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

  • D74640035LSY0 ()
  • D74640035LSY1 ()
40035-LS-Y

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

  • D74640035LSW0 ()
  • D74640035LSW1 ()
40035-LS-W

  • Interproximal reduction kit
SpaceFile® IPR Strips-Left Sided-Fine/Red
DENTSPLY SIRONA ORTHODONTICS INC.
40035-LS-R
In Commercial Distribution

  • D74640035LSR0 ()
  • D74640035LSR1 ()
40035-LS-R

  • Interproximal reduction kit
SpaceFile® IPR Strips-L Sided-Finishing/Purple
DENTSPLY SIRONA ORTHODONTICS INC.
40035-LS-P
In Commercial Distribution

  • D74640035LSP0 ()
  • D74640035LSP1 ()
40035-LS-P

  • Interproximal reduction kit
SpaceFile® IPR Strips-Left Sided-Coarse/Green
DENTSPLY SIRONA ORTHODONTICS INC.
40035-LS-GR
In Commercial Distribution

  • D74640035LSGR0 ()
  • D74640035LSGR1 ()
40035-LS-GR

  • Interproximal reduction kit
SpaceFile® IPR Strips-Left Sided-Polishing/Gray
DENTSPLY SIRONA ORTHODONTICS INC.
40035-LS-G
In Commercial Distribution

  • D74640035LSG0 ()
  • D74640035LSG1 ()
40035-LS-G

  • Interproximal reduction kit
SpaceFile®IPR Strips-Left Sided-X-Coarse/Black
DENTSPLY SIRONA ORTHODONTICS INC.
40035-LS-BLK
In Commercial Distribution

  • D74640035LSBLK0 ()
  • D74640035LSBLK1 ()
40035-LS-BLK

  • 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
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