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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Efficast® 45 x 60 cm x 2.0 mm Micro Perforation
Orfit Industries NV
8333Y.2/R
In Commercial Distribution

  • 05420028729847 ()


  • Radiological whole-body positioner
5pt Open Face Mask for HP PRO Solution Nanor 2.4 mm Micro+
Orfit Industries NV
25116/24MI+N
In Commercial Distribution

  • 05420028729687 ()


  • Radiological whole-body positioner
5pt Mask for HP PRO Solution Nanor 2.4 mm Micro+
Orfit Industries NV
25115/24MI+N
In Commercial Distribution

  • 05420028729670 ()


  • Radiological whole-body positioner
3pt Open Face Mask for HP PRO Solution Nanor 2.4 mm Micro+
Orfit Industries NV
25114/24MI+N
In Commercial Distribution

  • 05420028729656 ()


  • Radiological whole-body positioner
3pt Mask for HP PRO Solution Nanor 2.4 mm Micro+
Orfit Industries NV
25113/24MI+N
In Commercial Distribution

  • 05420028729649 ()


  • Radiological whole-body positioner
SBRT Long Base Plate Hexapod Compatible - H&N & Thorax & Abdomen
Orfit Industries NV
32317/1/HX/2
In Commercial Distribution

  • 05420028729595 ()


  • Radiological whole-body positioner
45 x 60 cm, ORFIT® 2mm Maxi Natural
Orfit Industries NV
8333N.SO3/R
In Commercial Distribution

  • 05420028729458 ()


  • Radiological whole-body positioner
Bolus Sheet White 45 cm x 60 cm x 2 mm - No Perfo
Orfit Industries NV
8333N.SO1/R
In Commercial Distribution

  • 05420028729427 ()


  • Radiological whole-body positioner
AIO 3.0 - Cabinet
Orfit Industries NV
38215
In Commercial Distribution

  • 05420028729397 ()


  • Radiological whole-body positioner
HP PRO CT overlay - Aerial couch compatible Paediatric 0-7 y
Orfit Industries NV
25000/63
In Commercial Distribution

  • 05420028729359 ()


  • Radiological whole-body positioner
HP PRO extension for Aerial couch Paediatric 0-7 y
Orfit Industries NV
25000/62
In Commercial Distribution

  • 05420028729311 ()


  • Radiological whole-body positioner
AIO Base Plate in CFL Hexapod - Paediatric version
Orfit Industries NV
32301/HX/PEDP
In Commercial Distribution

  • 05420028729281 ()


  • Radiological whole-body positioner
3pt Hybrid Head Open Face Mask for BiteFix Eff 16MI - Nanor 12MI+
Orfit Industries NV
33796/16MI/12MI+N
In Commercial Distribution

  • 05420028729250 ()


  • Head/neck procedure positioner
AIO 3.0 - Set of 6 pins for 0 degree cushion
Orfit Industries NV
38211/6
In Commercial Distribution

  • 05420028729236 ()


  • Head/neck procedure positioner
AIO Paediatric Base Plate - MRI compatible
Orfit Industries NV
32301-PED/MR
In Commercial Distribution

  • 05420028729229 ()


  • Radiological whole-body positioner
AIO Base Plate in CFL version Hexapod Base plate only
Orfit Industries NV
32301/HXP
In Commercial Distribution

  • 05420028729151 ()


  • Radiological whole-body positioner
5pt Single Layer HP Head, Neck & Shoulders Mask - Paediatric - Medium Size
Orfit Industries NV
33794/2MA
In Commercial Distribution

  • 05420028728994 ()


  • Head/neck procedure positioner
Rectangular Extension for Aerial Couch (Long)
Orfit Industries NV
25000/38
In Commercial Distribution

  • 05420028728680 ()


  • Radiological whole-body positioner
Bolus Sheet Beige, no powder 45 cm x 60 cm x 2 mm - No Perfo
Orfit Industries NV
8333.SO1/R
In Commercial Distribution

  • 05420028728635 ()


  • Radiological whole-body positioner
Efficast® 45 x 60 cm x 1.6 mm Micro Perforation
Orfit Industries NV
8332Y.2/R
In Commercial Distribution

  • 05420028728499 ()


  • Radiological whole-body positioner
Bolus Sheet White 22.5 cm x 20 cm x 2 mm - No Perfo
Orfit Industries NV
8313N.SO1/R
In Commercial Distribution

  • 05420028727904 ()


  • Radiological whole-body positioner
2-pin Bar for Pin-point Couch 53cm wide - MRI compatible
Orfit Industries NV
33219
In Commercial Distribution

  • 05420028727591 ()


  • DNA-based tissue typing IVD, reagent
Allfit™ 6 bags of 500 gr/bag
Orfit Industries NV
703011
In Commercial Distribution

  • 05420028725771 ()


  • Radiological whole-body positioner
3pt Hybrid Head mask for BiteFix - No Nose hole Eff 2MA - Nanor 12MI+ with push pins
Orfit Industries NV
33793/2MA/12MI+N/NH
In Commercial Distribution

  • 05420028725597 ()


  • Head/neck procedure positioner
5pt Hybrid HNS mask - No Nose Hole Eff 2MA - Nanor 12MI+ with push pins
Orfit Industries NV
33739/2MA/12MI+N/NH
In Commercial Distribution

  • 05420028725580 ()


  • Head/neck procedure positioner
Duon® Head Mask - Neck Flap
Orfit Industries NV
60123
In Commercial Distribution

  • 05420028725559 ()


  • Head/neck procedure positioner
Duon® Head Mask - Neck Flap
Orfit Industries NV
60122
In Commercial Distribution

  • 05420028725528 ()


  • Head/neck procedure positioner
Duon® Head Mask
Orfit Industries NV
60120
In Commercial Distribution

  • 05420028725481 ()


  • Head/neck procedure positioner
UON® Head Mask -Neck Flap
Orfit Industries NV
60117
In Commercial Distribution

  • 05420028725450 ()


  • Head/neck procedure positioner
Uon® Head Mask
Orfit Industries NV
60112
In Commercial Distribution

  • 05420028725412 ()


  • Head/neck procedure positioner
Uon® Head Mask
Orfit Industries NV
60110
In Commercial Distribution

  • 05420028725382 ()


  • Head/neck procedure positioner
Rectangular Extension for Aerial Couch (Short)
Orfit Industries NV
25000/53
In Commercial Distribution

  • 05420028725375 ()


  • Radiological whole-body positioner
ANESTHESIA CIRCUIT-LF
MEDLINE INDUSTRIES, INC.
DYNJAA10653A
In Commercial Distribution

  • 10193489675597 ()
  • 40193489675598 ()
DYNJAA10653A

  • General surgical procedure kit, non-medicated, single-use
UON® Head Mask
Orfit Industries NV
60095
In Commercial Distribution

  • 05420028725313 ()


  • Head/neck procedure positioner
MAJOR EXTREMITY
MEDLINE INDUSTRIES, INC.
DYNJ44668F
In Commercial Distribution

  • 10193489675566 ()
DYNJ44668F

  • General surgical procedure kit, non-medicated, single-use
AIO 3.0 - Base Plate CFL for Varian Halcyon and Ethos systems
Orfit Industries NV
38009
In Commercial Distribution

  • 05420028723463 ()


  • Radiological whole-body positioner
AIO 3.0 - Loxon Set for Halcyon and Ethos systems
Orfit Industries NV
38212
In Commercial Distribution

  • 05420028723449 ()


  • Radiological whole-body positioner
AIO 3.0 - Base plate CFL - Without leg separator Hexapod compatible
Orfit Industries NV
38008
In Commercial Distribution

  • 05420028723401 ()


  • Radiological whole-body positioner
RR-D/E PACK
MEDLINE INDUSTRIES, INC.
DYNJ62645
In Commercial Distribution

  • 10193489675528 ()
DYNJ62645

  • General surgical procedure kit, non-medicated, single-use
CUSTOM VASCULAR ANGIO
MEDLINE INDUSTRIES, INC.
DYNJ62641
In Commercial Distribution

  • 10193489675511 ()
  • 40193489675512 ()
DYNJ62641

  • General surgical procedure kit, non-medicated, single-use
TOTAL KNEE PACK-LF
MEDLINE INDUSTRIES, INC.
DYNJ51460B
In Commercial Distribution

  • 10193489675504 ()
DYNJ51460B

  • General surgical procedure kit, non-medicated, single-use
BASIC SET UP PACK
MEDLINE INDUSTRIES, INC.
DYNJ52618A
In Commercial Distribution

  • 10193489675412 ()
DYNJ52618A

  • General surgical procedure kit, non-medicated, single-use
iBeam evo Extension Basic Module Orfit HP Head
Orfit Industries NV
32132
In Commercial Distribution

  • 05420028721582 ()


  • DNA-based tissue typing IVD, reagent
ACH ORTHO EXTREMITY PACK
MEDLINE INDUSTRIES, INC.
DYNJ51163F
In Commercial Distribution

  • 10193489675399 ()
DYNJ51163F

  • General surgical procedure kit, non-medicated, single-use
LITHOTOMY HYSTEROSCOPY D&C CDS
MEDLINE INDUSTRIES, INC.
CDS985427D
In Commercial Distribution

  • 10193489675382 ()
CDS985427D

  • General surgical procedure kit, non-medicated, single-use
KNEE ARTHROSCOPY CDS
MEDLINE INDUSTRIES, INC.
CDS985425G
In Commercial Distribution

  • 10193489675375 ()
CDS985425G

  • General surgical procedure kit, non-medicated, single-use
SPINE-ROH
MEDLINE INDUSTRIES, INC.
DYNJ903293I
In Commercial Distribution

  • 10193489675368 ()
DYNJ903293I

  • General surgical procedure kit, non-medicated, single-use
CV MINOR PACK
MEDLINE INDUSTRIES, INC.
DYNJ57044F
In Commercial Distribution

  • 10193489675313 ()
DYNJ57044F

  • General surgical procedure kit, non-medicated, single-use
CV PROCEDURE
MEDLINE INDUSTRIES, INC.
DYNJC9161D
In Commercial Distribution

  • 10193489675306 ()
DYNJC9161D

  • General surgical procedure kit, non-medicated, single-use
CRMC ROBOTIC GYN
MEDLINE INDUSTRIES, INC.
DYNJ61112A
In Commercial Distribution

  • 10193489675283 ()
DYNJ61112A

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