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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DUON® Hybrid Open Face Mask - H. & N. & Shoulders U-Plast 2.4mm Maxi/Nanor 1.2mm micro+
Orfit Industries NV
60009
In Commercial Distribution

  • 05420028719947 ()


  • Head/neck procedure positioner
AIO Lateral Fixation Set - Table Fix Couch 53cm
Orfit Industries NV
33136
In Commercial Distribution

  • 05420028718599 ()


  • Radiological whole-body positioner
AIO Lateral Fixation Set - Table Fix Couch 51cm
Orfit Industries NV
33144
In Commercial Distribution

  • 05420028718353 ()


  • Radiological whole-body positioner
5pt H&N&S Mask -Nose Hole
Orfit Industries NV
35791/2MI/NP
In Commercial Distribution

  • 05420028718322 ()


  • Head/neck procedure positioner
5pt H&N&S Mask - Nose Hole
Orfit Industries NV
35791/2MI
In Commercial Distribution

  • 05420028718315 ()


  • Head/neck procedure positioner
5pt H&N&S Mask -No Nose Hole
Orfit Industries NV
35791/2MA/NH
In Commercial Distribution

  • 05420028718285 ()


  • Head/neck procedure positioner
5pt H&N&S Mask -Nose Hole
Orfit Industries NV
35791/2MA
In Commercial Distribution

  • 05420028718278 ()


  • Head/neck procedure positioner
5pts HNS Mask - Nose Hole
Orfit Industries NV
35791/16MI/NP
In Commercial Distribution

  • 05420028718247 ()


  • Head/neck procedure positioner
5pt H&N&S Mask -Nose Hole
Orfit Industries NV
35791/16MI
In Commercial Distribution

  • 05420028718216 ()


  • Head/neck procedure positioner
AIO 3.0 Lateral fixation device non-indexed 465mm (set of 2 pcs.) - MRI Compatible
Orfit Industries NV
38208
In Commercial Distribution

  • 05420028718193 ()


  • Radiological whole-body positioner
2Pts Breast Mask Supine
Orfit Industries NV
35790/32MA
In Commercial Distribution

  • 05420028718124 ()


  • Head/neck procedure positioner
2pts Breast Mask, Supine
Orfit Industries NV
35790/2MA
In Commercial Distribution

  • 05420028718087 ()


  • Head/neck procedure positioner
4Pt Pelvic Mask SMALL Supine+Prone
Orfit Industries NV
35788/32MA
In Commercial Distribution

  • 05420028718018 ()


  • Head/neck procedure positioner
Pelvic Mask Medium
Orfit Industries NV
35787/32MA
In Commercial Distribution

  • 05420028717981 ()


  • Head/neck procedure positioner
4pt Pelvic Mask Medium Supine+Prone
Orfit Industries NV
35787/32
In Commercial Distribution

  • 05420028717974 ()


  • Head/neck procedure positioner
4pt Pelvic Mask LARGE Prone+Supine
Orfit Industries NV
35784/32MA
In Commercial Distribution

  • 05420028717875 ()


  • Head/neck procedure positioner
5pt H&N&S Mask - Nose +Eye Hole
Orfit Industries NV
35791/2MI/G17
In Commercial Distribution

  • 05420028717844 ()


  • Head/neck procedure positioner
Central Panel in HPL
Orfit Industries NV
35781-N1/2
In Commercial Distribution

  • 05420028717660 ()


  • DNA-based tissue typing IVD, reagent
PELVICAST WIDE SIZED BASE
Orfit Industries NV
35781-N1
In Commercial Distribution

  • 05420028717639 ()


  • DNA-based tissue typing IVD, reagent
6pt Pelvic Mask LARGE Supine
Orfit Industries NV
35780/32MA
In Commercial Distribution

  • 05420028717592 ()


  • Head/neck procedure positioner
3pt Head Mask Nose Hole +Neck Flap
Orfit Industries NV
35779/2MI
In Commercial Distribution

  • 05420028717547 ()


  • Head/neck procedure positioner
AIO 3.0 accessories: set of 2 x 38203 Loxon set for Exact couch
Orfit Industries NV
38209
In Commercial Distribution

  • 05420028717493 ()


  • Radiological whole-body positioner
Head Mask
Orfit Industries NV
35779/2MA/M
In Commercial Distribution

  • 05420028717479 ()


  • Head/neck procedure positioner
Head Mask
Orfit Industries NV
35779/2MA/EM
In Commercial Distribution

  • 05420028717455 ()


  • Head/neck procedure positioner
3pt Head Mask Nose Hole +Neck Flap
Orfit Industries NV
35779/2MA
In Commercial Distribution

  • 05420028717424 ()


  • Head/neck procedure positioner
MINOR LITHOTOMY PACK
MEDLINE INDUSTRIES, INC.
DYNJ62638
In Commercial Distribution

  • 10193489675191 ()
  • 40193489675192 ()
DYNJ62638

  • General surgical procedure kit, non-medicated, single-use
Head mask
Orfit Industries NV
35779/16MI/M
In Commercial Distribution

  • 05420028717394 ()


  • Head/neck procedure positioner
C SECTION PACK
MEDLINE INDUSTRIES, INC.
DYNJ44355F
In Commercial Distribution

  • 10193489675177 ()
  • 40193489675178 ()
DYNJ44355F

  • General surgical procedure kit, non-medicated, single-use
Head mask
Orfit Industries NV
35779/16MI
In Commercial Distribution

  • 05420028717363 ()


  • Head/neck procedure positioner
SPINE PACK
MEDLINE INDUSTRIES, INC.
DYNJ55281D
In Commercial Distribution

  • 40193489675147 ()
  • 10193489675146 ()
DYNJ55281D

  • General surgical procedure kit, non-medicated, single-use
5pt Mask for HP PRO Solution Large - No Nose Hole Nanor 2.0 mm Micro+
Orfit Industries NV
25108/2MI+N/NH
In Commercial Distribution

  • 05420028717349 ()


  • Radiological whole-body positioner
CUSTOM ANGIO KIT
MEDLINE INDUSTRIES, INC.
SAMPC0588
In Commercial Distribution

  • 10193489675122 ()
SAMPC0588

  • General surgical procedure kit, non-medicated, single-use
Head mask
Orfit Industries NV
35776/2MA/NP
In Commercial Distribution

  • 05420028717264 ()


  • Head/neck procedure positioner
SPECIALTY FACIAL PLASTICS PACK
MEDLINE INDUSTRIES, INC.
DYNJ62636
In Commercial Distribution

  • 10193489675108 ()
DYNJ62636

  • General surgical procedure kit, non-medicated, single-use
MINOR BASIN PACK-LF
MEDLINE INDUSTRIES, INC.
DYNJ0190652G
In Commercial Distribution

  • 10193489675092 ()
DYNJ0190652G

  • General surgical procedure kit, non-medicated, single-use
MAJOR LAPAROTOMY PACK-LF
MEDLINE INDUSTRIES, INC.
DYNJ0190806P
In Commercial Distribution

  • 10193489675085 ()
DYNJ0190806P

  • General surgical procedure kit, non-medicated, single-use
TOTAL KNEE PBM-LF
MEDLINE INDUSTRIES, INC.
DYNJ0341231L
In Commercial Distribution

  • 10193489675078 ()
DYNJ0341231L

  • General surgical procedure kit, non-medicated, single-use
3pt Head Mask - Nose Hole
Orfit Industries NV
35773/2MI/NP
In Commercial Distribution

  • 05420028717035 ()


  • Head/neck procedure positioner
PODIATRY
MEDLINE INDUSTRIES, INC.
DYNJ44669C
In Commercial Distribution

  • 10193489675054 ()
DYNJ44669C

  • General surgical procedure kit, non-medicated, single-use
3pt Head Mask - Nose Hole in Efficast 2.0 mm MAXI, no profiles
Orfit Industries NV
35773/2MA/NP
In Commercial Distribution

  • 05420028716991 ()


  • Head/neck procedure positioner
HEAD & NECK PLASTIC PBM-LF
MEDLINE INDUSTRIES, INC.
DYNJ0145531L
In Commercial Distribution

  • 10193489675030 ()
DYNJ0145531L

  • General surgical procedure kit, non-medicated, single-use
3pt Head Mask - Nose Hole in Efficast 1.6 mm MICRO, no profiles
Orfit Industries NV
35773/16MI/NP
In Commercial Distribution

  • 05420028716939 ()


  • Head/neck procedure positioner
EXTREMITY/TRAUMA PACK-LF
MEDLINE INDUSTRIES, INC.
DYNJ0190688P
In Commercial Distribution

  • 10193489675016 ()
DYNJ0190688P

  • General surgical procedure kit, non-medicated, single-use
2pt Head Mask - Nose Hole in Efficast 1.6 mm MICRO
Orfit Industries NV
35772/16MI
In Commercial Distribution

  • 05420028716755 ()


  • Head/neck procedure positioner
Aerial Couch Top for Mevion
Orfit Industries NV
32838
In Commercial Distribution

  • 05420028716649 ()


  • Radiological whole-body positioner
Aerial Couch Top for IBA + Forte
Orfit Industries NV
32827
In Commercial Distribution

  • 05420028716632 ()


  • Radiological whole-body positioner
Aerial Couch Top for IBA + Leoni
Orfit Industries NV
32826
In Commercial Distribution

  • 05420028716625 ()


  • Radiological whole-body positioner
D.I BASIC CUSTOM PK 355670
MEDLINE INDUSTRIES, INC.
DYNJV0303K
In Commercial Distribution

  • 10193489674965 ()
DYNJV0303K

  • General surgical procedure kit, non-medicated, single-use
LABOR ADMIT KIT
MEDLINE INDUSTRIES, INC.
CDS980840K
In Commercial Distribution

  • 10193489674958 ()
  • 40193489674959 ()
CDS980840K

  • General surgical procedure kit, medicated
SC LAP CHOLE
MEDLINE INDUSTRIES, INC.
DYNJ49993C
In Commercial Distribution

  • 10193489674941 ()
DYNJ49993C

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