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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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Orfit Industries - 05420028763230

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

Orfit Industries - 05420028763223

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

Orfit Industries - 05420028763087

AIO Indexable Knee Frame Short
Orfit Industries NV
29053
In Commercial Distribution

  • 05420028763087 ()


  • Radiological whole-body positioner

Orfit Industries - 05420028762592

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

Orfit Industries - 05420028761816

2-pin Bar for Exact™ Couch MRI compatible
Orfit Industries NV
32166
In Commercial Distribution

  • 05420028761816 ()


  • DNA-based tissue typing IVD, reagent

Orfit Industries - 05420028760451

RD Head Support - Model 7 With Lateral Neck Flaps
Orfit Industries NV
32399-MD
In Commercial Distribution

  • 05420028760451 ()


  • DNA-based tissue typing IVD, reagent

Orfit Industries - 05420028760185

2-pin Bar for Non-indexed Couch 53cm wide
Orfit Industries NV
33109
In Commercial Distribution

  • 05420028760185 ()


  • DNA-based tissue typing IVD, reagent

Orfit Industries - 05420028760079

Grip Pole Short - (set of 2 pieces)
Orfit Industries NV
32015/9/3
In Commercial Distribution

  • 05420028760079 ()


  • Radiological whole-body positioner

Orfit Industries - 05420028760062

Grip Pole Long -(set of 2 pcs)
Orfit Industries NV
32015/9/2
In Commercial Distribution

  • 05420028760062 ()


  • Radiological whole-body positioner

Orfit Industries - 05420028759707

Wedge 13.5° angle in CFL
Orfit Industries NV
32424
In Commercial Distribution

  • 05420028759707 ()


  • DNA-based tissue typing IVD, reagent

Orfit Industries - 05420028759394

AIO Anti-tilt Fixation - 2-pin Bar iBeam® Couch Top
Orfit Industries NV
33133
In Commercial Distribution

  • 05420028759394 ()


  • Radiological whole-body positioner

Orfit Industries - 05420028758977

Prodigy™ Fix MRI compatible
Orfit Industries NV
32066
In Commercial Distribution

  • 05420028758977 ()


  • DNA-based tissue typing IVD, reagent

Orfit Industries - 05420028758823

AIO Arm rest adapter
Orfit Industries NV
29036
In Commercial Distribution

  • 05420028758823 ()


  • Radiological whole-body positioner

Orfit Industries - 05420028758625

Indexing bar for vacuum bags
Orfit Industries NV
18059
In Commercial Distribution

  • 05420028758625 ()


  • Radiological whole-body positioner

Orfit Industries - 05420028758441

Transparent hose ID4 (2 m)
Orfit Industries NV
18054
In Commercial Distribution

  • 05420028758441 ()


  • Radiological whole-body positioner

Orfit Industries - 05420028757581

Prone Breastboard support cushion for contralateral breast
Orfit Industries NV
32054-V2
In Commercial Distribution

  • 05420028757581 ()


  • Radiological whole-body positioner

Orfit Industries - 05420028757352

Adapter Plate for 2-pin Indexing Bar 12 mm Base Plate
Orfit Industries NV
35747/6
In Commercial Distribution

  • 05420028757352 ()


  • DNA-based tissue typing IVD, reagent

Orfit Industries - 05420028757338

Horizontal Grip Pole
Orfit Industries NV
32015/10
In Commercial Distribution

  • 05420028757338 ()


  • Radiological whole-body positioner

Orfit Industries - 05420028757130

Grip Pole Collar
Orfit Industries NV
32015/9/1
In Commercial Distribution

  • 05420028757130 ()


  • Radiological whole-body positioner

Orfit Industries - 05420028757123

Grip Pole Complete System
Orfit Industries NV
32015/9
In Commercial Distribution

  • 05420028757123 ()


  • Radiological whole-body positioner

Orfit Industries - 05420028756683

2-pin Bar for Prodigy™ Couch couch width 53 cm - MR safe
Orfit Industries NV
32165
In Commercial Distribution

  • 05420028756683 ()


  • DNA-based tissue typing IVD, reagent

Orfit Industries - 05420028756621

Paediatric LD Head Support - Model 8 With Lateral Neck Flaps
Orfit Industries NV
35753-80
In Commercial Distribution

  • 05420028756621 ()


  • DNA-based tissue typing IVD, reagent

Orfit Industries - 05420028755884

Head Support Interface for push-pin Base Plates
Orfit Industries NV
32048
In Commercial Distribution

  • 05420028755884 ()


  • DNA-based tissue typing IVD, reagent

Orfit Industries - 05420028755792

Indexing Screws for iBeam® Couch MRI compatible - set of 4
Orfit Industries NV
32126
In Commercial Distribution

  • 05420028755792 ()


  • DNA-based tissue typing IVD, reagent

Orfit Industries - 05420028755648

Uon® Head Mask +Neck Flap
Orfit Industries NV
60097/EFF2MA
In Commercial Distribution

  • 05420028755648 ()


  • Head/neck procedure positioner

Orfit Industries - 05420028755570

4pt Hybrid Lung Mask with push pins Eff 2 MI - Nanor 12MI+
Orfit Industries NV
33788/2MI/12MI+N
In Commercial Distribution

  • 05420028755570 ()


  • Head/neck procedure positioner

Orfit Industries - 05420028755457

Pressure Belt with Manual Pump with belt of 130 cm
Orfit Industries NV
32317/18
In Commercial Distribution

  • 05420028755457 ()


  • Radiological whole-body positioner

Materialise Personalized Solutions - 05420060343391

Upper Extremity Guide and Model
Materialise NV
O-01-0-100000-0021-020
In Commercial Distribution

  • 05420060343391 ()
O-01-0-100000-0021-020

  • Custom-made organ/bone anatomy model/surgical guide kit

Medline Industries, Inc. - 10193489682809

SHOULDER PACK
MEDLINE INDUSTRIES, INC.
DYNJ51568B
In Commercial Distribution

  • 10193489682809 ()
  • 40193489682800 ()
DYNJ51568B

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

Medline Industries, Inc. - 10193489682793

PODIATRY PACK
MEDLINE INDUSTRIES, INC.
DYNJ51567B
In Commercial Distribution

  • 10193489682793 ()
  • 40193489682794 ()
DYNJ51567B

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

Materialise Personalized Solutions - 05420060343322

Femur Osteotomy Guide and Model
Materialise NV
O-01-0-306000-0011-010
In Commercial Distribution

O-01-0-306000-0011-010

  • Custom-made organ/bone anatomy model/surgical guide kit

Materialise Personalized Solutions - 05420060343315

Tibia/Fibula Osteotomy Guide and Model
Materialise NV
O-01-0-303000-0011-010
In Commercial Distribution

O-01-0-303000-0011-010

  • Custom-made organ/bone anatomy model/surgical guide kit

Materialise Personalized Solutions - 05420060343308

Clavicle Osteotomy Guide and Model
Materialise NV
O-01-0-828000-0011-000
In Commercial Distribution

O-01-0-828000-0011-000

  • Custom-made organ/bone anatomy model/surgical guide kit

Materialise Personalized Solutions - 05420060343292

Hand Osteotomy Guide and Model
Materialise NV
O-01-0-200000-0011-010
In Commercial Distribution

O-01-0-200000-0011-010

  • Custom-made organ/bone anatomy model/surgical guide kit

Medline Industries, Inc. - 10193489682731

OPEN HEART CDS
MEDLINE INDUSTRIES, INC.
CDS983451L
In Commercial Distribution

  • 10193489682731 ()
CDS983451L

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

Medline Industries, Inc. - 10193489682724

RADIOLOGY SPECIALS PACK
MEDLINE INDUSTRIES, INC.
PHS479840M
In Commercial Distribution

  • 10193489682724 ()
  • 40193489682725 ()
PHS479840M

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

Medline Industries, Inc. - 10193489682700

ANGIO PACK
MEDLINE INDUSTRIES, INC.
DYNJ62693
In Commercial Distribution

  • 10193489682700 ()
  • 40193489682701 ()
DYNJ62693

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

Medline Industries, Inc. - 10193489682694

THORPE DENTAL ACCESSORY KIT
MEDLINE INDUSTRIES, INC.
DYKM1829
In Commercial Distribution

  • 10193489682694 ()
DYKM1829

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

Medline Industries, Inc. - 10193489682687

SINGLE SHOT EPIDURAL TRAY
MEDLINE INDUSTRIES, INC.
PAIN1440
In Commercial Distribution

  • 10193489682687 ()
  • 40193489682688 ()
PAIN1440

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

Medline Industries, Inc. - 10193489682670

NERVE BLOCK TRAY
MEDLINE INDUSTRIES, INC.
PAIN1441
In Commercial Distribution

  • 10193489682670 ()
  • 40193489682671 ()
PAIN1441

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

Medline Industries, Inc. - 10193489682663

BURR HOLE SHUNT PACK
MEDLINE INDUSTRIES, INC.
DYNJ56819C
In Commercial Distribution

  • 10193489682663 ()
DYNJ56819C

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

Medline Industries, Inc. - 10193489682656

SPINAL PACK
MEDLINE INDUSTRIES, INC.
DYNJ56800C
In Commercial Distribution

  • 10193489682656 ()
DYNJ56800C

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

Medline Industries, Inc. - 10193489682649

CRANIOTOMY PACK
MEDLINE INDUSTRIES, INC.
DYNJ56799C
In Commercial Distribution

  • 10193489682649 ()
DYNJ56799C

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

Medline Industries, Inc. - 10193489682632

CYSTO PACK
MEDLINE INDUSTRIES, INC.
DYNJ55135C
In Commercial Distribution

  • 10193489682632 ()
  • 40193489682633 ()
DYNJ55135C

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

Medline Industries, Inc. - 10193489682625

NERVE BLOCK TRAY
MEDLINE INDUSTRIES, INC.
DYNJRA0709I
In Commercial Distribution

  • 10193489682625 ()
  • 40193489682626 ()
DYNJRA0709I

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

Medline Industries, Inc. - 10193489682618

PAIN MGMT PREP TRAY
MEDLINE INDUSTRIES, INC.
DYNJRA1236A
In Commercial Distribution

  • 10193489682618 ()
  • 40193489682619 ()
DYNJRA1236A

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

Medline Industries, Inc. - 10193489682601

SC HEAD AND NECK PACK
MEDLINE INDUSTRIES, INC.
DYNJ49992C
In Commercial Distribution

  • 10193489682601 ()
DYNJ49992C

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

Medline Industries, Inc. - 10193489682595

SC HAND
MEDLINE INDUSTRIES, INC.
DYNJ49991F
In Commercial Distribution

  • 10193489682595 ()
DYNJ49991F

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

Medline Industries, Inc. - 10193489682588

SIDE SHEET DRAPE PACK
MEDLINE INDUSTRIES, INC.
DYNJ50005B
In Commercial Distribution

  • 10193489682588 ()
  • 40193489682589 ()
DYNJ50005B

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

Medline Industries, Inc. - 10193489682571

SC VAG HYST
MEDLINE INDUSTRIES, INC.
DYNJ50004D
In Commercial Distribution

  • 10193489682571 ()
DYNJ50004D

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