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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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
Orfit® Extremities Solution
Orfit Industries NV
32103
In Commercial Distribution

  • 05420028766569 ()


  • DNA-based tissue typing IVD, reagent
Shim 2mm HNS Acrylic
Orfit Industries NV
35702/4
In Commercial Distribution

  • 05420028766521 ()


  • DNA-based tissue typing IVD, reagent
AIO Fix Set - Prodigy™ Couch 53cm wide - MRI compatible
Orfit Industries NV
32173
In Commercial Distribution

  • 05420028766293 ()


  • Radiological whole-body positioner
LOXON™ Set of 2 pcs for HP Head & Neck Base Plates MRI compatible
Orfit Industries NV
33168
In Commercial Distribution

  • 05420028766217 ()


  • DNA-based tissue typing IVD, reagent
3pt Head Mask - Nose Hole - Neck Flap in Efficast 2.0 mm Maxi, No Profiles
Orfit Industries NV
35768/2MA/NP
In Commercial Distribution

  • 05420028765470 ()


  • Head/neck procedure positioner
AIO Lateral Fixation Device 53cm wide - MRI compatible
Orfit Industries NV
32817
In Commercial Distribution

  • 05420028764848 ()


  • Radiological whole-body positioner
AIO Lateral Fixation Device 52cm wide - MRI compatible
Orfit Industries NV
32816
In Commercial Distribution

  • 05420028764671 ()


  • Radiological whole-body positioner
Head mask
Orfit Industries NV
35776/2MI/NP
In Commercial Distribution

  • 05420028764626 ()


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

  • 05420028764619 ()


  • Head/neck procedure positioner
AIO Lateral Fixation Device 51cm wide - MRI compatible
Orfit Industries NV
32815
In Commercial Distribution

  • 05420028764602 ()


  • Radiological whole-body positioner
AIO Lateral Fixation Device 50cm wide - MRI compatible
Orfit Industries NV
32814
In Commercial Distribution

  • 05420028764596 ()


  • Radiological whole-body positioner
Anti-tilt iBeam® Couch Fixation Long Base Plates - MRI compatible
Orfit Industries NV
32813
In Commercial Distribution

  • 05420028764589 ()


  • DNA-based tissue typing IVD, reagent
2-pin Bar for Non-indexed Couch 50cm wide
Orfit Industries NV
33119
In Commercial Distribution

  • 05420028764558 ()


  • DNA-based tissue typing IVD, reagent
2-pin Bar for Prodigy™ Couch couch width 50 cm - MR safe
Orfit Industries NV
32197
In Commercial Distribution

  • 05420028764466 ()


  • DNA-based tissue typing IVD, reagent
3pt Head Mask - Nose Hole - Neck Flap Extra Cranial Flaps - in Efficast 1.6 mm MICRO
Orfit Industries NV
35776/16MI
In Commercial Distribution

  • 05420028764176 ()


  • Head/neck procedure positioner
Caudal Adapter Plate for 2-pin Bar 30 mm Base Plate - MRI compatible
Orfit Industries NV
35747/8
In Commercial Distribution

  • 05420028764039 ()


  • DNA-based tissue typing IVD, reagent
Fixation block for MRI Head & Neck base plate for Philips couch
Orfit Industries NV
32196
In Commercial Distribution

  • 05420028764015 ()


  • DNA-based tissue typing IVD, reagent
Arm Strap
Orfit Industries NV
32107
In Commercial Distribution

  • 05420028763773 ()


  • DNA-based tissue typing IVD, reagent
HP Long base plate CFL-IMRT-H & N + Shoulders+Extra Paeditric slots
Orfit Industries NV
32150-PED
In Commercial Distribution

  • 05420028763674 ()


  • DNA-based tissue typing IVD, reagent
RD Head Support - Model 2 Without Lateral Neck Flaps - Other Hardware
Orfit Industries NV
32423ZF-MD
In Commercial Distribution

  • 05420028763551 ()


  • DNA-based tissue typing IVD, reagent
RD Head Support - Model 1 With Lateral Neck Flaps - Other Hardware
Orfit Industries NV
32423-MD
In Commercial Distribution

  • 05420028763544 ()


  • DNA-based tissue typing IVD, reagent
RD Head Support - Model 6 Without Lateral Neck Flaps - Other Hardware
Orfit Industries NV
32422ZF-MD
In Commercial Distribution

  • 05420028763537 ()


  • DNA-based tissue typing IVD, reagent
RD Head Support - Model 5 With Lateral Neck Flaps - Other Hardware
Orfit Industries NV
32422-MD
In Commercial Distribution

  • 05420028763520 ()


  • DNA-based tissue typing IVD, reagent
RD Head Support - Model 4 Without Lateral Neck Flaps - Other Hardware
Orfit Industries NV
32421ZF-MD
In Commercial Distribution

  • 05420028763513 ()


  • DNA-based tissue typing IVD, reagent
RD Head Support - Model 3 With Lateral Neck Flaps - Other Hardware
Orfit Industries NV
32421-MD
In Commercial Distribution

  • 05420028763506 ()


  • DNA-based tissue typing IVD, reagent
RD Head Supports for Other Hardware Set of 6 Models
Orfit Industries NV
32708-MD
In Commercial Distribution

  • 05420028763490 ()


  • DNA-based tissue typing IVD, reagent
Head Support Interface for S-shaped Base Plate (CFL)
Orfit Industries NV
32047-CFL
In Commercial Distribution

  • 05420028763483 ()


  • Radiological whole-body positioner
HP Adapter for S-Type Base Plates with Medium Density Center Plate
Orfit Industries NV
32106
In Commercial Distribution

  • 05420028763278 ()


  • DNA-based tissue typing IVD, reagent
Thermoplastic Mask Head ( 10 PCS) 10PC of 3 pt Hybrid Head Mask (P10106-300)
Orfit Industries NV
45214-BOX10
In Commercial Distribution

  • 05420028763230 ()


  • Head/neck procedure positioner
Thermoplastic Mask Nose (10 PCS) P10106-301 10Pc of 3 pt HYBRID HEAD Nose Mask
Orfit Industries NV
45213-BOX10
In Commercial Distribution

  • 05420028763223 ()


  • Head/neck procedure positioner
AIO Indexable Knee Frame Short
Orfit Industries NV
29053
In Commercial Distribution

  • 05420028763087 ()


  • Radiological whole-body positioner
Set of LD Blocks and Wedges 2 blocks 20/40mm + 2 wedges 9°/13.5°
Orfit Industries NV
32709
In Commercial Distribution

  • 05420028762592 ()


  • DNA-based tissue typing IVD, reagent
2-pin Bar for Exact™ Couch MRI compatible
Orfit Industries NV
32166
In Commercial Distribution

  • 05420028761816 ()


  • DNA-based tissue typing IVD, reagent
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