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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4pt HNS Mask - Nose Hole in Efficast 2.0 mm MAXI
Orfit Industries NV
35764/2MA
In Commercial Distribution

  • 05420028716342 ()


  • Head/neck procedure positioner
PLASTIC MAJOR
MEDLINE INDUSTRIES, INC.
DYNJ904979A
In Commercial Distribution

  • 10193489674903 ()
DYNJ904979A

  • General surgical procedure kit, non-medicated, single-use
AIO 3.0 Lateral fixation device non-indexed 500mm (set of 2 pcs.) - MRI Compatible
Orfit Industries NV
38207
In Commercial Distribution

  • 05420028716168 ()


  • Radiological whole-body positioner
BiteFix with tongue depressor (blue lid)
Orfit Industries NV
32789
In Commercial Distribution

  • 05420028716007 ()


  • DNA-based tissue typing IVD, reagent
DOUBLE
MEDLINE INDUSTRIES, INC.
DYKE1444A
In Commercial Distribution

  • 10193489674774 ()
DYKE1444A

  • General surgical procedure kit, non-medicated, single-use
BiteFix without tongue depressor (green lid)
Orfit Industries NV
32788
In Commercial Distribution

  • 05420028715987 ()


  • DNA-based tissue typing IVD, reagent
OPEN HEART ADULT
MEDLINE INDUSTRIES, INC.
CDS840396T
In Commercial Distribution

  • 10193489674736 ()
CDS840396T

  • General surgical procedure kit, medicated
3pt Head Mask - Nose + Eye + Mouth Hole in Efficast 2.0 mm Maxi
Orfit Industries NV
35763/2MA/EM
In Commercial Distribution

  • 05420028715918 ()


  • Head/neck procedure positioner
3 pt Head Mask - Nose Hole in Efficast 2.0 mm Maxi
Orfit Industries NV
35763/2MA
In Commercial Distribution

  • 05420028715901 ()


  • Head/neck procedure positioner
3pt Head Mask - No Nose Hole in Efficast 1.6 mm Micro
Orfit Industries NV
35763/16MI/NH
In Commercial Distribution

  • 05420028715864 ()


  • Head/neck procedure positioner
3pt Head Mask - Nose + Eye + Mouth hole in Efficast 1.6 mm Micro
Orfit Industries NV
35763/16MI/EM
In Commercial Distribution

  • 05420028715802 ()


  • Head/neck procedure positioner
3pt Head Mask - Nose Hole in Efficast 1.6 mm Micro
Orfit Industries NV
35763/16MI
In Commercial Distribution

  • 05420028715796 ()


  • Head/neck procedure positioner
Push pin unlock tool
Orfit Industries NV
32199
In Commercial Distribution

  • 05420028715598 ()


  • DNA-based tissue typing IVD, reagent
3pt Head Mask - Nose Hole Extra Cranial Flaps EFF 2.0 mm MAXI
Orfit Industries NV
35760/EFF2MA
In Commercial Distribution

  • 05420028715451 ()


  • Head/neck procedure positioner
3pt Head Mask - Nose Hole Extra Cranial Flaps EFF 1.6 mm Micro
Orfit Industries NV
35760/EFF16MI
In Commercial Distribution

  • 05420028715369 ()


  • Head/neck procedure positioner
5pt Paediatric Mask for HP PRO Solution - Small Nanor 2.0 mm Micro+, No Nose Hole
Orfit Industries NV
25107/2MI+N/NH
In Commercial Distribution

  • 05420028715345 ()


  • Radiological whole-body positioner
3pt Paediatric Mask for HP PRO Solution - Small Nanor 1.6 mm Micro+, No Nose Hole
Orfit Industries NV
25103/16MI+N/NH
In Commercial Distribution

  • 05420028715338 ()


  • Radiological whole-body positioner
Set of HD Blocks and Wedges 2 blocks 20/40mm + 2 wedges 9°/18°
Orfit Industries NV
35754/8
In Commercial Distribution

  • 05420028715123 ()


  • DNA-based tissue typing IVD, reagent
Secondary Base Plate HPL
Orfit Industries NV
35754/6N
In Commercial Distribution

  • 05420028715055 ()


  • DNA-based tissue typing IVD, reagent
HP Head, Neck & Shoulders Base Plate in HPL High Density
Orfit Industries NV
35751N
In Commercial Distribution

  • 05420028714881 ()


  • DNA-based tissue typing IVD, reagent
Caudal Adapter Plate for 2-pin Bar 30 mm Base Plate
Orfit Industries NV
35747/4
In Commercial Distribution

  • 05420028714782 ()


  • DNA-based tissue typing IVD, reagent
Adapter Plate for Table Fix 12 mm Base Plate (with screws)
Orfit Industries NV
35747
In Commercial Distribution

  • 05420028714737 ()


  • DNA-based tissue typing IVD, reagent
HAND PACK-LF
MEDLINE INDUSTRIES, INC.
DYNJ62628
In Commercial Distribution

  • 10193489674576 ()
DYNJ62628

  • General surgical procedure kit, non-medicated, single-use
2pt Breast Supine Mask Large in Efficast 3.2mm MAXI
Orfit Industries NV
35728/32MA
In Commercial Distribution

  • 05420028714041 ()


  • Head/neck procedure positioner
2pt Breast Supine Mask Medium in Efficast 3.2 mm MAXI
Orfit Industries NV
35727/32MA
In Commercial Distribution

  • 05420028714027 ()


  • Head/neck procedure positioner
CUSTOM LABELS STEREO BOX
MEDLINE INDUSTRIES, INC.
LBL0001251
In Commercial Distribution

  • 40193489674539 ()
  • 10193489674538 ()
LBL0001251

  • General surgical procedure kit, non-medicated, single-use
ALT LOWER EXTREMITY CDS
MEDLINE INDUSTRIES, INC.
CDS983899G
In Commercial Distribution

  • 10193489674521 ()
CDS983899G

  • General surgical procedure kit, non-medicated, single-use
6pt Pelvic Mask - Small Prone + Supine in Efficast 3.2 mm MAXI
Orfit Industries NV
35710/32MA
In Commercial Distribution

  • 05420028713617 ()


  • Head/neck procedure positioner
Shim 2mm Head Acrylic Rev A
Orfit Industries NV
35702/2
In Commercial Distribution

  • 05420028713563 ()


  • DNA-based tissue typing IVD, reagent
CHP TRANSPLANT BACK TABLE PACK
MEDLINE INDUSTRIES, INC.
DYNJ36622G
In Commercial Distribution

  • 10193489674507 ()
  • 40193489674508 ()
DYNJ36622G

  • General surgical procedure kit, non-medicated, single-use
CHS WOUND CARE KIT
MEDLINE INDUSTRIES, INC.
DYKM1826
In Commercial Distribution

  • 10193489674484 ()
  • 40193489674485 ()
DYKM1826

  • General surgical procedure kit, non-medicated, single-use
LAP CHOLE PACK
MEDLINE INDUSTRIES, INC.
DYNJ55074C
In Commercial Distribution

  • 10193489674446 ()
  • 40193489674447 ()
DYNJ55074C

  • General surgical procedure kit, non-medicated, single-use
Bellyboard Full Insert
Orfit Industries NV
29023-V2
In Commercial Distribution

  • 05420028713228 ()


  • DNA-based tissue typing IVD, reagent
HP PRO – PED - Head Support Indexing Plate - 0-7y set of 20 pcs of 25000/39
Orfit Industries NV
25000/39/20
In Commercial Distribution

  • 05420028713198 ()


  • Radiological whole-body positioner
HP PRO Adult CT Overlay for Aerial Couch Rev B
Orfit Industries NV
25000/43
In Commercial Distribution

  • 05420028713143 ()


  • Radiological whole-body positioner
Vacuum bag 700 x 1000mm / 30 liter
Orfit Industries NV
18212
In Commercial Distribution

  • 05420028713082 ()


  • Radiological whole-body positioner
Bellyboard - Belly and Pelvic Right Lateral Support
Orfit Industries NV
29022-V2
In Commercial Distribution

  • 05420028712955 ()


  • DNA-based tissue typing IVD, reagent
Bellyboard - Belly and Pelvic Left Lateral Support
Orfit Industries NV
29021-V2
In Commercial Distribution

  • 05420028712887 ()


  • DNA-based tissue typing IVD, reagent
Bellyboard - Belly and Pelvic Cushion
Orfit Industries NV
29020-V2
In Commercial Distribution

  • 05420028712801 ()


  • DNA-based tissue typing IVD, reagent
Breast+Lungboard - Thorax-Abdomen Arm Rest - Low
Orfit Industries NV
29019-V2
In Commercial Distribution

  • 05420028712757 ()


  • DNA-based tissue typing IVD, reagent
Breast+Lungboard - Thorax-Abdomen Arm Rest - High
Orfit Industries NV
29018-V2
In Commercial Distribution

  • 05420028712740 ()


  • DNA-based tissue typing IVD, reagent
HP PRO extension for Aerial Couch - Adult
Orfit Industries NV
25000/34
In Commercial Distribution

  • 05420028712719 ()


  • Radiological whole-body positioner
Breast+Lungboard - Thorax-Abdomen Left Lateral Support 15°
Orfit Industries NV
29017-V2
In Commercial Distribution

  • 05420028712436 ()


  • DNA-based tissue typing IVD, reagent
Breast+Lungboard - Thorax-Abdomen Right Lateral Support 15°
Orfit Industries NV
29016-V2
In Commercial Distribution

  • 05420028712085 ()


  • DNA-based tissue typing IVD, reagent
Breast+Lungboard - Thorax-Abdomen Left Lateral Support 10°
Orfit Industries NV
29015-V2
In Commercial Distribution

  • 05420028712078 ()


  • DNA-based tissue typing IVD, reagent
Breast+Lungboard - Thorax-Abdomen Right Lateral Support 10°
Orfit Industries NV
29014-V2
In Commercial Distribution

  • 05420028712061 ()


  • DNA-based tissue typing IVD, reagent
Breast+Lungboard - Thorax-Abdomen Left Lateral Support 5°
Orfit Industries NV
29013-V2
In Commercial Distribution

  • 05420028712054 ()


  • DNA-based tissue typing IVD, reagent
Breast + Lungboard - Thorax-Abdomen Right Lateral Support 5°
Orfit Industries NV
29012-V2
In Commercial Distribution

  • 05420028712047 ()


  • DNA-based tissue typing IVD, reagent
1 Pc Breast +Lungboard - Thorax-Abdomen Lateral Support 0°
Orfit Industries NV
29011-V2
In Commercial Distribution

  • 05420028712030 ()


  • DNA-based tissue typing IVD, reagent
C SECTION PACK-LF
MEDLINE INDUSTRIES, INC.
DYNJ52387G
In Commercial Distribution

  • 10193489673708 ()
DYNJ52387G

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