S300 series

GUDID 08800053060745

AC 100-240 V, 50/60 Hz, 61 VA

DENTIS CO. ,LTD

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Primary Device ID08800053060745
NIH Device Record Key40261cef-a009-452a-a8a9-05f8dda6684c
Commercial Distribution StatusIn Commercial Distribution
Brand NameS300 series
Version Model NumberS300-A0000
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 Batchfalse
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
GS108800053060745 [Primary]

FDA Product Code

FTDLamp, Surgical

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 [S300 series]

08800053060752AC 100-240 V, 50/60 Hz, 84 VA
08800053060745AC 100-240 V, 50/60 Hz, 61 VA

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