Lamp Module For LS300 Xenon Lightsource 560-6478

GUDID 10813040013759

VISIONSENSE LTD.

Endoscope video camera
Primary Device ID10813040013759
NIH Device Record Key873f9d52-a5e4-461e-a41b-98d4a4d0b940
Commercial Distribution StatusIn Commercial Distribution
Brand NameLamp Module For LS300 Xenon Lightsource
Version Model NumberVS3-IR
Catalog Number560-6478
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
GS110813040013759 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

HRXArthroscope

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number2
Public Version Date2019-11-26
Device Publish Date2019-11-05

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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