E100 series(E1-M, E1-C, E1-W)

GUDID 08800053060813

INPUT : DC 15 V, 1.67 A AC/DC Adaptor : Glob Tek, Inc./GRM41060-33

DENTIS CO. ,LTD

Fixed examination/treatment room light Fixed examination/treatment room light Fixed examination/treatment room light Fixed examination/treatment room light Fixed examination/treatment room light Fixed examination/treatment room light Fixed examination/treatment room light Fixed examination/treatment room light Fixed examination/treatment room light Fixed examination/treatment room light Fixed examination/treatment room light Fixed examination/treatment room light Fixed examination/treatment room light Fixed examination/treatment room light Fixed examination/treatment room light Fixed examination/treatment room light Fixed examination/treatment room light
Primary Device ID08800053060813
NIH Device Record Key9e68f93c-fed6-447d-abd2-01db77bb14b7
Commercial Distribution StatusIn Commercial Distribution
Brand NameE100 series(E1-M, E1-C, E1-W)
Version Model NumberE1-CB
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
GS108800053060813 [Primary]

FDA Product Code

KZFDevice, Medical Examination, Ac Powered

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 [E100 series(E1-M, E1-C, E1-W)]

08800053060837INPUT : DC 15 V, 1.67 A AC/DC Adaptor : Glob Tek, Inc./GRM41060-33
08800053060820INPUT : DC 15 V, 1.67 A AC/DC Adaptor : Glob Tek, Inc./GRM41060-33
08800053060813INPUT : DC 15 V, 1.67 A AC/DC Adaptor : Glob Tek, Inc./GRM41060-33
08800053060806INPUT : DC 15 V, 1.67 A AC/DC Adaptor : Glob Tek, Inc./GRM41060-33
08800053060790INPUT : DC 15 V, 1.67 A AC/DC Adaptor : Glob Tek, Inc./GRM41060-33
08800053060783INPUT : DC 15 V, 1.67 A AC/DC Adaptor : Glob Tek, Inc./GRM41060-33
08800053060776INPUT : DC 15 V, 1.67 A AC/DC Adaptor : Glob Tek, Inc./GRM41060-33
08800053060769INPUT : DC 15 V, 1.67 A AC/DC Adaptor : Glob Tek, Inc./GRM41060-33

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