VS3 Iridium (785nm) – Visionsense 3DHD and IR Fluorescence Vision System, 110V 145-0011

GUDID 10813040013872

VISIONSENSE LTD.

Endoscope video camera Endoscope video camera Endoscope video camera Endoscope video camera Endoscope video camera Endoscope video camera Endoscope video camera Endoscope video camera Endoscope video camera Endoscope video camera Endoscope video camera Endoscope video camera Endoscope video camera Endoscope video camera Endoscope video camera Endoscope video camera Endoscope video camera Endoscope video camera Endoscope video camera Endoscope video camera Endoscope video camera Endoscope video camera Endoscope video camera Endoscope video camera Endoscope video camera Endoscope video camera Endoscope video camera Endoscope video camera Endoscope video camera Endoscope video camera Endoscope video camera Endoscope video camera Endoscopic video image processing/light source system Endoscopic video image processing/light source system Endoscopic video image processing/light source system Endoscopic video image processing/light source system Endoscopic video image processing/light source system Endoscopic video image processing/light source system Endoscopic video image processing/light source system Endoscopic video image processing/light source system Endoscopic video image processing/light source system Endoscopic video image processing/light source system Endoscopic video image processing/light source system Endoscopic video image processing/light source system Endoscopic video image processing/light source system Endoscopic video image processing/light source system Endoscopic video image processing/light source system Endoscopic video image processing/light source system Endoscopic video image processing/light source system
Primary Device ID10813040013872
NIH Device Record Key0c7cccea-a1d1-4f3f-9507-c240b44b2f96
Commercial Distribution StatusIn Commercial Distribution
Brand NameVS3 Iridium (785nm) – Visionsense 3DHD and IR Fluorescence Vision System, 110V
Version Model NumberVS3-IR
Catalog Number145-0011
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
GS110813040013872 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

GWGEndoscope, Neurological
OWNConfocal Optical Imaging

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2021-02-01
Device Publish Date2021-01-24

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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