Home GUDID 00850038195335 Eli Ezer
Primary DI 00850038195335
Brand Eli Ezer
Company U.S. OPHTHALMIC, L.L.C.
Model EZ-OPH-3600-Halogen-Lamp
Device description EZ-OPH-3600 ophthalmoscope HALOGEN Lamp
Published 2024-04-03
Public version status New
Distribution status In Commercial Distribution
MRI safety Labeling does not contain MRI Safety Information Product Codes# Code, Name table Code Name HLJ Ophthalmoscope, Battery-Powered
Product Code Classifications# Code, Device, Specialty table Code Device Specialty Class HLJ Ophthalmoscope, Battery-Powered Ophthalmic 2
Identifiers And Packaging# Identifier, Type, Agency table Identifier Type Agency Package quantity Status 00850038195335 Primary GS1 0
Alternate GTIN / UPC / EAN Codes Source identifier, GTIN-14 normalized, UPC-A table Source identifier GTIN-14 normalized UPC-A EAN-13 00850038195335 00850038195335 850038195335 0850038195335
GMDN Terms# Term, Definition table Term Definition Direct ophthalmoscope An electrically-powered, hand-held, ophthalmic instrument designed to be held close to the patient’s eye to examine the interior of the eye and related structures [e.g., fundus (retina), cornea, aqueous, lens, and vitreous] by producing an upright (unreversed) image of approximately 15 times magnification. It consists of a main unit (commonly referred to as the head) with a built-in light source directed through the pupil to illuminate the interior of the eyeball, a mirror with a single hole for viewing, and a dial containing lenses of different powers; a dedicated power supply handpiece may be included with the head.
Regulatory Flags# DUNS number 166760392 Device count 1 Premarket exempt true Serial number true Manufacturing date on label true Other Devices From This Company# Other Devices Sharing Product Codes# Primary DI, Brand, Company table Primary DI Brand Company Product code Published M368122731 Labtron GF HEALTH PRODUCTS, INC. HLJ 2020-09-22 M368122741 Labtron GF HEALTH PRODUCTS, INC. HLJ 2020-09-22 00192896009509 HEINE - BETA R HANDLE SONTEC INSTRUMENTS, INC. HLJ 2018-08-24 00192896009516 HEINE - LITHIUM ION BATTERY SONTEC INSTRUMENTS, INC. HLJ 2018-08-24 00192896009523 HEINE MPACK MINI SONTEC INSTRUMENTS, INC. HLJ 2018-08-24 00192896009530 HEINE MPACK LL BATTERY PACK SONTEC INSTRUMENTS, INC. HLJ 2018-08-24 00192896009547 HEINE MPACK UNPLUGGED BATTERY SONTEC INSTRUMENTS, INC. HLJ 2018-08-24 00192896009554 HEINE MPACK UNPLUGGED BATTERY SONTEC INSTRUMENTS, INC. HLJ 2018-08-24 00192896009561 HEINE HC 50 CONNECTING CORD SONTEC INSTRUMENTS, INC. HLJ 2018-08-24 00192896009578 HEINE MPACK SONTEC INSTRUMENTS, INC. HLJ 2018-08-24 00192896009585 HEINE MPACK COMPLETE SONTEC INSTRUMENTS, INC. HLJ 2018-08-24 00192896009592 HEINE LI-ION BATTERY SONTEC INSTRUMENTS, INC. HLJ 2018-08-24 00634782089221 Diagnostix™ AMERICAN DIAGNOSTIC CORP HLJ 2018-01-19 00634782089238 Diagnostix™ AMERICAN DIAGNOSTIC CORP HLJ 2018-01-19 00634782089252 Diagnostix™ AMERICAN DIAGNOSTIC CORP HLJ 2018-01-19 00634782089276 Diagnostix™ AMERICAN DIAGNOSTIC CORP HLJ 2018-01-19 00634782089290 Diagnostix™ AMERICAN DIAGNOSTIC CORP HLJ 2018-01-19 00634782089313 Diagnostix™ AMERICAN DIAGNOSTIC CORP HLJ 2018-01-19 00634782089320 Diagnostix™ AMERICAN DIAGNOSTIC CORP HLJ 2018-01-19 00634782088910 Diagnostix™ AMERICAN DIAGNOSTIC CORP HLJ 2018-01-12 00634782088934 Diagnostix™ AMERICAN DIAGNOSTIC CORP HLJ 2018-01-12 00634782088941 Diagnostix™ AMERICAN DIAGNOSTIC CORP HLJ 2018-01-12 00634782088958 Diagnostix™ AMERICAN DIAGNOSTIC CORP HLJ 2018-01-12 00634782088965 Diagnostix™ AMERICAN DIAGNOSTIC CORP HLJ 2018-01-12 00634782088972 Diagnostix™ AMERICAN DIAGNOSTIC CORP HLJ 2018-01-12 00634782088989 Diagnostix™ AMERICAN DIAGNOSTIC CORP HLJ 2018-01-12 00634782088996 Diagnostix™ AMERICAN DIAGNOSTIC CORP HLJ 2018-01-12 00634782087753 Diagnostix™ AMERICAN DIAGNOSTIC CORP HLJ 2018-01-12 00634782087760 Diagnostix™ AMERICAN DIAGNOSTIC CORP HLJ 2018-01-12 00634782087784 Diagnostix™ AMERICAN DIAGNOSTIC CORP HLJ 2018-01-12