VS3 Iridium - Fluorescence High Definition Camera 174-0051

GUDID 18130400103472

VISIONSENSE LTD.

Endoscope video camera Endoscope video camera
Primary Device ID18130400103472
NIH Device Record Key49916755-a72c-4b71-a92e-91ce5d255c30
Commercial Distribution StatusIn Commercial Distribution
Brand NameVS3 Iridium - Fluorescence High Definition Camera
Version Model NumberVS3-IR
Catalog Number174-0051
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
GS118130400103472 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

HRXArthroscope

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[18130400103472]

Hydrogen Peroxide


[18130400103472]

Hydrogen Peroxide


Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number3
Public Version Date2018-07-06
Device Publish Date2016-09-23

Devices Manufactured by VISIONSENSE LTD.

10884521842489 - VS3 Visionsense Camera Control Unit (CCU)2023-03-21
10813040013636 - VS3 Iridium 2022-07-13 VS3 Iridium Endoscope-IR 10mm, Long, 0°, Standard FOV
10813040013858 - VS3 Iridium 2022-07-13 VS3 Iridium Endoscope-IR 5.5 mm, 0°, Standard View
10884521833173 - VS3 Visionsense Camera Control Unit (CCU)2022-05-18
10884521834644 - VS3 Iridium - Laser Light Source (LLS)2022-05-17
10884521834651 - VS3 Iridium - Laser Light Source, 785nm (LLS)2022-05-17
10813040013988 - VS3 Iridium - Fluorescence High Definition Camera (Camera-IR)2021-08-18
10813040013995 - VS3 Iridium - Fluorescence High Definition Camera, 785nm (Camera-IR)2021-08-18

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