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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Fraxion Head Mask (10 pcs.) Efficast 2 mm micro
Orfit Industries NV
45215-BOX10
In Commercial Distribution

  • 05420028777510 ()


  • Head/neck procedure positioner
MD Head Support - Model 7 Asian Version For other hardware
Orfit Industries NV
32426-MD
In Commercial Distribution

  • 05420028777503 ()


  • DNA-based tissue typing IVD, reagent
AIO Paediatric Base Plate in CFL shoulder slots - no Leg separator
Orfit Industries NV
32301-PED/SS/NOLS
In Commercial Distribution

  • 05420028777428 ()


  • Radiological whole-body positioner
HP PRO Extension Base Plate with Pin Interface - Paediatric 8-16y
Orfit Industries NV
25000/16
In Commercial Distribution

  • 05420028777282 ()


  • Radiological whole-body positioner
Comfort Cushion with Aluminium Post for Sagittilt
Orfit Industries NV
32070/16
In Commercial Distribution

  • 05420028777268 ()


  • DNA-based tissue typing IVD, reagent
3pt Mask for HP PRO Solution - No Nose Hole Nanor 1.6 mm Micro+
Orfit Industries NV
25100/16MI+N/NH
In Commercial Distribution

  • 05420028777138 ()


  • Radiological whole-body positioner
AIO Lateral Fixation Set - Bridge Bar Tomotherapy Couch
Orfit Industries NV
33129
In Commercial Distribution

  • 05420028777060 ()


  • Radiological whole-body positioner
5pt Mask for HP PRO Solution Nanor 2.0 mm Micro+
Orfit Industries NV
25105/2MI+N
In Commercial Distribution

  • 05420028777039 ()


  • Radiological whole-body positioner
3pt Mask for HP PRO Solution Nanor 1.6 mm Micro+
Orfit Industries NV
25100/16MI+N
In Commercial Distribution

  • 05420028777022 ()


  • Radiological whole-body positioner
AIO Lateral Fixation Set - Table Fix Couch 52cm
Orfit Industries NV
33145
In Commercial Distribution

  • 05420028776957 ()


  • Radiological whole-body positioner
5pt Hybrid HNS Mask - No Nose Hole + Tracheo Hole Eff 2MA - Nanor 12MI+
Orfit Industries NV
33730/2MA/12MI+N/NH/G17
In Commercial Distribution

  • 05420028776940 ()


  • Head/neck procedure positioner
Push pin set for Duon masks
Orfit Industries NV
60164/5
In Commercial Distribution

  • 05420028776865 ()


  • Head/neck procedure positioner
SBRT Short Anti-tilt Fixation Indexing pins - iBeam® Couch Top
Orfit Industries NV
33131
In Commercial Distribution

  • 05420028776841 ()


  • Radiological whole-body positioner
Wedge 13.5° in High Density rigid PE
Orfit Industries NV
35754/5
In Commercial Distribution

  • 05420028776728 ()


  • DNA-based tissue typing IVD, reagent
2-Pin Bar Set - Non Indexed Couch Top 50cm 12mm Base Plate
Orfit Industries NV
33121
In Commercial Distribution

  • 05420028775912 ()


  • DNA-based tissue typing IVD, reagent
5pt H&N&S Mask -No Nose Hole
Orfit Industries NV
35791/2MA/NH/NP
In Commercial Distribution

  • 05420028775219 ()


  • Head/neck procedure positioner
HP PRO Solution - Hand hold B
Orfit Industries NV
25000/17/B
In Commercial Distribution

  • 05420028775042 ()


  • Radiological whole-body positioner
HP PRO Solution - Hand hold A
Orfit Industries NV
25000/17/A
In Commercial Distribution

  • 05420028775011 ()


  • Radiological whole-body positioner
AIO Anti-tilt Fixation - 2-pin Bar iBeam® Couch Top - MRI compatible
Orfit Industries NV
33158
In Commercial Distribution

  • 05420028774847 ()


  • Radiological whole-body positioner
HP Long Base Plate in CFL - IMRT- Hexapod for Head, Neck & Shoulders - Low Density
Orfit Industries NV
32150/HX
In Commercial Distribution

  • 05420028774434 ()


  • DNA-based tissue typing IVD, reagent
2-Pin Bar Set - Non Indexed Couch Top 53cm 12mm Base Plate
Orfit Industries NV
33120
In Commercial Distribution

  • 05420028774403 ()


  • DNA-based tissue typing IVD, reagent
MRI-P Solution Head, Neck & Shoulders
Orfit Industries NV
29111-P
In Commercial Distribution

  • 05420028774243 ()


  • DNA-based tissue typing IVD, reagent
Pinpoint Indexing Block for 30 mm base plates (set of 4 blocks)
Orfit Industries NV
32822
In Commercial Distribution

  • 05420028774229 ()


  • DNA-based tissue typing IVD, reagent
AIO Anti-tilt Fixation - Bridge Bar iBeam® Couch Top - MRI compatible
Orfit Industries NV
33139
In Commercial Distribution

  • 05420028774113 ()


  • Radiological whole-body positioner
High Precision Lung Board Solution
Orfit Industries NV
29115
In Commercial Distribution

  • 05420028773895 ()


  • DNA-based tissue typing IVD, reagent
Aluminium Post for Sagittilt
Orfit Industries NV
32070/15
In Commercial Distribution

  • 05420028773499 ()


  • DNA-based tissue typing IVD, reagent
Adapter for AIO Plate in CFL Hexapod
Orfit Industries NV
32301/HXA
In Commercial Distribution

  • 05420028773208 ()


  • Radiological whole-body positioner
LD Head Support Interface for push-pin Base Plate
Orfit Industries NV
32149
In Commercial Distribution

  • 05420028773147 ()


  • DNA-based tissue typing IVD, reagent
AIO Lateral Fixation Set Couch 53cm - MRI compatible
Orfit Industries NV
33166
In Commercial Distribution

  • 05420028772898 ()


  • Radiological whole-body positioner
MRI-G Solution Head, Neck & Shoulders
Orfit Industries NV
29111-G
In Commercial Distribution

  • 05420028772690 ()


  • DNA-based tissue typing IVD, reagent
AIO-LOXON™ Set - Exact™ Couch Top 2 pairs - MRI compatible
Orfit Industries NV
33146
In Commercial Distribution

  • 05420028772638 ()


  • Radiological whole-body positioner
DUON UH-HEAD MASK 2.4MM MICRO+
Orfit Industries NV
60119-UH
In Commercial Distribution

  • 05420028772584 ()


  • Tone audiometer
  • Head/neck procedure positioner
No Description
Orfit Industries NV
60119-U
In Commercial Distribution

  • 05420028772577 ()


  • Tone audiometer
AIO Lateral Fixation Set Couch 50cm - MRI compatible
Orfit Industries NV
33154
In Commercial Distribution

  • 05420028772508 ()


  • Radiological whole-body positioner
DUON Head ,Neck ,Shoulder Mask
Orfit Industries NV
60002/EFF32MA
In Commercial Distribution

  • 05420028772461 ()


  • Head/neck procedure positioner
2-pin Bar Set - iBeam® Couch Top 12 mm Base Plate - MRI compatible
Orfit Industries NV
33159
In Commercial Distribution

  • 05420028771600 ()


  • DNA-based tissue typing IVD, reagent
2pt Breast Mask - 4 push-pin profile in Efficast 2mm MAXI
Orfit Industries NV
35797/2MA/NP
In Commercial Distribution

  • 05420028771594 ()


  • Head/neck procedure positioner
2pt Breast Mask - 2 push-pin profile in Efficast 2.0 mm MAXI
Orfit Industries NV
33778/2MA/NP
In Commercial Distribution

  • 05420028771570 ()


  • Head/neck procedure positioner
Head mask
Orfit Industries NV
35776/2MI/MO
In Commercial Distribution

  • 05420028771471 ()


  • Head/neck procedure positioner
AIO Base Plate in CFL Hexapod
Orfit Industries NV
32301/HX
In Commercial Distribution

  • 05420028771228 ()


  • Radiological whole-body positioner
3pt Head Mask Nose Hole +Neck Flap
Orfit Industries NV
35779/32MA
In Commercial Distribution

  • 05420028771013 ()


  • Head/neck procedure positioner
3pt Head Mask - Nose Hole - Neck Flap in Efficast 2.0 mm MICRO
Orfit Industries NV
35768/2MI
In Commercial Distribution

  • 05420028770917 ()


  • Head/neck procedure positioner
Fixation Block for Aktina Couch 45cm wide - MRI compatible
Orfit Industries NV
32810
In Commercial Distribution

  • 05420028770818 ()


  • DNA-based tissue typing IVD, reagent
Silverman Head Support Index Base
Orfit Industries NV
CHS-1
In Commercial Distribution

  • 05420028770054 ()


  • Radiological whole-body positioner
Orfit Head Support Index Base
Orfit Industries NV
CHO-1
In Commercial Distribution

  • 05420028770023 ()


  • Radiological whole-body positioner
1 set of 4 Swivel Clamps for UON®/DUON® Base Plate
Orfit Industries NV
32097/9
In Commercial Distribution

  • 05420028769911 ()


  • DNA-based tissue typing IVD, reagent
Integra Universal Board for Head, Neck & Shoulders Immobilization
Orfit Industries NV
INT-3
In Commercial Distribution

  • 05420028769645 ()


  • Radiological whole-body positioner
Blue Gel Ring Head Holder
Orfit Industries NV
CHB-1
In Commercial Distribution

  • 05420028769591 ()


  • Radiological whole-body positioner
Sagittilt Prone Breast Solution
Orfit Industries NV
32070
In Commercial Distribution

  • 05420028769416 ()


  • DNA-based tissue typing IVD, reagent
Thermofit 23 x 30 cm
Orfit Industries NV
32391
In Commercial Distribution

  • 05420028769355 ()


  • Head/neck procedure positioner
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