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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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A native iOS and Android mobile application also compatible with iPad. It is used to: • Locate patients according to patient ID • Locate scheduled procedures by connecting to modality worklist • Capture videos, images and audio files to be included in the study case. • Add notes and tags to each file (asset). • Upload any file to the Orpheus System • Manually or automatically delete files from the file library
ORPHEUS MEDICAL LTD
01
In Commercial Distribution

  • 07290017025124 ()
ML-EG30001

  • Radiology information system application software
A native iOS and Android mobile application also compatible with iPad. It is used to: • Locate patients according to patient ID • Locate scheduled procedures by connecting to modality worklist • Capture videos, images and audio files to be included in the study case. • Add notes and tags to each file (asset). • Upload any file to the Orpheus System • Manually or automatically delete files from the file library
ORPHEUS MEDICAL LTD
01
In Commercial Distribution

  • 07290017025100 ()
MLL-EG30001

  • Radiology information system application software
Eversense NOW Remote Monitoring mobile application (iOS) is intended to be a secondary device used to remotely view an Eversense CGM System user’s glucose information.
SENSEONICS, INCORPORATED
FG-5901-01-300
In Commercial Distribution

  • 00817491021267 ()
FG-5901-01-300

  • Implantable glucose monitoring system
Bathmate Hydro 7 Crystal Clear
DX PRODUCTS LIMITED
Hydro 7 CC
In Commercial Distribution

  • 05060140209959 ()
  • 05060140209928 ()
  • 05060140209942 ()
  • 05060140209935 ()

  • Lumen/Inner Diameter: 2 Inch
  • Depth: 7 Inch
BM-H7-CC

  • Penile vacuum device
bathmate Hydromax 5 Crystal Clear
DX PRODUCTS LIMITED
Hydromax 5 CC
In Commercial Distribution

  • 05060140209836 ()
  • 05060140209805 ()
  • 05060140209829 ()
  • 05060140209812 ()

  • Lumen/Inner Diameter: 1.8 Inch
  • Depth: 5 Inch
BM-HM5-CC

  • Penile vacuum device
Bathmate Hydromax 7 Crystal Clear
DX PRODUCTS LIMITED
Hydromax 7 CC
In Commercial Distribution

  • 05060140209591 ()
  • 05060140209560 ()
  • 05060140209584 ()
  • 05060140209577 ()

  • Lumen/Inner Diameter: 2 Inch
  • Depth: 7 Inch
BM-HM7-CC

  • Penile vacuum device
Bathmate Hydromax 9 Crystal Clear
DX PRODUCTS LIMITED
Hydromax 9 CC
In Commercial Distribution

  • 05060140209379 ()
  • 05060140209362 ()

  • Lumen/Inner Diameter: 2.4 Inch
  • Depth: 9 Inch
BM-HM9-CC

  • Penile vacuum device
Bathmate Hydroxtreme 5 Crystal Clear
DX PRODUCTS LIMITED
Hydroxtreme 5 CC
In Commercial Distribution

  • 05060140209331 ()
  • 05060140209324 ()

  • Lumen/Inner Diameter: 1.8 Inch
  • Depth: 5 Inch
BM-HX5-CC

  • Penile vacuum device
Bathmate Hydroxtreme 7 Crystal Clear
DX PRODUCTS LIMITED
Hydroxtreme 7 CC
In Commercial Distribution

  • 05060140209294 ()
  • 05060140209287 ()

  • Lumen/Inner Diameter: 2 Inch
  • Depth: 7 Inch
BM-HX7-CC

  • Penile vacuum device
Bathmate Hydroxtreme 9 Crystal Clear
DX PRODUCTS LIMITED
Hydroxtreme 9 CC
In Commercial Distribution

  • 05060140209256 ()
  • 05060140209249 ()

  • Lumen/Inner Diameter: 2.4 Inch
  • Depth: 9 Inch
BM-HX9-CC

  • Penile vacuum device
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