M310 Series (Ceiling, Mobile)

GUDID 08800053070089

RATING : AC 100-240 V, 50-60 Hz, 133-155 VA

DENTIS CO. ,LTD

Operating room light system Operating room light system Operating room light system Operating room light system Operating room light system Operating room light system Operating room light system Operating room light system Operating room light system Operating room light system Operating room light system Operating room light system Operating room light system Operating room light system Operating room light system Operating room light system Operating room light system
Primary Device ID08800053070089
NIH Device Record Keya6f063c8-4776-42c8-8484-cb29472fd8ec
Commercial Distribution StatusIn Commercial Distribution
Brand NameM310 Series (Ceiling, Mobile)
Version Model NumberM310
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
GS108800053070089 [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

Devices Manufactured by DENTIS CO. ,LTD

08800053091305 - Luvis Chair (LC700C-chair only)2024-04-03 A Dental Chair to provide patient supporting and positioning during dental treatment.
08806169138965 - s-Clean Ratchet Driver2024-04-02 s-Clean Ratchet Driver (DRMDSEL)
08800053082808 - MESHEET0752024-03-13 MESHEET075
08800053082815 - MESHEET075-R2024-03-13
08800053042093 - DENOPS2024-01-31 DC : 3.7 V, 550mh(Battery)
08800053045032 - LUVIS-C600 Series2024-01-31 AC 100-240 V, 50-60 Hz, 30-45 VA
08800053045049 - LUVIS-C600 Series2024-01-31 AC 100-240 V, 50-60 Hz, 30-45 VA
08800053045056 - LUVIS-C600 Series2024-01-31 AC 100-240 V, 50-60 Hz, 30-45 VA

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.