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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® - D74640035LSBL1

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® - 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® - D74640035G1

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

  • D74640035G0 ()
  • D74640035G1 ()
40035-G

  • 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® - 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

SureSmile® - D746ORX000061

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

  • D746ORX000060 ()
  • D746ORX000061 ()
ORX00006

  • Interproximal reduction kit

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

Margin Probe Console 1.2R - 07290012534058

The MARGINPROBE System is an adjunctive diagnostic tool for identification of cancerous tissue at the margins (less than 1mm) of the main ex-vivo lumpectomy specimen following primary excision and is indicated for intraoperative use, in conjunction with standard methods (such as intraoperative imaging and palpation) in patients undergoing breast lumpectomy surgery for previously diagnosed breast cancer.
DILON MEDICAL TECHNOLOGIES LTD
SA0590020
In Commercial Distribution

  • 07290012534058 ()


  • Intraoperative tumour margin analysis probe

MarginProbe® Probe - 07290012534034

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.
DILON MEDICAL TECHNOLOGIES LTD
AC0300001
In Commercial Distribution

  • 07290012534034 ()


  • Intraoperative tumour margin analysis probe

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

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

VISIONIX - 03664188002200

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

CORTAC® - 00650551051930

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

CORTAC® - 00650551051923

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
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