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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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SpaceFile® - D74640035BLK1

SpaceFile®IPR Strips-Dbl Sided-X Coarse Black
DENTSPLY SIRONA ORTHODONTICS INC.
40035-BLK
In Commercial Distribution

  • D74640035BLK0 ()
  • D74640035BLK1 ()
40035-BLK

  • Interproximal reduction kit

SpaceFile® - D74640035BL1

SpaceFile®IPR Strips-Dbl Sided-Medium/Blue
DENTSPLY SIRONA ORTHODONTICS INC.
40035-BL
In Commercial Distribution

  • D74640035BL0 ()
  • D74640035BL1 ()
40035-BL

  • Interproximal reduction kit

SpaceFile® - D74640034RS1

SpaceFile® IPR Strips-Right Sided Assorted
DENTSPLY SIRONA ORTHODONTICS INC.
40034-RS
In Commercial Distribution

  • D74640034RS0 ()
  • D74640034RS1 ()
40034-RS

  • Interproximal reduction kit

SpaceFile® - D74640034LS1

SpaceFile® IPR Strips-Left Sided Assorted
DENTSPLY SIRONA ORTHODONTICS INC.
40034-LS
In Commercial Distribution

  • D74640034LS0 ()
  • D74640034LS1 ()
40034-LS

  • Interproximal reduction kit

SpaceFile® - D746400341

SpaceFile®IPR Strips-Double Sided Assorted Pk 9
DENTSPLY SIRONA ORTHODONTICS INC.
40034
In Commercial Distribution

  • D746400340 ()
  • D746400341 ()
40034

  • Interproximal reduction kit

NovaSure - 15420045514300

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

NovaSure - 15420045514294

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

NovaSure - 15420045501140

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

NovaSure SureSound - 15420045501133

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

NovaSure SureSound - 15420045501126

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
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