MACHIDA

GUDID 04580137730217

MACHIDA ENDOSCOPE CO.,LTD.

Flexible fibreoptic nasopharyngoscope
Primary Device ID04580137730217
NIH Device Record Keyfaee473e-52bd-4c16-97bc-69351f9f93ea
Commercial Distribution StatusIn Commercial Distribution
Brand NameMACHIDA
Version Model NumberENT-4L
Company DUNS690662549
Company NameMACHIDA ENDOSCOPE CO.,LTD.
Device Count1
DM Exempttrue
Pre-market Exemptfalse
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 Perscriptionfalse
OTC Over-The-Counterfalse

Operating and Storage Conditions

Storage Environment TemperatureBetween 10 Degrees Celsius and 40 Degrees Celsius
Storage Environment HumidityBetween 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
Storage Environment Atmospheric PressureBetween 700 millibar and 1060 millibar
Handling Environment TemperatureBetween 10 Degrees Celsius and 40 Degrees Celsius
Handling Environment HumidityBetween 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
Handling Environment Atmospheric PressureBetween 700 millibar and 1060 millibar

Device Identifiers

Device Issuing AgencyDevice ID
GS104580137730217 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

EQNLaryngoscope, Nasopharyngoscope

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number3
Public Version Date2018-07-06
Device Publish Date2016-09-10

On-Brand Devices [MACHIDA]

04580137732518ENT-2L
04580137732501ENT-3C
04580137730217ENT-4L
04580137730200ENT-3L
04580137733041VSP-2000
04580137733034ENT-30VE
04580137730279LY-CS30

Trademark Results [MACHIDA]

Mark Image

Registration | Serial
Company
Trademark
Application Date
MACHIDA
MACHIDA
86703985 not registered Dead/Abandoned
Machida Incorporated
2015-07-24
MACHIDA
MACHIDA
72417869 0971439 Live/Registered
KABUSHIKI KAISHA MACHIDA SEISAKUSHO
1972-03-09

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