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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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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

LIGHTSonic B UBM - 00853386006285

No Description
LIGHTMED USA INC
US0000
In Commercial Distribution

  • 00853386006285 ()


  • 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

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

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

AXIALIS - 03700542625941

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
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