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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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
Sagittilt® Sanitary Cover for Forehead Support package of 50 pcs.
Orfit Industries NV
32070/14
In Commercial Distribution

  • 05420028769287 ()


  • DNA-based tissue typing IVD, reagent
HNS Base Plate for push-pin Masks CFL
Orfit Industries NV
32148
In Commercial Distribution

  • 05420028769232 ()


  • DNA-based tissue typing IVD, reagent
2-pin Bar for Pin-point Couch 50cm wide - MRI compatible
Orfit Industries NV
32190
In Commercial Distribution

  • 05420028769065 ()


  • DNA-based tissue typing IVD, reagent
5pt Hybrid HNS Mask Large - No Nose Hole Eff 2MA - Nanor 12MI+ with push pins
Orfit Industries NV
33755/2MA/12MI+N/NH
In Commercial Distribution

  • 05420028768815 ()


  • Head/neck procedure positioner
5pt Hybrid HNS Mask Large - Nose Hole Eff 2MA - Nanor 12MI+ with push pins
Orfit Industries NV
33755/2MA/12MI+N
In Commercial Distribution

  • 05420028768679 ()


  • Head/neck procedure positioner
AIO Fix Set with 2-pin Bar Prodigy™ 53cm wide - MRI compatible
Orfit Industries NV
32185
In Commercial Distribution

  • 05420028768617 ()


  • Radiological whole-body positioner
AIO-IMRT Fix Set with 2-pin Bar Exact™ Couch Top - MRI compatible
Orfit Industries NV
32184
In Commercial Distribution

  • 05420028768600 ()


  • Radiological whole-body positioner
2-pin Bar Set - Exact™ Couch Top 12 mm Base Plate - MRI compatible
Orfit Industries NV
32183
In Commercial Distribution

  • 05420028768594 ()


  • DNA-based tissue typing IVD, reagent
2-pin Bar Set - Prodigy™ Couch 53cm 12mm Base Plate - MRI compatible
Orfit Industries NV
32182
In Commercial Distribution

  • 05420028768587 ()


  • DNA-based tissue typing IVD, reagent
Head mask
Orfit Industries NV
35779/2MA/NH
In Commercial Distribution

  • 05420028768457 ()


  • Head/neck procedure positioner
Head Base Plate for Cyberknife MRI compatible
Orfit Industries NV
32113MR
In Commercial Distribution

  • 05420028768198 ()


  • DNA-based tissue typing IVD, reagent
Head, Neck & Shoulders Base Plate for Cyberknife - MRI compatible
Orfit Industries NV
32117MR
In Commercial Distribution

  • 05420028768181 ()


  • DNA-based tissue typing IVD, reagent
Set of 6 RD Head Supports Extra Soft All Sizes
Orfit Industries NV
32433
In Commercial Distribution

  • 05420028768044 ()


  • DNA-based tissue typing IVD, reagent
3pt Head Mask Nose Hole +Neck Flap
Orfit Industries NV
35779/2MA/G
In Commercial Distribution

  • 05420028768037 ()


  • Head/neck procedure positioner
LOXON™ Set in plastic Long Base Plates - MRI compatible
Orfit Industries NV
32181
In Commercial Distribution

  • 05420028767894 ()


  • DNA-based tissue typing IVD, reagent
2-pin Bar Set (set of 2) Prodigy™ 53cm wide - MRI compatible
Orfit Industries NV
32179
In Commercial Distribution

  • 05420028767504 ()


  • DNA-based tissue typing IVD, reagent
2-pin Bar Set - Exact™ Couch Top Set of 2 - MRI compatible
Orfit Industries NV
32178
In Commercial Distribution

  • 05420028767498 ()


  • DNA-based tissue typing IVD, reagent
AIO Fix Set with 2-pin Bar Prodigy™ Couch 53cm wide
Orfit Industries NV
32174
In Commercial Distribution

  • 05420028767450 ()


  • Radiological whole-body positioner
AIO-IMRT Fix Set with 2-pin bar Exact™ Couch Top
Orfit Industries NV
32172
In Commercial Distribution

  • 05420028767443 ()


  • Radiological whole-body positioner
2-pin Bar Set - Exact™ Couch Top 12mm Base Plate
Orfit Industries NV
32171
In Commercial Distribution

  • 05420028767436 ()


  • DNA-based tissue typing IVD, reagent
2-pin Bar Set - Prodigy™ Couch 53cm 12mm Base Plate
Orfit Industries NV
32169
In Commercial Distribution

  • 05420028767382 ()


  • DNA-based tissue typing IVD, reagent
3PTS HEAD MASK SHORT
Orfit Industries NV
35775/2MI
In Commercial Distribution

  • 05420028766958 ()


  • Head/neck procedure positioner
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