Home GUDID M368122721 Labtron
Primary DI M368122721
Brand Labtron
Company GF HEALTH PRODUCTS, INC.
Model 1227-2
Device description Standard Ophthalmoscope Set
Published 2016-08-31
Public version status Update
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 M368122722 Package HIBCC 20 In Commercial Distribution M368122721 Primary HIBCC 0
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 built-in light 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.
Regulatory Flags# DUNS number 132016168 Device count 1 Premarket exempt true Kit true Lot or batch true Other Devices From This Company# Other Devices Sharing Product Codes# Primary DI, Brand, Company table Primary DI Brand Company Product code Published 04053755203550 OMEGA 600 VET Heine Optotechnik GmbH & Co. KG HLJ 2026-09-22 06945095556107 zumax Zumax Medical Co., LTD HLJ 2026-07-06 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 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
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