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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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Reveal® - 00190707102876

REVEAL ARS BLOCK
ORTHO ORGANIZERS, INC.
140-KT1
In Commercial Distribution

  • 00190707102876 ()


  • Interproximal reduction kit

MICROCUT - 07897990332401

Microcut Refill - 5 Diamond Strips Medium
TDV DENTAL LTDA
0005000018
In Commercial Distribution

  • 07897990332401 ()
0005000018

  • Interproximal reduction kit

MICROCUT MANUAL - 07897990311789

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

  • 07897990311789 ()
0005000010

  • Interproximal reduction kit

MICROCUT MANUAL - 07897990302343

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

  • 07897990302343 ()
0005000007

  • Interproximal reduction kit

MICROCUT - 07897990302336

Microcut Refill - 5 Diamond Strips
TDV DENTAL LTDA
0005000006
In Commercial Distribution

  • 07897990302336 ()
0005000006

  • Interproximal reduction kit

MICROCUT - 07897990302329

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

  • 07897990302329 ()
0005000005

  • 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 - 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
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