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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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LessRay - 00887517756787

LessRay Radix Lens', 40 Pack
Nuvasive, Inc.
8230019
In Commercial Distribution

  • 00887517756787 ()


  • Diagnostic x-ray digital imaging system workstation

LessRay - 00887517805997

LessRay Remote, Wired
Nuvasive, Inc.
8230022
In Commercial Distribution

  • 00887517805997 ()


  • Diagnostic x-ray digital imaging system workstation

VUZE System 2.0 - 07290019776000

The VUZE System (the “System”) enables users to load pre-operative 3D images and planning data and register and overlay this data in real time with intra-operative 2D radiographic images of the same anatomy. The System supports device guidance during minimally invasive spinal surgery, including the stabilization of the spine by means of fixation, fixation coupled with fusion, vertebroplasty or kyphoplasty. Applicable vertebrae are within the range of S1 through T7. The user of the VUZE System is a surgeon with the required qualifications for performing applicable spine surgeries. The System offers pre-operative surgical planning, including implant screw sizing and trajectory determination, as well as intra-operative assistance along the insertion of typical surgical tools (including tools used for placing implants) relative to rigid spinal structures.
VUZE MEDICAL LTD
VM-PK-001
In Commercial Distribution

  • 07290019776000 ()
  • 07290019776017 ()
VM-PK-001

  • Diagnostic x-ray digital imaging system workstation

Orfit Industries - 05420028702079

set of 6 models Head support regular density extra soft (for Push Pin Hardware)
Orfit Industries NV
32450
In Commercial Distribution

  • 05420028702079 ()


  • DNA-based tissue typing IVD, reagent

Skytron 32" Shelf with stainless steel top E3 - 10841736113988

32" Shelf with stainless steel top for XM, VBM, CM carriers, includes mounting hardware
SKYTRON LLC
3XMSHSS
In Commercial Distribution

  • 10841736113988 ()


  • General utility supply system, ceiling-mounted

Skytron 22" Shelf with stainless steel top E3 - 10841736113919

22" Shelf with stainless steel top for PM, VBM, CM carriers, includes mounting hardware
SKYTRON LLC
3PMSHSS
In Commercial Distribution

  • 10841736113919 ()


  • General utility supply system, ceiling-mounted

Skytron 16.5" Shelf with stainless steel top E3 - 10841736113889

16.5" Shelf with stainless steel top for KM, VBM, CM carriers, includes mounting hardware
SKYTRON LLC
3KMSHSS
In Commercial Distribution

  • 10841736113889 ()


  • General utility supply system, ceiling-mounted

Axiom - 00840363368993

4 x 5 Lateral Pads, Curved with S/A Mounting Hardware for BTX Right
KI MOBILITY, LLC
Lateral Trunk Supports
In Commercial Distribution

  • 00840363368993 ()

  • Width: 5 Inch
  • Length: 4 Inch
PLLSC4x5BR

  • Wheelchair head/trunk support, prefabricated

Axiom - 00840363368986

3 x 4 Lateral Pads, Curved with S/A Mounting Hardware for BTX Right
KI MOBILITY, LLC
Lateral Trunk Supports
In Commercial Distribution

  • 00840363368986 ()

  • Length: 3 Inch
  • Width: 4 Inch
PLLSC3x4BR

  • Wheelchair head/trunk support, prefabricated

Axiom - 00840363368979

4 x 5 Lateral Pads, Flat with S/A Mounting Hardware for BTX Right
KI MOBILITY, LLC
Lateral Trunk Supports
In Commercial Distribution

  • 00840363368979 ()

  • Length: 4 Inch
  • Width: 5 Inch
PLLS4x5BR

  • Wheelchair head/trunk support, prefabricated
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