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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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Diagnostic Ultrasound System Accessory
FUJIFILM SONOSITE, INC.
P12163-13
In Commercial Distribution

  • 00841517100070 ()


  • General-purpose ultrasound imaging system
Diagnostic Ultrasound System Accessory
FUJIFILM SONOSITE, INC.
P12738-31
In Commercial Distribution

  • 00841517100063 ()


  • General-purpose ultrasound imaging system
Diagnostic Ultrasound Transducer
FUJIFILM SONOSITE, INC.
P07678-70
In Commercial Distribution

  • 00841517100056 ()


  • General-purpose ultrasound imaging system
The Cerviray is a handheld device that includes imaging optics, provides sequentially captured images of the cervix. The image can be viewed on the touch screen display. It typically consists of an illuminated lens and video camera unit connected to an LCD touch screen display. During use, Cerviray is used with the speculum(not provided) to keep a certain distance to obtain good quality of image and prevent direct contact with patient. The Cradle is also included for charging purpose only.
AIDOT
ADT-CC10
In Commercial Distribution

  • 08800126000050 ()
  • 18800126000057 ()
D-23-090

  • Colposcope
CLAROX is a battery-operated, portable dental X-ray source designed for handheld operation. It is designed to produce diagnostic quality X-ray images. The CLAROX is designed for use in a dental office. It can also be used in other similar environments (orthodontic office, general practitioner’s office, hospital ward, etc.) where appropriate safeguards are implemented. The device uses a rechargeable battery to allow for the use of the CLAROX where transportation or use of other x-ray devices might be prohibitive due to the other device’s size and/or lack of mobility. The CLAROX is an X-ray device with an AC/DC adaptor. The handheld device features a main body (tube head), Cone for sensor, Acryl shielding, cradle, and AC/DC adaptor.
VSI Co., Ltd.
VX-30
In Commercial Distribution

  • 18800124900007 ()
  • 08800124900000 ()
VX-30

  • Hand-held intraoral dental x-ray system, digital
CODMAN HAKIM Valve Programmer, 100-240V
Cerenovus, Inc.
82-3190
Not in Commercial Distribution

  • 10886704041597 ()
823190

  • Cerebrospinal fluid shunt valve programmer
CODMAN HAKIM Valve Programmer, 100-240V, IEC NOTICE: Do not exceed the following transport and storage conditions. Temperature -40 DEGREES C - +60 DEGREES C Relative Humidity 10 Percent - 85 Percent Atmospheric Pressure 500hPa - 1060hPa
Cerenovus, Inc.
823190R
Not in Commercial Distribution

  • 10886704078616 ()
823190R

  • Cerebrospinal fluid shunt valve programmer
CODMAN VPV System Contents: One Each: CODMAN VPV Program Unit, CODMAN VPV Transmitter Unit, Power Cord, Ultrasound Gel, Instructions for Use, and Carrying Case
Cerenovus, Inc.
823192R
Not in Commercial Distribution

  • 10886704078609 ()
823192R

  • Cerebrospinal fluid shunt valve programmer
CSPOLA600F is an automatic visual acuity system, stand-alone type, which displays broad range of charts, based on LCD panel, including red /green for the eye optometry. The chart rotation for CSPOLA600F can be performed by wireless remote control or by wired external devices such as the control box of Digital Phoropter. Unlike existing chart projector, CSPOLA600F is able to provide wider range of charts (more than 100 kinds of general and special charts) on LCD panel and the product can be adjusted at the level of the patients for precise examination.
VIEW-M TECHNOLOGY CO., LTD.
CSPOLA600F
In Commercial Distribution

  • 08800074500305 ()
CSPOLA600F

  • Visual acuity light box
CSPOLA600C is an automatic visual acuity system, stand-alone type, which displays broad range of charts, based on LCD panel, including red /green for the eye optometry. The chart rotation for CSPOLA600C can be performed by wireless remote control or by wired external devices such as the control box of Digital Phoropter. Unlike existing chart projector, CSPOLA600C is able to provide wider range of charts (more than 100 kinds of general and special charts) on LCD panel and the product can be adjusted at the level of the patients for precise examination.
VIEW-M TECHNOLOGY CO., LTD.
CSPOLA600C
In Commercial Distribution

  • 08800074500299 ()
CSPOLA600C

  • Visual acuity light box
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