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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CABLE 2035U ELECTRICAL UMBILICAL ROHS
MEDTRONIC, INC.
2035U
In Commercial Distribution

  • 00763000279769 ()


  • Electrical-only medical device connection cable, single-use
CABLE 203CX COAXIAL UMBILICAL ROHS
MEDTRONIC, INC.
203CX
In Commercial Distribution

  • 00763000279745 ()


  • Liquid nitrous oxide coaxial tubing
CABLE 2035U ELECTRICAL UMBILICAL BMED
MEDTRONIC, INC.
2035U
In Commercial Distribution

  • 00763000359355 ()


  • Electrical-only medical device connection cable, single-use
SPYRAL CATHETER RDN016 US COMMERCIAL
MEDTRONIC, INC.
RDN016
In Commercial Distribution

  • 00763000354466 ()

  • 1.78 MM Minimum Inner Diameter
  • 1.32 MM Outer Diameter
  • 117 CM Effective Length
  • 19 MM Tip Diameter
  • 6 FR Guide Catheter
  • 0.36 MM Maximum Guidewire Diameter


  • Renal denervation radio-frequency ablation catheter
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.
NS2000US
In Commercial Distribution

  • 15420045501140 ()
  • 25420045501147 ()
  • 35420045501144 ()
NS2000US

  • 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.
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 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.
NovaSure Controller
In Commercial Distribution

  • 15420045500860 ()
RFC2010-115

  • Radio-frequency endometrial-ablation system generator
No Description
Hologic, Inc.
NovaSure Controller
In Commercial Distribution

  • 15420045500853 ()


  • Tumour-therapy radio-frequency hyperthermia system
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