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 Base Plate MR
Orfit Industries NV
32301/MR
In Commercial Distribution

  • 05420028708408 ()


  • Radiological whole-body positioner
TUR PACK
MEDLINE INDUSTRIES, INC.
DYNJ41213F
In Commercial Distribution

  • 10193489673340 ()
  • 40193489673341 ()
DYNJ41213F

  • General surgical procedure kit, non-medicated, single-use
PRE-OP SETUP KIT
MEDLINE INDUSTRIES, INC.
DYKS1026D
In Commercial Distribution

  • 10193489673333 ()
DYKS1026D

  • General surgical procedure kit, non-medicated, single-use
TOTAL HIP CDS
MEDLINE INDUSTRIES, INC.
CDS940963W
In Commercial Distribution

  • 10193489673289 ()
CDS940963W

  • General surgical procedure kit, non-medicated, single-use
5pt HNS Mask - Nose +Mouth Hole In Efficast 2.0 mm MAXI
Orfit Industries NV
33700/2MA/M
In Commercial Distribution

  • 05420028708309 ()


  • Head/neck procedure positioner
Wedge 9° angle in Fibreglass - MRI Compatible
Orfit Industries NV
35704/MR
In Commercial Distribution

  • 05420028708293 ()


  • DNA-based tissue typing IVD, reagent
5pt HNS Mask - Nose +Eye +Mouth hole In Efficast 2.0 mm MAXI
Orfit Industries NV
33700/2MA/EM
In Commercial Distribution

  • 05420028708262 ()


  • Head/neck procedure positioner
5pt HNS Mask - Nose Hole In Efficast 2.0 mm MAXI
Orfit Industries NV
33700/2MA
In Commercial Distribution

  • 05420028708255 ()


  • Head/neck procedure positioner
Block 20mm in Fibreglass - MRI Compatible
Orfit Industries NV
35703/MR
In Commercial Distribution

  • 05420028708231 ()


  • DNA-based tissue typing IVD, reagent
5pt HNS Mask - Nose +Mouth Hole In Efficast 1.6 mm MICRO
Orfit Industries NV
33700/16MI/M
In Commercial Distribution

  • 05420028708217 ()


  • Head/neck procedure positioner
5pt HNS Mask - Nose Hole In Efficast 1.6 mm MICRO
Orfit Industries NV
33700/16MI
In Commercial Distribution

  • 05420028708187 ()


  • Head/neck procedure positioner
Wedge 13.5° angle in Fibreglass - MRI Compatible
Orfit Industries NV
32424/MR
In Commercial Distribution

  • 05420028708170 ()


  • DNA-based tissue typing IVD, reagent
5pt Paediatric HNS Mask - Nose Hole Small - EFF 2mm Maxi
Orfit Industries NV
33691/2MA
In Commercial Distribution

  • 05420028708132 ()


  • Head/neck procedure positioner
3pt Paediatric Head Mask - Nose Hole Small, in Efficast 2.0 mm MAXI
Orfit Industries NV
33690/2MA
In Commercial Distribution

  • 05420028708101 ()


  • Head/neck procedure positioner
3pt Paediatric Head Mask - Nose Hole Medium -In Efficast 2.0 mm Maxi
Orfit Industries NV
33688/2MA
In Commercial Distribution

  • 05420028708064 ()


  • Head/neck procedure positioner
Bilateral Arm Support Board
Orfit Industries NV
CBA-1
In Commercial Distribution

  • 05420028707982 ()


  • Radiological whole-body positioner
Set of 3 LD Head supports without lateral neck flaps
Orfit Industries NV
32705
In Commercial Distribution

  • 05420028707944 ()


  • DNA-based tissue typing IVD, reagent
Set of 6 LD Head Supports All Sizes
Orfit Industries NV
32704
In Commercial Distribution

  • 05420028707920 ()


  • DNA-based tissue typing IVD, reagent
Set of 3 LD Head supports with Lateral Flaps
Orfit Industries NV
32703
In Commercial Distribution

  • 05420028707913 ()


  • DNA-based tissue typing IVD, reagent
Set of LD Blocks and Wedges 2 blocks 20/40mm + 2 wedges 9°/18°
Orfit Industries NV
32700
In Commercial Distribution

  • 05420028707876 ()


  • DNA-based tissue typing IVD, reagent
Thermofit 35 x 30 cm
Orfit Industries NV
32392
In Commercial Distribution

  • 05420028707647 ()


  • Head/neck procedure positioner
2-pin bar for Quantum couch 51.4 cm MR safe
Orfit Industries NV
33213
In Commercial Distribution

  • 05420028707630 ()


  • DNA-based tissue typing IVD, reagent
MammoRx Combination Pack No grid
Orfit Industries NV
CFB-005/EU/NG
In Commercial Distribution

  • 05420028707616 ()


  • Radiological whole-body positioner
MammoRx Bilateral Arm Support Board Configuration No Grid
Orfit Industries NV
CFB-004/EU/NG
In Commercial Distribution

  • 05420028707609 ()


  • Radiological whole-body positioner
MammoRx Bilateral Arm Configuration No Grid
Orfit Industries NV
CFB-003/EU/NG
In Commercial Distribution

  • 05420028707593 ()


  • Radiological whole-body positioner
MammoRx Breast board MRI compatible
Orfit Industries NV
CFB-001/MR
In Commercial Distribution

  • 05420028707586 ()


  • Radiological whole-body positioner
Prone Head Support Movable Chin Cushion
Orfit Industries NV
32380
In Commercial Distribution

  • 05420028707425 ()


  • DNA-based tissue typing IVD, reagent
Table Fix for PELVICAST™ Base Plate Set of 4
Orfit Industries NV
32160
In Commercial Distribution

  • 05420028706831 ()


  • DNA-based tissue typing IVD, reagent
AIO-IMRT Table Fix Set - AIO Fix Non-indexed Couch
Orfit Industries NV
32158
In Commercial Distribution

  • 05420028706817 ()


  • Radiological whole-body positioner
IMRT Bridge Bar Set (set of 2) iBeam® Couch Top - MRI compatible
Orfit Industries NV
32157
In Commercial Distribution

  • 05420028706800 ()


  • DNA-based tissue typing IVD, reagent
AIO LOXON™ Set - Exact™ Couch Top 2 pairs
Orfit Industries NV
32156
In Commercial Distribution

  • 05420028706794 ()


  • Radiological whole-body positioner
Pelvicast™ Loxon™ - Exact™ Couch Top 2 pairs
Orfit Industries NV
32155
In Commercial Distribution

  • 05420028706787 ()


  • DNA-based tissue typing IVD, reagent
2-pin Bar for Exact™ Couch
Orfit Industries NV
32154
In Commercial Distribution

  • 05420028706770 ()


  • DNA-based tissue typing IVD, reagent
Bridge Bar for iBeam® Couch MRI compatible
Orfit Industries NV
32151
In Commercial Distribution

  • 05420028706701 ()


  • DNA-based tissue typing IVD, reagent
Base Plate Extension
Orfit Industries NV
29105
In Commercial Distribution

  • 05420028706626 ()


  • DNA-based tissue typing IVD, reagent
PELVICAST™ Base Plate HPL
Orfit Industries NV
32123
In Commercial Distribution

  • 05420028706459 ()


  • DNA-based tissue typing IVD, reagent
PELVICAST™ Base Plate CFL
Orfit Industries NV
32122
In Commercial Distribution

  • 05420028706411 ()


  • DNA-based tissue typing IVD, reagent
Head Base Plate For Cyberknife - Polycarbonate
Orfit Industries NV
32113
In Commercial Distribution

  • 05420028706268 ()


  • DNA-based tissue typing IVD, reagent
HP Paediatric Base plate Head & shoulder in CFL Low density
Orfit Industries NV
32111
In Commercial Distribution

  • 05420028706220 ()


  • DNA-based tissue typing IVD, reagent
EVA Handle Set 13mm Light Blue Medium
Orfit Industries NV
32110/9
In Commercial Distribution

  • 05420028706206 ()


  • DNA-based tissue typing IVD, reagent
EVA Block Set 13 mm Light Blue Small - set of 2 pcs.
Orfit Industries NV
32110/8
In Commercial Distribution

  • 05420028706190 ()


  • DNA-based tissue typing IVD, reagent
EVA Handle Set 13mm Dark Blue Large - 24 cm - 4Pc/Set
Orfit Industries NV
32110/7
In Commercial Distribution

  • 05420028706183 ()


  • DNA-based tissue typing IVD, reagent
UON® Base Plate for Head High Density - Acrylic
Orfit Industries NV
32097
In Commercial Distribution

  • 05420028705902 ()


  • DNA-based tissue typing IVD, reagent
ENDO KIT
MEDLINE INDUSTRIES, INC.
DYKE1653
In Commercial Distribution

  • 40193489673037 ()
  • 10193489673036 ()
DYKE1653

  • General surgical procedure kit, non-medicated, single-use
SC HYSTEROSCOPY
MEDLINE INDUSTRIES, INC.
DYNJ57638A
In Commercial Distribution

  • 10193489673029 ()
DYNJ57638A

  • General surgical procedure kit, non-medicated, single-use
SC D AND C PACK
MEDLINE INDUSTRIES, INC.
DYNJ49990F
In Commercial Distribution

  • 10193489673012 ()
DYNJ49990F

  • General surgical procedure kit, non-medicated, single-use
SC CYSTO
MEDLINE INDUSTRIES, INC.
DYNJ49989D
In Commercial Distribution

  • 10193489673005 ()
DYNJ49989D

  • General surgical procedure kit, non-medicated, single-use
SC CRANI PACK
MEDLINE INDUSTRIES, INC.
DYNJ49988C
In Commercial Distribution

  • 10193489672992 ()
DYNJ49988C

  • General surgical procedure kit, non-medicated, single-use
SC HEART CATH PACK
MEDLINE INDUSTRIES, INC.
DYNJ54298B
In Commercial Distribution

  • 10193489672985 ()
DYNJ54298B

  • General surgical procedure kit, non-medicated, single-use
HAND CDS
MEDLINE INDUSTRIES, INC.
CDS941429I
In Commercial Distribution

  • 10193489672930 ()
  • 40193489672931 ()
CDS941429I

  • General surgical procedure kit, non-medicated, single-use
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