Visionix VSN5800NB

GUDID 04580606431522

CLINICAL UNIT SET

RIGHT MFG. CO., LTD.

Ophthalmic examination slit lamp
Primary Device ID04580606431522
NIH Device Record Key5b36113e-2075-485a-a2d4-efd7eab16953
Commercial Distribution StatusIn Commercial Distribution
Brand NameVisionix
Version Model NumberMW50D
Catalog NumberVSN5800NB
Company DUNS713383495
Company NameRIGHT MFG. CO., LTD.
Device Count1
DM Exemptfalse
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

Device Dimensions

Width350 Millimeter
Depth387 Millimeter
Height678.5 Millimeter
Weight14 Kilogram

Operating and Storage Conditions

Storage Environment TemperatureBetween -10 Degrees Celsius and 55 Degrees Celsius
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment Atmospheric PressureBetween 70 KiloPascal and 106 KiloPascal
Handling Environment TemperatureBetween 10 Degrees Celsius and 40 Degrees Celsius
Handling Environment HumidityBetween 30 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Handling Environment Atmospheric PressureBetween 70 KiloPascal and 106 KiloPascal

Device Identifiers

Device Issuing AgencyDevice ID
GS104580606431522 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

HJOBiomicroscope, Slit-Lamp, Ac-Powered

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2023-01-13
Device Publish Date2023-01-05

On-Brand Devices [Visionix ]

04580606431850Bear Chart SET
04580606431843Fireworks Chart SET
04580606431836Tulip Chart SET
04580606431768Bear Chart SET
04580606431751Fireworks Chart SET
04580606431744Tulip Chart SET
04580606431652Tulip Chart SET
04580606431584DIGITAL PHOTO UNIT SET
04580606431553DIGITAL PHOTO UNIT SET
04580606431522CLINICAL UNIT SET
04580606431492CLINICAL UNIT SET

Trademark Results [Visionix]

Mark Image

Registration | Serial
Company
Trademark
Application Date
VISIONIX
VISIONIX
97162724 not registered Live/Pending
Luneau Technology Operations
2021-12-08
VISIONIX
VISIONIX
85150220 4015109 Live/Registered
VISIONIX LTD.
2010-10-12
VISIONIX
VISIONIX
77374238 4077385 Live/Registered
THALES DEFENSE & SECURITY, INC.
2008-01-17
VISIONIX
VISIONIX
75741616 2410211 Dead/Cancelled
VISIONIX LTD.
1999-06-25

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