TX-08-037
In Commercial Distribution

  • 00650551060185 ()

  • Thickness 0.76 Millimeter
  • Contact Diameter 4.5 Millimeter
2111TX-08-037

  • Cortical electrode
SUBDURAL STRIP ELECTRODE, STAINLESS STEEL, 8 CONTACT, 1X8, CONTACT #1 RADIOPAQUE, SMOOTH, INLINE CONNECTOR, 1 EXIT, TOP & BOTTOM ROWS NUMBERED
PMT CORPORATION
2111-08-037
In Commercial Distribution

  • 00650551060178 ()

  • Thickness 0.76 Millimeter
  • Contact Diameter 4.5 Millimeter
2111-08-037

  • Cortical electrode
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