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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-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
Drill Gauge
MEDICAL DESIGNS LLC
11-1109-FD12
In Commercial Distribution

  • 11110912 ()
  • M111109FD120 ()


  • Sacroiliac joint transarticular fixation/arthrodesis implantation kit
No Description
Gebr. Brasseler GmbH & Co. KG
HU34L.314.012.A2
In Commercial Distribution

  • E226041847A28 ()
  • E226041847A21 ()
HU34L.314.012

  • Carbide dental bur, reusable
No Description
Gebr. Brasseler GmbH & Co. KG
HU34.314.012.AU
In Commercial Distribution

  • E226041846AU8 ()
  • E226041846AU1 ()
HU34.314.012

  • Carbide dental bur, reusable
No Description
Gebr. Brasseler GmbH & Co. KG
HU34.314.012.A6
In Commercial Distribution

  • E226041846A68 ()
  • E226041846A61 ()
HU34.314.012

  • Carbide dental bur, reusable
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