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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.
2007
In Commercial Distribution

  • 15420045501133 ()
  • 25420045501130 ()
  • 35420045501137 ()
  • 45420045501134 ()
NS2007US

  • 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.
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 VX220 is a multifunctional eye diagnostic device. There are several operation modes combined in a single platform: keratometer, corneal topographer, tonometer,and pachymeter and retro illumination
LUNEAU TECHNOLOGY OPERATIONS
VX220
In Commercial Distribution

  • 03664188002200 ()


  • Ophthalmic tonometer, battery-operated
  • Optical pachymeter
SUBDURAL GRID ELECTRODE, PLATINUM, 16 CONTACT, 4X4, RADIOPAQUE "L" AT CONTACT #1, TEXTURED, INLINE CONNECTOR, 1 EXIT, ALL CONTACTS NUMBERED
PMT CORPORATION
2110TX-16-062
In Commercial Distribution

  • 00650551051930 ()

  • Contact Diameter 3 Millimeter
  • Thickness 0.5 Millimeter
2110TX-16-062

  • Cortical electrode
SUBDURAL GRID ELECTRODE, PLATINUM, 16 CONTACT, 4X4, RADIOPAQUE "L" AT CONTACT #1, SMOOTH, INLINE CONNECTOR, 1 EXIT, ALL CONTACTS NUMBERED
PMT CORPORATION
2110-16-062
In Commercial Distribution

  • 00650551051923 ()

  • Thickness 0.5 Millimeter
  • Contact Diameter 3 Millimeter
2110-16-062

  • Cortical electrode
SUBDURAL STRIP ELECTRODE, PLATINUM, 8 CONTACT, 8X1, CONTACT #1 RADIOPAQUE, SMOOTH, IOM CONNECTOR, 1 LEFT EXIT, ALL CONTACTS REVERSE NUMBERED
PMT CORPORATION
2110-08-109
In Commercial Distribution

  • 00650551050292 ()

  • Contact Diameter 3 Millimeter
  • Thickness 0.76 Millimeter
2110-08-109

  • Cortical electrode
SUBDURAL STRIP ELECTRODE, PLATINUM, 8 CONTACT, 8X1, T-SHAPE, CONTACT #1 RADIOPAQUE, SMOOTH, INLINE CONNECTOR, 1 EXIT, ALL CONTACTS REVERSE NUMBERED
PMT CORPORATION
2110-08-107
In Commercial Distribution

  • 00650551050278 ()

  • Contact Diameter 3 Millimeter
  • Thickness 0.76 Millimeter
2110-08-107

  • Cortical electrode
SUBDURAL STRIP ELECTRODE, PLATINUM, 8 CONTACT, 8X1, CONTACT #1 RADIOPAQUE, SMOOTH, INLINE CONNECTOR, 1 LEFT EXIT, ALL CONTACTS REVERSE NUMBERED
PMT CORPORATION
2110-08-105
In Commercial Distribution

  • 00650551050254 ()

  • Contact Diameter 3 Millimeter
  • Thickness 0.76 Millimeter
2110-08-105

  • Cortical electrode
SUBDURAL STRIP ELECTRODE, PLATINUM, 8 CONTACT, 8X1, CURVED L-SHAPE, CONTACT #1 RADIOPAQUE, SMOOTH, INLINE CONNECTOR, 1 EXIT, ALL CONTACTS NUMBERED
PMT CORPORATION
2110-08-085
In Commercial Distribution

  • 00650551050018 ()

  • Thickness 0.76 Millimeter
  • Contact Diameter 3 Millimeter
2110-08-085

  • Cortical electrode
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