S250 Series(Ceiling, Mobile

GUDID 08800053093644

AC 100-240 V, 50/60 Hz, 61-94VA

DENTIS CO. ,LTD

Operating room light system
Primary Device ID08800053093644
NIH Device Record Key37bd0e55-9f11-4bd5-8aeb-606b47ac1176
Commercial Distribution StatusIn Commercial Distribution
Brand NameS250 Series(Ceiling, Mobile
Version Model NumberS250-20000
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
GS108800053093644 [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 Date2024-11-06
Device Publish Date2024-10-29

Devices Manufactured by DENTIS CO. ,LTD

08800053093743 - S250 Series(Ceiling, Mobile)2024-11-07 AC 100-240V, 50/60HZ, 61-94VA
08800053093644 - S250 Series(Ceiling, Mobile2024-11-06AC 100-240 V, 50/60 Hz, 61-94VA
08800053093644 - S250 Series(Ceiling, Mobile2024-11-06 AC 100-240 V, 50/60 Hz, 61-94VA
08800053093651 - S250 Series(Ceiling, Mobile)2024-11-06 AC 100-240V, 50/60HZ, 61-94VA
08800053093668 - S250 Series(Ceiling, Mobile)2024-11-06 AC 100-240V, 50/60Hz, 61-94VA
08800053093675 - S250 Series(Ceiling, Mobile)2024-11-06 AC 100-240V, 50/60HZ, 61-94VA
08800053093682 - S250 Series(Ceiling, Mobile)2024-11-06 AC 100-240V, 50/60HZ, 61-94VA
08800053093705 - S250 Series(Ceiling, Mobile)2024-11-06 AC 100-240V, 50/60HZ, 61-94VA
08800053093712 - S250 Series(Ceiling, Mobile)2024-11-06 AC 100-240V, 50/60HZ, 61-94VA

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