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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® IPR Strips-Double Sided-Fine/Red
DENTSPLY SIRONA ORTHODONTICS INC.
40035-R
In Commercial Distribution

  • D74640035R0 ()
  • D74640035R1 ()
40035-R

  • Interproximal reduction kit
SpaceFile® IPR Strips-Dbl Sided-Finishing/Purple
DENTSPLY SIRONA ORTHODONTICS INC.
40035-P
In Commercial Distribution

  • D74640035P0 ()
  • D74640035P1 ()
40035-P

  • Interproximal reduction kit
SpaceFile® IPR Strips-Left Sided-X Fine/Yellow
DENTSPLY SIRONA ORTHODONTICS INC.
40035-LS-Y
In Commercial Distribution

  • D74640035LSY0 ()
  • D74640035LSY1 ()
40035-LS-Y

  • Interproximal reduction kit
SpaceFile® IPR Strips-Left Sided-XX Fine/White
DENTSPLY SIRONA ORTHODONTICS INC.
40035-LS-W
In Commercial Distribution

  • D74640035LSW0 ()
  • D74640035LSW1 ()
40035-LS-W

  • Interproximal reduction kit
SpaceFile® IPR Strips-Left Sided-Fine/Red
DENTSPLY SIRONA ORTHODONTICS INC.
40035-LS-R
In Commercial Distribution

  • D74640035LSR0 ()
  • D74640035LSR1 ()
40035-LS-R

  • Interproximal reduction kit
SpaceFile® IPR Strips-L Sided-Finishing/Purple
DENTSPLY SIRONA ORTHODONTICS INC.
40035-LS-P
In Commercial Distribution

  • D74640035LSP0 ()
  • D74640035LSP1 ()
40035-LS-P

  • Interproximal reduction kit
SpaceFile® IPR Strips-Left Sided-Coarse/Green
DENTSPLY SIRONA ORTHODONTICS INC.
40035-LS-GR
In Commercial Distribution

  • D74640035LSGR0 ()
  • D74640035LSGR1 ()
40035-LS-GR

  • Interproximal reduction kit
SpaceFile® IPR Strips-Left Sided-Polishing/Gray
DENTSPLY SIRONA ORTHODONTICS INC.
40035-LS-G
In Commercial Distribution

  • D74640035LSG0 ()
  • D74640035LSG1 ()
40035-LS-G

  • Interproximal reduction kit
SpaceFile®IPR Strips-Left Sided-X-Coarse/Black
DENTSPLY SIRONA ORTHODONTICS INC.
40035-LS-BLK
In Commercial Distribution

  • D74640035LSBLK0 ()
  • D74640035LSBLK1 ()
40035-LS-BLK

  • Interproximal reduction kit
SpaceFile® IPR Strips-Left Sided-Medium/Blue
DENTSPLY SIRONA ORTHODONTICS INC.
40035-LS-BL
In Commercial Distribution

  • D74640035LSBL0 ()
  • D74640035LSBL1 ()
40035-LS-BL

  • Interproximal reduction kit
SpaceFile®IPR Strips-Dbl Sided-Coarse/Green
DENTSPLY SIRONA ORTHODONTICS INC.
40035-GR
In Commercial Distribution

  • D74640035GR0 ()
  • D74640035GR1 ()
40035-GR

  • Interproximal reduction kit
SpaceFile®IPR Strips-Dbl Sided-Polishing/Gray
DENTSPLY SIRONA ORTHODONTICS INC.
40035-G
In Commercial Distribution

  • D74640035G0 ()
  • D74640035G1 ()
40035-G

  • Interproximal reduction kit
SpaceFile®IPR Coping Saw /Gold (Brown)
DENTSPLY SIRONA ORTHODONTICS INC.
40035-CS
In Commercial Distribution

  • D74640035CS0 ()
  • D74640035CS1 ()
40035-CS

  • Interproximal reduction kit
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®IPR Strips-Dbl Sided-Medium/Blue
DENTSPLY SIRONA ORTHODONTICS INC.
40035-BL
In Commercial Distribution

  • D74640035BL0 ()
  • D74640035BL1 ()
40035-BL

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

  • D74640034RS0 ()
  • D74640034RS1 ()
40034-RS

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

  • D74640034LS0 ()
  • D74640034LS1 ()
40034-LS

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

  • D746400340 ()
  • D746400341 ()
40034

  • Interproximal reduction kit
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
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