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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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40MHZKIT-USA - 09342395002278

No Description
ELLEX MEDICAL PTY LTD
40MHZ ACCESSORY KIT-USA
In Commercial Distribution

  • 09342395002278 ()


  • Ophthalmic ultrasound imaging system

Eye Cubed V4 New Gen - 09342395001370

No Description
ELLEX MEDICAL PTY LTD
I3 SYSTEM-ABDU
In Commercial Distribution

  • 09342395001370 ()


  • Ophthalmic ultrasound imaging system

Ellex - 09342395001325

WINDOWS 7 UPGRADE KIT, V4 EYE CUBED
ELLEX MEDICAL PTY LTD
6448971
In Commercial Distribution

  • 09342395001325 ()


  • Ophthalmic ultrasound imaging system

Ellex - 09342395001318

WINDOWS 7 UPGRADE KIT, NEW GENERATION EYE CUBED
ELLEX MEDICAL PTY LTD
6448970
In Commercial Distribution

  • 09342395001318 ()


  • Ophthalmic ultrasound imaging system

Ellex - 09342395001301

40MHZ ACCESSORY KIT
ELLEX MEDICAL PTY LTD
EYECUBED-40MHZKIT
In Commercial Distribution

  • 09342395001301 ()


  • Ophthalmic ultrasound imaging system

Ellex - 09342395000373

FGOODS, EYE PRIME
ELLEX MEDICAL PTY LTD
EYEPRIME
In Commercial Distribution

  • 09342395000373 ()


  • Ophthalmic ultrasound imaging system

Ellex - 09342395000274

FGOODS, EYEONE
ELLEX MEDICAL PTY LTD
EYEONE
In Commercial Distribution

  • 09342395000274 ()


  • Ophthalmic ultrasound imaging system

Ultrasound Biomicroscope - 06948941132005

MD-320W Ultrasound Biomicroscope is an ultrasonic imaging system with high-resolution. It is intended to be used in clinical ophthalmology for ultrasonic diagnosis on the anterior segment of eyes.
Meda Co., Ltd
MD-320W
In Commercial Distribution

  • 06948941132005 ()


  • Ophthalmic ultrasound imaging system

Ultrasonic Biometer for Ophthalmology - 06948941111109

MD-1000A Ultrasonic Biometer for Ophthalmology is an ultrasonic measuring medical device based on pulse reflection. It’s intended for measurements of biometric parameters.
Meda Co., Ltd
MD-1000A
In Commercial Distribution

  • 06948941111109 ()


  • Ophthalmic ultrasound imaging system

Ultrasonic A/B Scanner for Ophthalmology - 06948941102237

MD-2300S Ultrasonic A/B Scanner for Ophthalmology is an ultrasonic imaging medical device intended for ophthalmological ultrasonic diagnosis and biometric measurement.
Meda Co., Ltd
MD-2300S
In Commercial Distribution

  • 06948941102237 ()


  • Ophthalmic ultrasound imaging system
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