LUVIS-C300 Series

GUDID 08800053083867

AC 12-18 V, 2.0 A, 50/60 Hz

DENTIS CO. ,LTD

LED dental light, line-powered LED dental light, line-powered LED dental light, line-powered LED dental light, line-powered LED dental light, line-powered LED dental light, line-powered LED dental light, line-powered LED dental light, line-powered LED dental light, line-powered LED dental light, line-powered LED dental light, line-powered LED dental light, line-powered LED dental light, line-powered LED dental light, line-powered LED dental light, line-powered LED dental light, line-powered LED dental light, line-powered
Primary Device ID08800053083867
NIH Device Record Key13b37fb5-3302-4df6-a9cf-e67907f4cdb9
Commercial Distribution StatusIn Commercial Distribution
Brand NameLUVIS-C300 Series
Version Model NumberC300 HEAD
Company DUNS694721181
Company NameDENTIS CO. ,LTD
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 Batchtrue
Serial Numbertrue
Manufacturing Datetrue
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS108800053083867 [Primary]

FDA Product Code

EAZLight, Operating, Dental

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2024-01-31
Device Publish Date2024-01-23

On-Brand Devices [LUVIS-C300 Series]

08800053083898AC 100-240 V 1.5 A, 50-60 Hz
08800053083881AC 100-240 V 1.5 A, 50-60 Hz
08800053083874AC 12-18 V, 2.0 A, 50/60 Hz AC 100-240 V~ 1.5 A, 50-60 Hz
08800053083867AC 12-18 V, 2.0 A, 50/60 Hz

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