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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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MarginProbe® Probe - 07290012534010

The probe is a detachable, sterile, single-use, single-patient component with a 3-year shelf life. It is connected to the console by two RF cables and a vacuum tube, via a single connector.
DUNE MEDICAL DEVICES LTD
AC0300001
In Commercial Distribution

  • 07290012534010 ()


  • Intraoperative tumour margin analysis probe

IPR Lamineer Tips - 07350081495664

2x Inter-Proximal Reduction Lamineer Tips for Profin Reciprocating Contra-Angles 0.2mm Blade Thickness, Double Sided 40 Micron Diamond Coating
Dentatus AB
LTA-P2/2
In Commercial Distribution

  • 07350081495664 ()
LTA-P2/2

  • Interproximal reduction kit

IPR Lamineer Tips - 07350081495657

2x Inter-Proximal Reduction Lamineer Tips for Profin Reciprocating Contra-Angles 0.1mm Blade Thickness, Double Sided 15 Micron Diamond Coating
Dentatus AB
LTA-P1/2
In Commercial Distribution

  • 07350081495657 ()
LTA-P1/2

  • Interproximal reduction kit

IPR Lamineer Tips - 07350081495640

5x Assorted Inter-Proximal Reduction Lamineer Tips for Profin Reciprocating Contra-Angles 1 of each of the following: 0.1mm Blade Thickness, Double Sided 15 Micron Diamond Coating 0.2mm Blade Thickness, Double Sided 40 Micron Diamond Coating 0.3mm Blade Thickness, Double Sided 50 Micron Diamond Coating 0.4mm Blade Thickness, Double Sided 50 Micron Diamond Coating 0.5mm Blade Thickness, Double Sided 50 Micron Diamond Coating
Dentatus AB
LTA-P/SK2
In Commercial Distribution

  • 07350081495640 ()
LTA-P/SK2

  • Interproximal reduction kit

IPR Lamineer Tips - 07350081494933

2x Inter-Proximal Reduction Lamineer Tips for Profin Reciprocating Contra-Angles 0.5mm Blade Thickness, Double Sided 50 Micron Diamond Coating
Dentatus AB
LTA-P5/2
In Commercial Distribution

  • 07350081494933 ()
LTA-P5/2

  • Interproximal reduction kit

IPR Lamineer Tips - 07350081494926

2x Inter-Proximal Reduction Lamineer Tips for Profin Reciprocating Contra-Angles 0.4mm Blade Thickness, Double Sided 50 Micron Diamond Coating
Dentatus AB
LTA-P4/2
In Commercial Distribution

  • 07350081494926 ()
LTA-P4/2

  • Interproximal reduction kit

IPR Lamineer Tips - 07350081494919

2x Inter-Proximal Reduction Lamineer Tips for Profin Reciprocating Contra-Angles 0.3mm Blade Thickness, Double Sided 50 Micron Diamond Coating
Dentatus AB
LTA-P3/2
In Commercial Distribution

  • 07350081494919 ()
LTA-P3/2

  • Interproximal reduction kit

IPR Lamineer Tips - 07350081494902

2x Inter-Proximal Reduction Lamineer Tips for Profin Reciprocating Contra-Angles 0.25mm Blade Thickness, Single Sided, Right Side 50 Micron Diamond Coating
Dentatus AB
LTA-P25R/2
In Commercial Distribution

  • 07350081494902 ()
LTA-P25R/2

  • Interproximal reduction kit

IPR Lamineer Tips - 07350081494896

2x Inter-Proximal Reduction Lamineer Tips for Profin Reciprocating Contra-Angles 0.25mm Blade Thickness, Single Sided, Left Side 50 Micron Diamond Coating
Dentatus AB
LTA-P25L/2
In Commercial Distribution

  • 07350081494896 ()
LTA-P25L/2

  • 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

NovaSure - 15420045501119

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

SpaceFile® - D74640035W1

SpaceFile® IPR Strips-Double Sided-XX Fine/White
DENTSPLY SIRONA ORTHODONTICS INC.
40035-W
In Commercial Distribution

  • D74640035W0 ()
  • D74640035W1 ()
40035-W

  • Interproximal reduction kit

SpaceFile® - D74640035RSW1

SpaceFile® IPR Strips-Right Sided-XX Fine/White
DENTSPLY SIRONA ORTHODONTICS INC.
40035-RS-W
In Commercial Distribution

  • D74640035RSW0 ()
  • D74640035RSW1 ()
40035-RS-W

  • Interproximal reduction kit

SpaceFile® - D74640035RSP1

SpaceFile®IPR Strips-R Sided-Finishing/Purple
DENTSPLY SIRONA ORTHODONTICS INC.
40035-RS-P
In Commercial Distribution

  • D74640035RSP0 ()
  • D74640035RSP1 ()
40035-RS-P

  • Interproximal reduction kit

SpaceFile® - D74640035RSG1

SpaceFile® IPR Strips-Right Sided-Polishing/Gray
DENTSPLY SIRONA ORTHODONTICS INC.
40035-RS-G
In Commercial Distribution

  • D74640035RSG0 ()
  • D74640035RSG1 ()
40035-RS-G

  • Interproximal reduction kit

SpaceFile® - D74640035GR1

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

  • D74640035GR0 ()
  • D74640035GR1 ()
40035-GR

  • Interproximal reduction kit

SpaceFile® - D74640035CS1

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

  • D74640035CS0 ()
  • D74640035CS1 ()
40035-CS

  • 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® - D746400341

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

  • D746400340 ()
  • D746400341 ()
40034

  • Interproximal reduction kit

SureSmile® - D746ORX000061

SureSmile Aligner Starter Kit (Doctor Kit)
DENTSPLY SIRONA ORTHODONTICS INC.
ORX00006
In Commercial Distribution

  • D746ORX000060 ()
  • D746ORX000061 ()
ORX00006

  • Interproximal reduction kit

SpaceFile® - D74640035Y1

SpaceFile® IPR Strips-Double Sided-X Fine/Yellow
DENTSPLY SIRONA ORTHODONTICS INC.
40035-Y
In Commercial Distribution

  • D74640035Y0 ()
  • D74640035Y1 ()
40035-Y

  • Interproximal reduction kit

SpaceFile® - D74640035RSY1

SpaceFile® IPR Strips-Right Sided-X Fine/Yellow
DENTSPLY SIRONA ORTHODONTICS INC.
40035-RS-Y
In Commercial Distribution

  • D74640035RSY0 ()
  • D74640035RSY1 ()
40035-RS-Y

  • Interproximal reduction kit

SpaceFile® - D74640035RSR1

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

  • D74640035RSR0 ()
  • D74640035RSR1 ()
40035-RS-R

  • Interproximal reduction kit

SpaceFile® - D74640035RSGR1

SpaceFile® IPR Strips-Right Sided-Coarse/Green
DENTSPLY SIRONA ORTHODONTICS INC.
40035-RS-GR
In Commercial Distribution

  • D74640035RSGR0 ()
  • D74640035RSGR1 ()
40035-RS-GR

  • Interproximal reduction kit

SpaceFile® - D74640035RSBLK1

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

  • D74640035RSBLK0 ()
  • D74640035RSBLK1 ()
40035-RS-BLK

  • Interproximal reduction kit
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