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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 Class Implantable

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Eli Ezer - 00851158007287

No Description
U.S. OPHTHALMIC, L.L.C.
EUS-2600
In Commercial Distribution

  • 00851158007287 ()


  • Ophthalmic ultrasound imaging system

Gilras - 00851158007089

No Description
U.S. OPHTHALMIC, L.L.C.
GRU-5000 A/P
In Commercial Distribution

  • 00851158007089 ()


  • Ophthalmic ultrasound imaging system

Gilras - 00851158007065

No Description
U.S. OPHTHALMIC, L.L.C.
GRU-6000
In Commercial Distribution

  • 00851158007065 ()


  • Ophthalmic ultrasound imaging system

Gilras - 00851158007058

No Description
U.S. OPHTHALMIC, L.L.C.
GRU-7000
In Commercial Distribution

  • 00851158007058 ()


  • Ophthalmic ultrasound imaging system

PalmScan P2000FP - 00853569007023

P2000 FP is a Portable Pachymeter SYSTEM, IMAGING, PULSED ECHO, ULTRASONIC
Micro Medical Devices, Inc.
P2000FP
In Commercial Distribution

  • 00853569007023 ()
900-0005-01

  • Ophthalmic ultrasound imaging system

LIGHTSonic B UBM - 00853386006285

No Description
LIGHTMED USA INC
US0000
In Commercial Distribution

  • 00853386006285 ()


  • Ophthalmic ultrasound imaging system

Scanmate A - 00857377006094

The DGH 6000 is a Portable Ultrasonic A-Scan. It is an electronic device that connects to the user's PC via USB connection. It is a portable device that uses ultrasonic pulse technology to obtain axial length measurements of the human eye
DGH TECHNOLOGY INC.
DGH 6000
In Commercial Distribution

  • 00857377006094 ()


  • Ophthalmic ultrasound imaging system

AXIS NANO - 03700542625033

Ophthalmic Ultrasound Biometer: Biometry and IOL Calculation The QUANTEL MEDICAL AXIS NANO Ophthalmic Ultrasound System and the probes that are used with it are indicated for the biometric measurement of the eye including: • Axial Length measurement of the eye by ultrasonic means. • Implanted IOL power calculation, using the Axial Length measurement.
QUANTEL MEDICAL
AXIS NANO
In Commercial Distribution

  • 03700542625033 ()


  • Ophthalmic ultrasound imaging system

COMPACT TOUCH STS - 03700542625026

Ophthalmic Ultrasound Biomicroscope UBM and automatic STS measurement for ICL sizing The QUANTEL MEDICAL Compact Touch STS UBMTM Ophthalmic Ultrasound System (and its associated Linear 50 MHz probe) is intended to be used for diagnostic imaging and measurement of the eye including: • Visualization of the interior of the eye by B scans. • Make measurements inside the eye (Sulcus to Sulcus, Irido Cornea Angle Left, Irido Cornea Angle Right, Lens curvature and Anterior Chamber depth).
QUANTEL MEDICAL
COMPACT TOUCH STS UBM
In Commercial Distribution

  • 03700542625026 ()


  • Ophthalmic ultrasound imaging system

COMPACT TOUCH - 03700542625019

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
In Commercial Distribution

  • 03700542625019 ()


  • Ophthalmic ultrasound imaging system
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