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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 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. Sleeve Size: Inner Diameter: 9.3mm Wall Thickness: 0.7mm
Endosound, Inc.
5008
In Commercial Distribution

  • 00850050934103 ()
  • 00850050934066 ()

  • Lumen/Inner Diameter: 9.3 Millimeter
  • .7mm wall thickness
5007

  • General-purpose ultrasound imaging system
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. Sleeve Size: Inner Diameter: 9.5mm Wall Thickness: 1.25mm
Endosound, Inc.
5010
In Commercial Distribution

  • 00850050934097 ()
  • 00850050934059 ()

  • Lumen/Inner Diameter: 9.5 Millimeter
  • 1.25mm wall thickness
5009

  • General-purpose ultrasound imaging system
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 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 Ultrasound Transducer Module (UTM) converts the electrical signals from the EVSScanner into ultrasound energy.
Endosound, Inc.
5001
In Commercial Distribution

  • 00850050934035 ()
5001

  • Flexible endoscopic ultrasound imaging transducer
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
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
The TPM Research model CCC-1000 Care Continuum Chair is a manual operator-propelled chair that is designed for transport and use of seated occupants with their associated medical equipment (including oxygen bottle or IV fluid bags). The product is equipped with an electronic positioning system that assists with occupant entry and exit.
Tpm Research, Inc.
CCC-1000
In Commercial Distribution

  • 00850043655008 ()


  • Stand-assistive attendant-only-propelled wheelchair
The NIRA PRO+ is a hand-held reusable OTC non-fractional diode laser device employing 1450 nm wavelength. The NIRA PRO+ consists of a hand piece, wall-plug battery charger, and 1.5 foot USB cable. The hand piece fits in the hand and the laser light comes out of the tip. There is a USB C connector interface that provides battery charging. The NIRA PRO+ is used for treatment of periorbital wrinkles.
Nira Innovations Incorporated
174-000
In Commercial Distribution

  • 00850020752454 ()


  • Dermatological laser beam guiding handpiece
The NIRA Precision Laser is a hand-held reusable OTC non-fractional diode laser device employing 1450 nm wavelength. The NIRA Laser consists of a hand piece and 1.5 foot USB cable. The hand piece fits in the hand and the laser light comes out of the tip. There is a single USB C connector interface that provides battery charging. The NIRA Laser is used for treatment of periorbital wrinkles.
Nira Innovations Incorporated
117-000
In Commercial Distribution

  • 00850020752126 ()


  • Dermatological laser beam guiding handpiece
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