VS3 Iridium - Fluorescence High Definition Camera, 785nm (Camera-IR) 175-0051

GUDID 10813040013995

VISIONSENSE LTD.

Endoscope video camera
Primary Device ID10813040013995
NIH Device Record Key629c34d1-ce1c-4629-921b-16fd02003676
Commercial Distribution StatusIn Commercial Distribution
Brand NameVS3 Iridium - Fluorescence High Definition Camera, 785nm (Camera-IR)
Version Model NumberVS3-IR
Catalog Number175-0051
Company DUNS532199478
Company NameVISIONSENSE 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 Identifiers

Device Issuing AgencyDevice ID
GS110813040013995 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

GWGEndoscope, Neurological
OWNConfocal Optical Imaging

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[10813040013995]

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[10813040013995]

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[10813040013995]

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[10813040013995]

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[10813040013995]

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[10813040013995]

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[10813040013995]

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[10813040013995]

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[10813040013995]

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[10813040013995]

Hydrogen Peroxide


Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2021-08-18
Device Publish Date2021-08-10

On-Brand Devices [VS3 Iridium - Fluorescence High Definition Camera, 785nm (Camera-IR)]

10813040013995VS3-IR
10813040013704VS3-IR

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