VS3 Iridium Endoscope-IR 10mm, Long, 30°, Standard FOV - Refurbished 153-0072RFB

GUDID 10813040013278

VISIONSENSE LTD.

Endoscope video camera
Primary Device ID10813040013278
NIH Device Record Keye171dd0b-c443-46a9-9ddc-909865f2725c
Commercial Distribution StatusIn Commercial Distribution
Brand NameVS3 Iridium Endoscope-IR 10mm, Long, 30°, Standard FOV - Refurbished
Version Model NumberVS3-IR
Catalog Number153-0072RFB
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
GS110813040013278 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

GWGEndoscope, Neurological

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[10813040013278]

Hydrogen Peroxide;Moist Heat or Steam Sterilization


Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2020-04-15
Device Publish Date2020-04-07

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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