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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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Curved Probe SC6-1 Gen II®
Supersonic Imagine, Inc.
SSIP92030
In Commercial Distribution

  • 03760193600032 ()

  • Length: 250 Centimeter
SSIP92030

  • General-purpose ultrasound imaging system
Linear Probe SL15-4 Gen II®
Supersonic Imagine, Inc.
SSIP92002
In Commercial Distribution

  • 03760193600025 ()

  • Length: 250 Centimeter
SSIP92002

  • General-purpose ultrasound imaging system
Imaging Ultrasound Diagnostic System
Supersonic Imagine, Inc.
SSIP92029
In Commercial Distribution

  • 03760193600018 ()

  • Length: 250 Centimeter
SSIP92029

  • General-purpose ultrasound imaging system
Endocavitary Probe SEV12-3 GEN II
Supersonic Imagine, Inc.
SSIP93189
In Commercial Distribution

  • 03760193600001 ()

  • Length: 250 Centimeter
SSIP93189

  • General-purpose ultrasound imaging system
The AXIALIS Ophthalmic Ultrasound System and the probes that are used with it are indicated for diagnostic imaging and biometric measurement of the eye including: • Axial Length measurement of the eye by ultrasonic means. • Implanted IOL power calculation, using the Axial Length measurement. • Measurement of corneal thickness by ultrasonic means.
QUANTEL MEDICAL
AXIALIS
In Commercial Distribution

  • 03700542625941 ()


  • Ophthalmic ultrasound imaging system
The laser (577 nm Fiber Techology Laser SingleSpot, MultiSpot and Subliminal mode and Slit Lamp Zeiss mode) is a photocoagulator device intended for the treatment of retinal diseases.
QUANTEL MEDICAL
EASYRET
In Commercial Distribution

  • 03700542625927 ()


  • Ophthalmic solid-state laser system
The Vitra 810 is a laser system which emits a treatment beam at 810 nm and is intended for use in photocoagulation of ocular tissues in the treatment of diseases of the eye. The laser is used to treat the retinal diseases and glaucoma.
QUANTEL MEDICAL
VITRA 810
In Commercial Distribution

  • 03700542625613 ()


  • Ophthalmic solid-state laser system
The VITRA 2 is a laser system which emits a treatment beam at 532 nm and is intended for use in photocoagulation of ocular tissues in the treatment of diseases of the eye.
QUANTEL MEDICAL
VITRA 2
In Commercial Distribution

  • 03700542625569 ()


  • Ophthalmic solid-state laser system
Ophthalmic Ultrasound System: A/B Scan and Pachymetry The QUANTEL MEDICAL COMPACT TOUCH Ophthalmic Ultrasound System and the probes that are used with it are indicated for diagnostic imaging and biometric measurement of the eye including: • Visualization of the interior of the eye and the orbit by A and B scans. • Axial Length measurement of the eye by ultrasonic means. • Implanted IOL power calculation, using the Axial Length measurement. • Measurement of corneal thickness by ultrasonic means.
QUANTEL MEDICAL
COMPACT TOUCH 2017
In Commercial Distribution

  • 03700542625545 ()


  • Ophthalmic ultrasound imaging system
15 MHz Probe for eye and orbit examination. Automatic biometry readings obtained from a B mode image allowing axial length measurements for difficult to mesure long eyes or posterior staphyloma.
QUANTEL MEDICAL
B1 COMPACT TOUCH 2017
In Commercial Distribution

  • 03700542625538 ()


  • Ophthalmic ultrasound imaging transducer
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