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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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EndoSound® Ultrasound Disposable Kit (UDK-T) 5006 - 00850050934080

EndoSound Vision System (EVS) UDK-T is a disposable, single-use sterile kit that is used to attach the UTM to the compatible endoscope and provide transducer and needle articulation. UDK Sleeve Size: Inner Diameter: 9mm Wall Thickness: 1mm
Endosound, Inc.
5006
In Commercial Distribution

  • 00850050934080 ()
  • 00850050934073 ()

  • Lumen/Inner Diameter: 9 Millimeter
  • 1mm wall thickness
5005

  • General-purpose ultrasound imaging system

EndoSound® Ultrasound Disposable Kit (UDK-T) 5004 - 00850050934042

EndoSound Vision System (EVS) UDK-T is a disposable, single-use sterile kit that is used to attach the UTM to the compatible endoscope and provide transducer and needle articulation. UDK Sleeve Size: Inner Diameter: 10.5mm Wall Thickness: 0.5mm
Endosound, Inc.
5004
In Commercial Distribution

  • 00850050934042 ()
  • 00850050934004 ()

  • Lumen/Inner Diameter: 10.5 Millimeter
  • .5mm wall thickness
5003

  • General-purpose ultrasound imaging system

EndoSound® EVSScanner - 00850050934028

The EndoSound Vision System (EVS) Scanner is a small, portable, self-contained module that contains the electronics that perform ultrasound scanning and receiving functions (beamforming).
Endosound, Inc.
5000
In Commercial Distribution

  • 00850050934028 ()
5000

  • General-purpose ultrasound imaging system

EndoSound® Transducer Extension Connector (TEC) - 00850050934011

The EndoSound Transducer Extension Connector (TEC) includes the electrical connectors and cable between the EVSScanner and the UTM.
Endosound, Inc.
5002
In Commercial Distribution

  • 00850050934011 ()
5002

  • General-purpose ultrasound imaging system

Vave - 00850001977005

Phased Personal Ultrasound
Vave Health, Inc.
VP3, VA-0116
In Commercial Distribution

  • 00850001977005 ()
VP3

  • General-purpose ultrasound imaging system

HITACHI - 04580292771704

Ultrasound Diagnostic Scanner
HITACHI, LTD.
Noblus
Not in Commercial Distribution

  • 04580292771704 ()


  • General-purpose ultrasound imaging system

HITACHI - 04580292771612

Diagnostic Ultrasound Scanner
HITACHI, LTD.
HI VISION Ascendus
Not in Commercial Distribution

  • 04580292771612 ()


  • General-purpose ultrasound imaging system

ARIETTA x10 - 04573596214527

Diagnostic Ultrasound System
FUJIFILM CORPORATION
ARIETTA x10
In Commercial Distribution

  • 04573596214527 ()


  • General-purpose ultrasound imaging system

ARIETTA 650 - 04573596214381

Diagnostic Ultrasound System
FUJIFILM CORPORATION
ARIETTA 650
In Commercial Distribution

  • 04573596214381 ()


  • General-purpose ultrasound imaging system

Noblus - 04573596214169

Ultrasound Diagnostic Scanner
FUJIFILM CORPORATION
Noblus
In Commercial Distribution



  • General-purpose ultrasound imaging system
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