VS3 Endoscope 4mm, ETV, 0°, Wide FOV 153-0003

GUDID 18130400103403

VISIONSENSE LTD.

Endoscope video camera

Primary Device ID	18130400103403
NIH Device Record Key	955b87d9-160f-4bc5-a63a-5bb28b8a753a
Commercial Distribution Status	In Commercial Distribution
Brand Name	VS3 Endoscope 4mm, ETV, 0°, Wide FOV
Version Model Number	VS3-ETV
Catalog Number	153-0003
Company DUNS	532199478
Company Name	VISIONSENSE LTD.
Device Count	1
DM Exempt	false
Pre-market Exempt	false
MRI Safety Status	Labeling does not contain MRI Safety Information
Human Cell/Tissue Product	false
Device Kit	false
Device Combination Product	false
Single Use	false
Lot Batch	false
Serial Number	true
Manufacturing Date	true
Expiration Date	false
Donation Id Number	false
Contains Natural Rubber Latex	false
Labeled No Natural Rubber Latex	false
RX Perscription	false
OTC Over-The-Counter	false

Device Identifiers

Device Issuing Agency	Device ID
GS1	18130400103403 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

Premarket Notification: K153548

FDA Product Code

HRX	Arthroscope

Sterilization

Steralize Prior To Use	true
Device Is Sterile	false

[18130400103403]

Moist Heat or Steam Sterilization;Hydrogen Peroxide

[18130400103403]

Moist Heat or Steam Sterilization;Hydrogen Peroxide

[18130400103403]

Moist Heat or Steam Sterilization;Hydrogen Peroxide

[18130400103403]

Moist Heat or Steam Sterilization;Hydrogen Peroxide

[18130400103403]

Moist Heat or Steam Sterilization;Hydrogen Peroxide

[18130400103403]

Moist Heat or Steam Sterilization;Hydrogen Peroxide

[18130400103403]

Moist Heat or Steam Sterilization;Hydrogen Peroxide

[18130400103403]

Moist Heat or Steam Sterilization;Hydrogen Peroxide

[18130400103403]

Moist Heat or Steam Sterilization;Hydrogen Peroxide

[18130400103403]

Moist Heat or Steam Sterilization;Hydrogen Peroxide

[18130400103403]

Moist Heat or Steam Sterilization;Hydrogen Peroxide

[18130400103403]

Moist Heat or Steam Sterilization;Hydrogen Peroxide

[18130400103403]

Moist Heat or Steam Sterilization;Hydrogen Peroxide

[18130400103403]

Moist Heat or Steam Sterilization;Hydrogen Peroxide

[18130400103403]

Moist Heat or Steam Sterilization;Hydrogen Peroxide

[18130400103403]

Moist Heat or Steam Sterilization;Hydrogen Peroxide

[18130400103403]

Moist Heat or Steam Sterilization;Hydrogen Peroxide

[18130400103403]

Moist Heat or Steam Sterilization;Hydrogen Peroxide

[18130400103403]

Moist Heat or Steam Sterilization;Hydrogen Peroxide

[18130400103403]

Moist Heat or Steam Sterilization;Hydrogen Peroxide

[18130400103403]

Moist Heat or Steam Sterilization;Hydrogen Peroxide

[18130400103403]

Moist Heat or Steam Sterilization;Hydrogen Peroxide

[18130400103403]

Moist Heat or Steam Sterilization;Hydrogen Peroxide

[18130400103403]

Moist Heat or Steam Sterilization;Hydrogen Peroxide

[18130400103403]

Moist Heat or Steam Sterilization;Hydrogen Peroxide

[18130400103403]

Moist Heat or Steam Sterilization;Hydrogen Peroxide

[18130400103403]

Moist Heat or Steam Sterilization;Hydrogen Peroxide

[18130400103403]

Moist Heat or Steam Sterilization;Hydrogen Peroxide

[18130400103403]

Moist Heat or Steam Sterilization;Hydrogen Peroxide

[18130400103403]

Moist Heat or Steam Sterilization;Hydrogen Peroxide

[18130400103403]

Moist Heat or Steam Sterilization;Hydrogen Peroxide

[18130400103403]

Moist Heat or Steam Sterilization;Hydrogen Peroxide

[18130400103403]

Moist Heat or Steam Sterilization;Hydrogen Peroxide

[18130400103403]

Moist Heat or Steam Sterilization;Hydrogen Peroxide

[18130400103403]

Moist Heat or Steam Sterilization;Hydrogen Peroxide

[18130400103403]

Moist Heat or Steam Sterilization;Hydrogen Peroxide

[18130400103403]

Moist Heat or Steam Sterilization;Hydrogen Peroxide

[18130400103403]

Moist Heat or Steam Sterilization;Hydrogen Peroxide

[18130400103403]

Moist Heat or Steam Sterilization;Hydrogen Peroxide

[18130400103403]

Moist Heat or Steam Sterilization;Hydrogen Peroxide

[18130400103403]

Moist Heat or Steam Sterilization;Hydrogen Peroxide

[18130400103403]

Moist Heat or Steam Sterilization;Hydrogen Peroxide

[18130400103403]

Moist Heat or Steam Sterilization;Hydrogen Peroxide

[18130400103403]

Moist Heat or Steam Sterilization;Hydrogen Peroxide

[18130400103403]

Moist Heat or Steam Sterilization;Hydrogen Peroxide

Device Entry Metadata

Public Version Status	Update
Device Record Status	Published
Public Version Number	3
Public Version Date	2018-07-06
Device Publish Date	2016-09-23

Devices Manufactured by VISIONSENSE LTD.

10884521815926 - VS3 Iridium	2024-11-19 VS3 Iridium - Fluorescence High Definition Camera, 785nm (Camera-IR)
10884521816695 - VS3-IR	2024-11-19 153-0054 VS3 IR ENDOSCOPE 5MM 30DEG
10884521816701 - VS3-IR	2024-11-19 153-0055 VS3 IR ENDOSCOPE 5MM 0DEG
10884521816718 - VS3-IR	2024-11-19 153-0074 VS3 IR ENDOSCOPE 10MM 30DEG
10884521816725 - VS3-IR	2024-11-19 153-0075 VS3 IR ENDOSCOPE 10MM 0DEG
10884521821187 - VS3-NE	2024-11-19 VS3 Visionsense Camera Control Unit (CCU)
10884521844681 - VS3 Iridium	2024-11-19 VS3 Iridium - Miniature Microscope, 785nm (MMS-IR)
10884521844698 - VS3 Iridium	2024-11-19 VS3 Iridium - Laser Light Source, 785nm (LLS)

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.