VS3 Iridium Endoscope-IR 10mm, Long, 0°, Standard 153-0073

GUDID 18130400103632

VISIONSENSE LTD.

Endoscope video camera
Primary Device ID18130400103632
NIH Device Record Keyd8ce0acf-d536-402e-ba9e-07538ecf4a83
Commercial Distribution StatusIn Commercial Distribution
Brand NameVS3 Iridium Endoscope-IR 10mm, Long, 0°, Standard
Version Model NumberVS3-IR
Catalog Number153-0073
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
GS118130400103632 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

HRXArthroscope

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[18130400103632]

Moist Heat or Steam Sterilization;Hydrogen Peroxide


[18130400103632]

Moist Heat or Steam Sterilization;Hydrogen Peroxide


[18130400103632]

Moist Heat or Steam Sterilization;Hydrogen Peroxide


[18130400103632]

Moist Heat or Steam Sterilization;Hydrogen Peroxide


[18130400103632]

Moist Heat or Steam Sterilization;Hydrogen Peroxide


[18130400103632]

Moist Heat or Steam Sterilization;Hydrogen Peroxide


[18130400103632]

Moist Heat or Steam Sterilization;Hydrogen Peroxide


[18130400103632]

Moist Heat or Steam Sterilization;Hydrogen Peroxide


[18130400103632]

Moist Heat or Steam Sterilization;Hydrogen Peroxide


[18130400103632]

Moist Heat or Steam Sterilization;Hydrogen Peroxide


[18130400103632]

Moist Heat or Steam Sterilization;Hydrogen Peroxide


[18130400103632]

Moist Heat or Steam Sterilization;Hydrogen Peroxide


[18130400103632]

Moist Heat or Steam Sterilization;Hydrogen Peroxide


[18130400103632]

Moist Heat or Steam Sterilization;Hydrogen Peroxide


[18130400103632]

Moist Heat or Steam Sterilization;Hydrogen Peroxide


[18130400103632]

Moist Heat or Steam Sterilization;Hydrogen Peroxide


[18130400103632]

Moist Heat or Steam Sterilization;Hydrogen Peroxide


[18130400103632]

Moist Heat or Steam Sterilization;Hydrogen Peroxide


[18130400103632]

Moist Heat or Steam Sterilization;Hydrogen Peroxide


[18130400103632]

Moist Heat or Steam Sterilization;Hydrogen Peroxide


[18130400103632]

Moist Heat or Steam Sterilization;Hydrogen Peroxide


[18130400103632]

Moist Heat or Steam Sterilization;Hydrogen Peroxide


[18130400103632]

Moist Heat or Steam Sterilization;Hydrogen Peroxide


[18130400103632]

Moist Heat or Steam Sterilization;Hydrogen Peroxide


[18130400103632]

Moist Heat or Steam Sterilization;Hydrogen Peroxide


[18130400103632]

Moist Heat or Steam Sterilization;Hydrogen Peroxide


[18130400103632]

Moist Heat or Steam Sterilization;Hydrogen Peroxide


[18130400103632]

Moist Heat or Steam Sterilization;Hydrogen Peroxide


[18130400103632]

Moist Heat or Steam Sterilization;Hydrogen Peroxide


[18130400103632]

Moist Heat or Steam Sterilization;Hydrogen Peroxide


Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number3
Public Version Date2018-07-06
Device Publish Date2016-11-23

Devices Manufactured by VISIONSENSE LTD.

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10884521816701 - VS3-IR2024-11-19 153-0055 VS3 IR ENDOSCOPE 5MM 0DEG
10884521816718 - VS3-IR2024-11-19 153-0074 VS3 IR ENDOSCOPE 10MM 30DEG
10884521816725 - VS3-IR2024-11-19 153-0075 VS3 IR ENDOSCOPE 10MM 0DEG
10884521821187 - VS3-NE2024-11-19 VS3 Visionsense Camera Control Unit (CCU)
10884521844681 - VS3 Iridium2024-11-19 VS3 Iridium - Miniature Microscope, 785nm (MMS-IR)
10884521844698 - VS3 Iridium2024-11-19 VS3 Iridium - Laser Light Source, 785nm (LLS)

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