FDA.reportPublic FDA data

EUROLIGHT E30, 2.5V ophthalmoscope with clic-closure

Primary DI
04030155000392
Brand
EUROLIGHT E30, 2.5V ophthalmoscope with clic-closure
Company
Kirchner & Wilhelm GmbH + Co KG
Model
01.21300.001
Catalog number
01.21300.001
Published
2023-09-04
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Product Codes#

Code, Name table
CodeName
HLJOphthalmoscope, Battery-Powered

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HLJOphthalmoscope, Battery-PoweredOphthalmic2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K070270000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K070270000PICCOLIGHT E50,PICCOLIGHT E56,EUROLIGHT E10, EUROLIGHT E30, AND EUROLIGHT E36Kirchner & Wilhelm GmbH + Co.Kg2007-11-05HLJ

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
04030155000392PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04030155000392040301550003924030155000392

GMDN Terms#

Term, Definition table
TermDefinition
Direct ophthalmoscopeAn 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.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
315480269
Device count
1
Lot or batch
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
04030155008480MedCharge 4000 battery charger compl. with mains adaptor12.80005.00212.80005.0022025-10-27
04030155004819Colorscop-duo stethoscope, pink06.22100.13406.22100.1342023-09-12
04030155004970Standard-Prestige stethoscope stainless steel, black06.22700.02206.22700.0222023-09-12
04030155005076Planet double stethoscope according to Fassbender06.22900.02206.22900.0222023-09-12
04030155005168Ear tips, black, Ø 5,5 mm, PU: 10 pcs. W. white turned parts06.91111.02106.91111.0212023-09-12
04030155011695Stethoscope double tube, black, length 60cm06.93265.02106.93265.0212023-09-12
04030155019448Planet Air stethoscope06.22910.12206.22910.1222023-09-12
04030155004987Standard-Prestige stethoscope stainless steel, blue06.22700.03206.22700.0322024-01-11
04030155004994Standard-Prestige stethoscope stainless steel, burgundy06.22700.17206.22700.1722024-01-11
04030155005007Baby-Prestige stethoscope stainless steel, black06.22701.02206.22701.0222024-01-11
04030155005038Children-Prestige stethoscope stainless steel, blue06.22702.03206.22702.0322024-01-11
04030155018960Children-Prestige stethoscope stainless steel, black06.22702.02206.22702.0222024-01-11
04030155019011Baby-Prestige stethoscope stainless steel, blue06.22701.03206.22701.0322024-01-11
04030155000774Reusable ear funnels Ø 4.0 mm, 10 pcs.01.72213.0012024-07-24
04030155001542BASIC-SET COMBILIGHT C10/E10 ophthalmoscope and otoscope02.11001.00202.11001.0022023-09-04
04030155010346PICCOLIGHT C otoscope, sky with ear funnels, cloth bag01.13100.23201.13100.2322023-09-04
04030155010353PICCOLIGHT C otoscope, stone with ear funnels, cloth bag01.13100.26201.13100.2622023-09-04
04030155010414PICCOLIGHT F.O. LED standard, otoscope, stone01.13500.26201.13500.2622023-09-04
04030155013392MedCenter 5000 wall mounted set, ear funnels module02.84001.00202.84001.0022023-09-04
04030155013415MedCenter 5000 wall mounted Set F.O./E56, US02.85020.00202.85020.0022023-09-04

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