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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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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

CORTAC® - 00650551050292

SUBDURAL STRIP ELECTRODE, PLATINUM, 8 CONTACT, 8X1, CONTACT #1 RADIOPAQUE, SMOOTH, IOM CONNECTOR, 1 LEFT EXIT, ALL CONTACTS REVERSE NUMBERED
PMT CORPORATION
2110-08-109
In Commercial Distribution

  • 00650551050292 ()

  • Contact Diameter 3 Millimeter
  • Thickness 0.76 Millimeter
2110-08-109

  • Cortical electrode

CORTAC® - 00650551050278

SUBDURAL STRIP ELECTRODE, PLATINUM, 8 CONTACT, 8X1, T-SHAPE, CONTACT #1 RADIOPAQUE, SMOOTH, INLINE CONNECTOR, 1 EXIT, ALL CONTACTS REVERSE NUMBERED
PMT CORPORATION
2110-08-107
In Commercial Distribution

  • 00650551050278 ()

  • Contact Diameter 3 Millimeter
  • Thickness 0.76 Millimeter
2110-08-107

  • Cortical electrode

CORTAC® - 00650551050254

SUBDURAL STRIP ELECTRODE, PLATINUM, 8 CONTACT, 8X1, CONTACT #1 RADIOPAQUE, SMOOTH, INLINE CONNECTOR, 1 LEFT EXIT, ALL CONTACTS REVERSE NUMBERED
PMT CORPORATION
2110-08-105
In Commercial Distribution

  • 00650551050254 ()

  • Contact Diameter 3 Millimeter
  • Thickness 0.76 Millimeter
2110-08-105

  • Cortical electrode

CORTAC® - 00650551050018

SUBDURAL STRIP ELECTRODE, PLATINUM, 8 CONTACT, 8X1, CURVED L-SHAPE, CONTACT #1 RADIOPAQUE, SMOOTH, INLINE CONNECTOR, 1 EXIT, ALL CONTACTS NUMBERED
PMT CORPORATION
2110-08-085
In Commercial Distribution

  • 00650551050018 ()

  • Thickness 0.76 Millimeter
  • Contact Diameter 3 Millimeter
2110-08-085

  • Cortical electrode

CORTAC® - 00650551050001

SUBDURAL STRIP ELECTRODE, PLATINUM, 8 CONTACT, 8X1, CURVED L-SHAPE, CONTACT #1 RADIOPAQUE, SMOOTH, INLINE CONNECTOR, 1 EXIT, ALL CONTACTS NUMBERED
PMT CORPORATION
2110-08-084
In Commercial Distribution

  • 00650551050001 ()

  • Thickness 0.76 Millimeter
  • Contact Diameter 3 Millimeter
2110-08-084

  • Cortical electrode

CORTAC® - 00650551049388

SUBDURAL STRIP ELECTRODE, PLATINUM, 8 CONTACT, 1X8, CONTACT #1 & #8 RADIOPAQUE, SMOOTH, INLINE CONNECTOR, 1 EXIT, TOP & BOTTOM ROWS NUMBERED
PMT CORPORATION
2110-08-039
In Commercial Distribution

  • 00650551049388 ()

  • Contact Diameter 4.5 Millimeter
  • Thickness 0.76 Millimeter
2110-08-039

  • Cortical electrode

CORTAC® - 00650551048985

SUBDURAL STRIP ELECTRODE, PLATINUM, 6 CONTACT, 6X1, T-SHAPE, CONTACT #1 RADIOPAQUE, SMOOTH, IOM CONNECTOR, 1 EXIT, ALL CONTACTS REVERSE NUMBERED
PMT CORPORATION
2110-06-111
In Commercial Distribution

  • 00650551048985 ()

  • Thickness 0.76 Millimeter
  • Contact Diameter 3 Millimeter
2110-06-111

  • Cortical electrode

CORTAC® - 00650551048961

SUBDURAL STRIP ELECTRODE, PLATINUM, 6 CONTACT, 6X1, CONTACT #1 RADIOPAQUE, SMOOTH, IOM CONNECTOR, 1 LEFT EXIT, ALL CONTACTS REVERSE NUMBERED
PMT CORPORATION
2110-06-109
In Commercial Distribution

  • 00650551048961 ()

  • Thickness 0.76 Millimeter
  • Contact Diameter 3 Millimeter
2110-06-109

  • Cortical electrode

CORTAC® - 00650551048947

SUBDURAL STRIP ELECTRODE, PLATINUM, 6 CONTACT, 6X1, T-SHAPE, CONTACT #1 RADIOPAQUE, SMOOTH, INLINE CONNECTOR, 1 EXIT, ALL CONTACTS REVERSE NUMBERED
PMT CORPORATION
2110-06-107
In Commercial Distribution

  • 00650551048947 ()

  • Thickness 0.76 Millimeter
  • Contact Diameter 3 Millimeter
2110-06-107

  • Cortical electrode

CORTAC® - 00650551048466

SUBDURAL STRIP ELECTRODE, PLATINUM, 6 CONTACT, 1X6, CONTACT #1 & #6 RADIOPAQUE, SMOOTH, INLINE CONNECTOR, 1 EXIT, TOP & BOTTOM ROWS NUMBERED
PMT CORPORATION
2110-06-053
In Commercial Distribution

  • 00650551048466 ()

  • Contact Diameter 4.5 Millimeter
  • Thickness 0.76 Millimeter
2110-06-053

  • Cortical electrode

CORTAC® - 00650551047742

SUBDURAL STRIP ELECTRODE, PLATINUM, 4 CONTACT, 1X4, CONTACT #1 RADIOPAQUE, SMOOTH, INLINE CONNECTOR, 1 EXIT, ALL CONTACTS NUMBERED, PERFORATED HOLES
PMT CORPORATION
2110-04-101
In Commercial Distribution

  • 00650551047742 ()

  • Thickness 0.76 Millimeter
  • Contact Diameter 3 Millimeter
2110-04-101

  • Cortical electrode

CORTAC® - 00650551047339

SUBDURAL STRIP ELECTRODE, PLATINUM, 4 CONTACT, 1X4, CONTACT #1 & #4 RADIOPAQUE, SMOOTH, INLINE CONNECTOR, 1 EXIT, TOP & BOTTOM ROWS NUMBERED
PMT CORPORATION
2110-04-053
In Commercial Distribution

  • 00650551047339 ()

  • Thickness 0.76 Millimeter
  • Contact Diameter 4.5 Millimeter
2110-04-053

  • Cortical electrode

CORTAC® - 00650551047155

SUBDURAL STRIP ELECTRODE, PLATINUM, 4 CONTACT, 1X4, CONTACT #1 & #4 RADIOPAQUE, SMOOTH, INLINE CONNECTOR, 1 EXIT, TOP & BOTTOM ROWS NUMBERED
PMT CORPORATION
2110-04-039
In Commercial Distribution

  • 00650551047155 ()

  • Thickness 0.76 Millimeter
  • Contact Diameter 4.5 Millimeter
2110-04-039

  • Cortical electrode

DEPTHALON - 00650551000402

SEEG, 16 CONTACT, 4 X 2MM & 12 X 0.5MM CONTACT SIZE, 48MM RECORDING DEPTH, MINI CONNECTOR, REMOVABLE STYLET, 2.4MM DRILL
PMT CORPORATION
2102-16-176
In Commercial Distribution

  • 00650551000402 ()


  • Depth electrode

DEPTHALON - 00650551000396

SEEG, 16 CONTACT, 4 X 2MM & 12 X 0.5MM CONTACT SIZE, 44.5MM RECORDING DEPTH, MINI CONNECTOR, REMOVABLE STYLET, 2.4MM DRILL
PMT CORPORATION
2102-16-175
In Commercial Distribution

  • 00650551000396 ()


  • Depth electrode

CORTAC® - 00650551051336

SUBDURAL GRID ELECTRODE, PLATINUM, 16 CONTACT, 4X4, TOP RIGHT CONTACT RADIOPAQUE, SMOOTH, MINI CONNECTOR, 1 EXIT, TOP & BOTTOM ROWS NUMBERED
PMT CORPORATION
2110-16-005
In Commercial Distribution

  • 00650551051336 ()

  • Contact Diameter 3 Millimeter
  • Thickness 0.76 Millimeter
2110-16-005

  • Cortical electrode

CORTAC® - 00650551050605

SUBDURAL STRIP ELECTRODE, PLATINUM, 10 CONTACT, 1X10, CONTACT #1 & #10 RADIOPAQUE, SMOOTH, INLINE CONNECTOR, 1 EXIT, TOP & BOTTOM ROWS NUMBERED
PMT CORPORATION
2110-10-039
In Commercial Distribution

  • 00650551050605 ()

  • Thickness 0.76 Millimeter
  • Contact Diameter 4.5 Millimeter
2110-10-039

  • Cortical electrode

CORTAC® - 00650551050483

SUBDURAL GRID ELECTRODE, PLATINUM, 10 CONTACT, 2X5, TOP RIGHT CONTACT RADIOPAQUE, TEXTURED, INLINE CONNECTOR, 1 EXIT, TOP & BOTTOM ROWS NUMBERED
PMT CORPORATION
2110TX-10-007
In Commercial Distribution

  • 00650551050483 ()

  • Contact Diameter 3 Millimeter
  • Thickness 0.5 Millimeter
2110TX-10-007

  • Cortical electrode

CORTAC® - 00650551050476

SUBDURAL GRID ELECTRODE, PLATINUM, 10 CONTACT, 2X5, TOP RIGHT CONTACT RADIOPAQUE, SMOOTH, INLINE CONNECTOR, 1 EXIT, TOP & BOTTOM ROWS NUMBERED
PMT CORPORATION
2110-10-007
In Commercial Distribution

  • 00650551050476 ()

  • Thickness 0.5 Millimeter
  • Contact Diameter 3 Millimeter
2110-10-007

  • Cortical electrode

CORTAC® - 00650551050315

SUBDURAL STRIP ELECTRODE, PLATINUM, 8 CONTACT, 8X1, T-SHAPE, CONTACT #1 RADIOPAQUE, SMOOTH, IOM CONNECTOR, 1 EXIT, ALL CONTACTS REVERSE NUMBERED
PMT CORPORATION
2110-08-111
In Commercial Distribution

  • 00650551050315 ()

  • Contact Diameter 3 Millimeter
  • Thickness 0.76 Millimeter
2110-08-111

  • Cortical electrode
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