EUROLIGHT E30, 2.5V ophthalmoscope with clic-closure 01.21300.001

GUDID 04030155000392

Kirchner & Wilhelm GmbH + Co KG

Direct ophthalmoscope
Primary Device ID04030155000392
NIH Device Record Key9dd802c6-6b2b-43ff-a1af-eac4cd9c79e3
Commercial Distribution StatusIn Commercial Distribution
Brand NameEUROLIGHT E30, 2.5V ophthalmoscope with clic-closure
Version Model Number01.21300.001
Catalog Number01.21300.001
Company DUNS315480269
Company NameKirchner & Wilhelm GmbH + Co KG
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usefalse
Lot Batchtrue
Serial Numberfalse
Manufacturing Datetrue
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptionfalse
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS104030155000392 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

HLJOphthalmoscope, Battery-Powered

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2023-09-12
Device Publish Date2023-09-04

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04030155000392 - EUROLIGHT E30, 2.5V ophthalmoscope with clic-closure2023-09-12
04030155000392 - EUROLIGHT E30, 2.5V ophthalmoscope with clic-closure2023-09-12

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