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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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Eyeshield OF-D3
HOYA CORPORATION
OF-D3
In Commercial Distribution

  • 04961333169047 ()


  • Scope eyepiece attachment
REVEAL POLISHING BLOCK
ORTHO ORGANIZERS, INC.
140-KT3
In Commercial Distribution

  • 00190707102890 ()


  • Interproximal reduction kit
REVEAL IPR TUBE
ORTHO ORGANIZERS, INC.
140-KT2
In Commercial Distribution

  • 00190707102883 ()


  • Interproximal reduction kit
REVEAL ARS BLOCK
ORTHO ORGANIZERS, INC.
140-KT1
In Commercial Distribution

  • 00190707102876 ()


  • Interproximal reduction kit
Microcut - 1 hacksaw frame + 2 diamond strips (fine and medium) (PT/ES/EN)
TDV DENTAL LTDA
0005000021
In Commercial Distribution

  • 07897990334078 ()
0005000021

  • Interproximal reduction kit
Microcut Refill - 5 Diamond Strips Medium
TDV DENTAL LTDA
0005000018
In Commercial Distribution

  • 07897990332401 ()
0005000018

  • Interproximal reduction kit
Microcut Manual - 10 units (EN/FR)
TDV DENTAL LTDA
0005000010
In Commercial Distribution

  • 07897990311789 ()
0005000010

  • Interproximal reduction kit
Microcut Manual - 1 unit (EN/FR)
TDV DENTAL LTDA
0005000007
In Commercial Distribution

  • 07897990302343 ()
0005000007

  • Interproximal reduction kit
Microcut Refill - 5 Diamond Strips
TDV DENTAL LTDA
0005000006
In Commercial Distribution

  • 07897990302336 ()
0005000006

  • Interproximal reduction kit
Microcut Refill - 5 Saw Blades (EN)
TDV DENTAL LTDA
0005000005
In Commercial Distribution

  • 07897990302329 ()
0005000005

  • Interproximal reduction kit
Microcut -1 hacksaw frame + 1 diamond strip (PT/ES/EN)
TDV DENTAL LTDA
0005000004
In Commercial Distribution

  • 07897990302312 ()
0005000004

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

  • D746ORX000060 ()
  • D746ORX000061 ()
ORX00006

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

  • D74640035W0 ()
  • D74640035W1 ()
40035-W

  • Interproximal reduction kit
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
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