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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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QUANTUM - 33701337605668

QUANTUM CORNER CHISEL FOR TIBIAL PREPARATION
IN2BONES
M05 01241
In Commercial Distribution

  • 33701337605668 ()
M05 01241

  • Orthopaedic chisel

QUANTUM - 03701337605520

QUANTUM Tibial Implant Guide
IN2BONES
M05 00731
In Commercial Distribution

  • 03701337605520 ()

  • Length: 28 Millimeter
  • Height: 31.8 Millimeter
M05 00731

  • Orthopaedic instrument surgical connector

QUANTUM - 03701337602659

QUANTUM Talar Implant Flat Cut Right Size 4
IN2BONES
M50 SC144
In Commercial Distribution

  • 03701337602659 ()

  • Length: 38.91 Millimeter
  • Length: 3303 Millimeter
M50 SC144

  • Fixed-bearing total ankle prosthesis

QUANTUM - 03701337601157

QUANTUM Resection Guide For Talar Chamfer S6
IN2BONES
M05 01031
In Commercial Distribution

  • 03701337601157 ()

  • Length: 72.69 Millimeter
  • Width: 36.26 Millimeter
M05 01031

  • Osteotomy guide, reusable

Varian AI Segmentation - 00856100006233

No Description
VARIAN MEDICAL SYSTEMS, INC.
1.1
In Commercial Distribution

  • 00856100006233 ()


  • Radiation therapy software

Varian AI Segmentation - 00856100006172

No Description
VARIAN MEDICAL SYSTEMS, INC.
1.0
In Commercial Distribution

  • 00856100006172 ()


  • Radiation therapy software

ProFound AI 3.1 - 00850008977275

No Description
Icad, Inc.
3.1
In Commercial Distribution

  • 00850008977275 ()


  • Radiology DICOM image processing application software

ProFound AI 3.1 - 00850008977268

No Description
Icad, Inc.
3.1
In Commercial Distribution

  • 00850008977268 ()


  • Radiology DICOM image processing application software

ProFound AI V3.0 - 00850008977176

No Description
Icad, Inc.
3.0
In Commercial Distribution

  • 00850008977176 ()


  • Basic diagnostic x-ray system application software

OrthoGrid Hip AI - 00860003424834

OrthoGrid Hip AI for non-invasive software system that provides image analysis tools for Total Hip Replacement
Orthogrid Systems, Inc.
1015-915-505
In Commercial Distribution

  • 00860003424834 ()


  • Orthopaedic fluoroscopic grid software
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