OptiLux LED Illuminator

GUDID 01816835024215

LED Illuminator, Portable, Domestic

Medical Illumination International Inc.

Endoscopic light source adaptor Endoscopic light source adaptor Endoscopic light source adaptor Endoscopic light source adaptor Endoscopic light source adaptor Endoscopic light source adaptor Endoscopic light source adaptor Endoscopic light source adaptor Endoscopic light source adaptor Endoscopic light source adaptor Endoscopic light source adaptor Endoscopic light source adaptor Endoscopic light source adaptor Endoscopic light source adaptor Endoscopic light source adaptor Endoscopic light source adaptor Endoscopic light source adaptor General-purpose light source General-purpose light source General-purpose light source General-purpose light source General-purpose light source General-purpose light source General-purpose light source General-purpose light source General-purpose light source General-purpose light source General-purpose light source General-purpose light source General-purpose light source General-purpose light source General-purpose light source General-purpose light source
Primary Device ID01816835024215
NIH Device Record Key7b57707c-9345-4d85-aebe-ac78b1c602e7
Commercial Distribution StatusIn Commercial Distribution
Brand NameOptiLux LED Illuminator
Version Model NumberIL-2386 DOM
Company DUNS093357739
Company NameMedical Illumination International Inc.
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 Batchfalse
Serial Numbertrue
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
GS100816835024216 [Primary]
GS101816835024215 [Package]
Contains: 00816835024216
Package: BOX [1 Units]
In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

HBIIlluminator, Fiberoptic, Surgical Field

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2023-10-10
Device Publish Date2023-10-02

On-Brand Devices [OptiLux LED Illuminator]

01816835024246LED Illuminator, w/ Mobile Floor Stand, International
01816835024239LED Illuminator, w/ Mobile Floor Stand, Domestic
01816835024222LED Illuminator, Portable, International
01816835024215LED Illuminator, Portable, Domestic

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