IsoLED Mini LED HL

GUDID 01816835023973

IsoLED mini LEDHL, Attached to Headgear

Medical Illumination International Inc.

Head-worn lamp Head-worn lamp Head-worn lamp Head-worn lamp Head-worn lamp Head-worn lamp Head-worn lamp Head-worn lamp Head-worn lamp Head-worn lamp Head-worn lamp Head-worn lamp Head-worn lamp Head-worn lamp Head-worn lamp Head-worn lamp Head-worn lamp Head-worn lamp Head-worn lamp Head-worn lamp Head-worn lamp Head-worn lamp Head-worn lamp Head-worn lamp
Primary Device ID01816835023973
NIH Device Record Key247400be-8386-4585-9aae-a037487794f6
Commercial Distribution StatusIn Commercial Distribution
Brand NameIsoLED Mini LED HL
Version Model NumberIL-2429
Company DUNS093357739
Company NameMedical Illumination International Inc.
Device Count1
DM Exemptfalse
Pre-market Exempttrue
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
GS100816835023974 [Primary]
GS101816835023973 [Package]
Contains: 00816835023974
Package: BOX [1 Units]
In Commercial Distribution

FDA Product Code

FCTHeadlight, Fiberoptic Focusing
HPPHeadlamp, Operating, Battery-Operated

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 [IsoLED Mini LED HL]

01816835023973IsoLED mini LEDHL, Attached to Headgear
01816835023966IsoLED mini LEDHL, Attached to Safety Glasses
00816835023950IsoLED mini LEDHL, Standard, w/Mounting Clips

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