ESSILOR SL450H

GUDID 03615020000335

Slit lamp microscopes are used to observe the disease of the anterior structures and tissue damage of eyes

ESSILOR INTERNATIONAL

Ophthalmic slit lamp, examination

• Primary Device ID: 03615020000335
• NIH Device Record Key: cec4f3e4-23d6-4837-a9c0-a228dbd7c5c7
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: ESSILOR SL450H
• Version Model Number: SL450H
• Company DUNS: 277373213
• Company Name: ESSILOR INTERNATIONAL
• 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: true
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: +33172947322
• Email: qualite.instruments@essilor.fr
• Phone: +33172947322
• Email: qualite.instruments@essilor.fr
• Phone: +33172947322
• Email: qualite.instruments@essilor.fr
• Phone: +33172947322
• Email: qualite.instruments@essilor.fr
• Phone: +33172947322
• Email: qualite.instruments@essilor.fr
• Phone: +33172947322
• Email: qualite.instruments@essilor.fr
• Phone: +33172947322
• Email: qualite.instruments@essilor.fr
• Phone: +33172947322
• Email: qualite.instruments@essilor.fr
• Phone: +33172947322
• Email: qualite.instruments@essilor.fr
• Phone: +33172947322
• Email: qualite.instruments@essilor.fr
• Phone: +33172947322
• Email: qualite.instruments@essilor.fr
• Phone: +33172947322
• Email: qualite.instruments@essilor.fr
• Phone: +33172947322
• Email: qualite.instruments@essilor.fr
• Phone: +33172947322
• Email: qualite.instruments@essilor.fr
• Phone: +33172947322
• Email: qualite.instruments@essilor.fr
• Phone: +33172947322
• Email: qualite.instruments@essilor.fr
• Phone: +33172947322
• Email: qualite.instruments@essilor.fr
• Phone: +33172947322
• Email: qualite.instruments@essilor.fr
• Phone: +33172947322
• Email: qualite.instruments@essilor.fr
• Phone: +33172947322
• Email: qualite.instruments@essilor.fr
• Phone: +33172947322
• Email: qualite.instruments@essilor.fr
• Phone: +33172947322
• Email: qualite.instruments@essilor.fr
• Phone: +33172947322
• Email: qualite.instruments@essilor.fr
• Phone: +33172947322
• Email: qualite.instruments@essilor.fr
• Phone: +33172947322
• Email: qualite.instruments@essilor.fr
• Phone: +33172947322
• Email: qualite.instruments@essilor.fr
• Phone: +33172947322
• Email: qualite.instruments@essilor.fr
• Phone: +33172947322
• Email: qualite.instruments@essilor.fr
• Phone: +33172947322
• Email: qualite.instruments@essilor.fr
• Phone: +33172947322
• Email: qualite.instruments@essilor.fr
• Phone: +33172947322
• Email: qualite.instruments@essilor.fr
• Phone: +33172947322
• Email: qualite.instruments@essilor.fr

Operating and Storage Conditions

• Storage Environment Temperature: Between -40 Degrees Celsius and 55 Degrees Celsius
• Storage Environment Humidity: Between 0 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Storage Environment Atmospheric Pressure: Between 80 KiloPascal and 106 KiloPascal
• Handling Environment Temperature: Between -40 Degrees Celsius and 55 Degrees Celsius
• Handling Environment Humidity: Between 0 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Handling Environment Atmospheric Pressure: Between 80 KiloPascal and 106 KiloPascal
• Storage Environment Temperature: Between -40 Degrees Celsius and 55 Degrees Celsius
• Storage Environment Humidity: Between 0 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Storage Environment Atmospheric Pressure: Between 80 KiloPascal and 106 KiloPascal
• Handling Environment Temperature: Between -40 Degrees Celsius and 55 Degrees Celsius
• Handling Environment Humidity: Between 0 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Handling Environment Atmospheric Pressure: Between 80 KiloPascal and 106 KiloPascal
• Storage Environment Temperature: Between -40 Degrees Celsius and 55 Degrees Celsius
• Storage Environment Humidity: Between 0 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Storage Environment Atmospheric Pressure: Between 80 KiloPascal and 106 KiloPascal
• Handling Environment Temperature: Between -40 Degrees Celsius and 55 Degrees Celsius
• Handling Environment Humidity: Between 0 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Handling Environment Atmospheric Pressure: Between 80 KiloPascal and 106 KiloPascal
• Storage Environment Temperature: Between -40 Degrees Celsius and 55 Degrees Celsius
• Storage Environment Humidity: Between 0 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Storage Environment Atmospheric Pressure: Between 80 KiloPascal and 106 KiloPascal
• Handling Environment Temperature: Between -40 Degrees Celsius and 55 Degrees Celsius
• Handling Environment Humidity: Between 0 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Handling Environment Atmospheric Pressure: Between 80 KiloPascal and 106 KiloPascal
• Storage Environment Temperature: Between -40 Degrees Celsius and 55 Degrees Celsius
• Storage Environment Humidity: Between 0 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Storage Environment Atmospheric Pressure: Between 80 KiloPascal and 106 KiloPascal
• Handling Environment Temperature: Between -40 Degrees Celsius and 55 Degrees Celsius
• Handling Environment Humidity: Between 0 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Handling Environment Atmospheric Pressure: Between 80 KiloPascal and 106 KiloPascal
• Storage Environment Temperature: Between -40 Degrees Celsius and 55 Degrees Celsius
• Storage Environment Humidity: Between 0 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Storage Environment Atmospheric Pressure: Between 80 KiloPascal and 106 KiloPascal
• Handling Environment Temperature: Between -40 Degrees Celsius and 55 Degrees Celsius
• Handling Environment Humidity: Between 0 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Handling Environment Atmospheric Pressure: Between 80 KiloPascal and 106 KiloPascal
• Storage Environment Temperature: Between -40 Degrees Celsius and 55 Degrees Celsius
• Storage Environment Humidity: Between 0 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Storage Environment Atmospheric Pressure: Between 80 KiloPascal and 106 KiloPascal
• Handling Environment Temperature: Between -40 Degrees Celsius and 55 Degrees Celsius
• Handling Environment Humidity: Between 0 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Handling Environment Atmospheric Pressure: Between 80 KiloPascal and 106 KiloPascal
• Storage Environment Temperature: Between -40 Degrees Celsius and 55 Degrees Celsius
• Storage Environment Humidity: Between 0 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Storage Environment Atmospheric Pressure: Between 80 KiloPascal and 106 KiloPascal
• Handling Environment Temperature: Between -40 Degrees Celsius and 55 Degrees Celsius
• Handling Environment Humidity: Between 0 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Handling Environment Atmospheric Pressure: Between 80 KiloPascal and 106 KiloPascal
• Storage Environment Temperature: Between -40 Degrees Celsius and 55 Degrees Celsius
• Storage Environment Humidity: Between 0 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Storage Environment Atmospheric Pressure: Between 80 KiloPascal and 106 KiloPascal
• Handling Environment Temperature: Between -40 Degrees Celsius and 55 Degrees Celsius
• Handling Environment Humidity: Between 0 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Handling Environment Atmospheric Pressure: Between 80 KiloPascal and 106 KiloPascal
• Storage Environment Temperature: Between -40 Degrees Celsius and 55 Degrees Celsius
• Storage Environment Humidity: Between 0 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Storage Environment Atmospheric Pressure: Between 80 KiloPascal and 106 KiloPascal
• Handling Environment Temperature: Between -40 Degrees Celsius and 55 Degrees Celsius
• Handling Environment Humidity: Between 0 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Handling Environment Atmospheric Pressure: Between 80 KiloPascal and 106 KiloPascal
• Storage Environment Temperature: Between -40 Degrees Celsius and 55 Degrees Celsius
• Storage Environment Humidity: Between 0 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Storage Environment Atmospheric Pressure: Between 80 KiloPascal and 106 KiloPascal
• Handling Environment Temperature: Between -40 Degrees Celsius and 55 Degrees Celsius
• Handling Environment Humidity: Between 0 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Handling Environment Atmospheric Pressure: Between 80 KiloPascal and 106 KiloPascal
• Storage Environment Temperature: Between -40 Degrees Celsius and 55 Degrees Celsius
• Storage Environment Humidity: Between 0 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Storage Environment Atmospheric Pressure: Between 80 KiloPascal and 106 KiloPascal
• Handling Environment Temperature: Between -40 Degrees Celsius and 55 Degrees Celsius
• Handling Environment Humidity: Between 0 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Handling Environment Atmospheric Pressure: Between 80 KiloPascal and 106 KiloPascal
• Storage Environment Temperature: Between -40 Degrees Celsius and 55 Degrees Celsius
• Storage Environment Humidity: Between 0 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Storage Environment Atmospheric Pressure: Between 80 KiloPascal and 106 KiloPascal
• Handling Environment Temperature: Between -40 Degrees Celsius and 55 Degrees Celsius
• Handling Environment Humidity: Between 0 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Handling Environment Atmospheric Pressure: Between 80 KiloPascal and 106 KiloPascal
• Storage Environment Temperature: Between -40 Degrees Celsius and 55 Degrees Celsius
• Storage Environment Humidity: Between 0 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Storage Environment Atmospheric Pressure: Between 80 KiloPascal and 106 KiloPascal
• Handling Environment Temperature: Between -40 Degrees Celsius and 55 Degrees Celsius
• Handling Environment Humidity: Between 0 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Handling Environment Atmospheric Pressure: Between 80 KiloPascal and 106 KiloPascal
• Storage Environment Temperature: Between -40 Degrees Celsius and 55 Degrees Celsius
• Storage Environment Humidity: Between 0 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Storage Environment Atmospheric Pressure: Between 80 KiloPascal and 106 KiloPascal
• Handling Environment Temperature: Between -40 Degrees Celsius and 55 Degrees Celsius
• Handling Environment Humidity: Between 0 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Handling Environment Atmospheric Pressure: Between 80 KiloPascal and 106 KiloPascal
• Storage Environment Temperature: Between -40 Degrees Celsius and 55 Degrees Celsius
• Storage Environment Humidity: Between 0 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Storage Environment Atmospheric Pressure: Between 80 KiloPascal and 106 KiloPascal
• Handling Environment Temperature: Between -40 Degrees Celsius and 55 Degrees Celsius
• Handling Environment Humidity: Between 0 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Handling Environment Atmospheric Pressure: Between 80 KiloPascal and 106 KiloPascal
• Storage Environment Temperature: Between -40 Degrees Celsius and 55 Degrees Celsius
• Storage Environment Humidity: Between 0 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Storage Environment Atmospheric Pressure: Between 80 KiloPascal and 106 KiloPascal
• Handling Environment Temperature: Between -40 Degrees Celsius and 55 Degrees Celsius
• Handling Environment Humidity: Between 0 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Handling Environment Atmospheric Pressure: Between 80 KiloPascal and 106 KiloPascal
• Storage Environment Temperature: Between -40 Degrees Celsius and 55 Degrees Celsius
• Storage Environment Humidity: Between 0 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Storage Environment Atmospheric Pressure: Between 80 KiloPascal and 106 KiloPascal
• Handling Environment Temperature: Between -40 Degrees Celsius and 55 Degrees Celsius
• Handling Environment Humidity: Between 0 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Handling Environment Atmospheric Pressure: Between 80 KiloPascal and 106 KiloPascal
• Storage Environment Temperature: Between -40 Degrees Celsius and 55 Degrees Celsius
• Storage Environment Humidity: Between 0 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Storage Environment Atmospheric Pressure: Between 80 KiloPascal and 106 KiloPascal
• Handling Environment Temperature: Between -40 Degrees Celsius and 55 Degrees Celsius
• Handling Environment Humidity: Between 0 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Handling Environment Atmospheric Pressure: Between 80 KiloPascal and 106 KiloPascal
• Storage Environment Temperature: Between -40 Degrees Celsius and 55 Degrees Celsius
• Storage Environment Humidity: Between 0 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Storage Environment Atmospheric Pressure: Between 80 KiloPascal and 106 KiloPascal
• Handling Environment Temperature: Between -40 Degrees Celsius and 55 Degrees Celsius
• Handling Environment Humidity: Between 0 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Handling Environment Atmospheric Pressure: Between 80 KiloPascal and 106 KiloPascal
• Storage Environment Temperature: Between -40 Degrees Celsius and 55 Degrees Celsius
• Storage Environment Humidity: Between 0 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Storage Environment Atmospheric Pressure: Between 80 KiloPascal and 106 KiloPascal
• Handling Environment Temperature: Between -40 Degrees Celsius and 55 Degrees Celsius
• Handling Environment Humidity: Between 0 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Handling Environment Atmospheric Pressure: Between 80 KiloPascal and 106 KiloPascal
• Storage Environment Temperature: Between -40 Degrees Celsius and 55 Degrees Celsius
• Storage Environment Humidity: Between 0 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Storage Environment Atmospheric Pressure: Between 80 KiloPascal and 106 KiloPascal
• Handling Environment Temperature: Between -40 Degrees Celsius and 55 Degrees Celsius
• Handling Environment Humidity: Between 0 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Handling Environment Atmospheric Pressure: Between 80 KiloPascal and 106 KiloPascal
• Storage Environment Temperature: Between -40 Degrees Celsius and 55 Degrees Celsius
• Storage Environment Humidity: Between 0 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Storage Environment Atmospheric Pressure: Between 80 KiloPascal and 106 KiloPascal
• Handling Environment Temperature: Between -40 Degrees Celsius and 55 Degrees Celsius
• Handling Environment Humidity: Between 0 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Handling Environment Atmospheric Pressure: Between 80 KiloPascal and 106 KiloPascal
• Storage Environment Temperature: Between -40 Degrees Celsius and 55 Degrees Celsius
• Storage Environment Humidity: Between 0 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Storage Environment Atmospheric Pressure: Between 80 KiloPascal and 106 KiloPascal
• Handling Environment Temperature: Between -40 Degrees Celsius and 55 Degrees Celsius
• Handling Environment Humidity: Between 0 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Handling Environment Atmospheric Pressure: Between 80 KiloPascal and 106 KiloPascal
• Storage Environment Temperature: Between -40 Degrees Celsius and 55 Degrees Celsius
• Storage Environment Humidity: Between 0 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Storage Environment Atmospheric Pressure: Between 80 KiloPascal and 106 KiloPascal
• Handling Environment Temperature: Between -40 Degrees Celsius and 55 Degrees Celsius
• Handling Environment Humidity: Between 0 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Handling Environment Atmospheric Pressure: Between 80 KiloPascal and 106 KiloPascal
• Storage Environment Temperature: Between -40 Degrees Celsius and 55 Degrees Celsius
• Storage Environment Humidity: Between 0 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Storage Environment Atmospheric Pressure: Between 80 KiloPascal and 106 KiloPascal
• Handling Environment Temperature: Between -40 Degrees Celsius and 55 Degrees Celsius
• Handling Environment Humidity: Between 0 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Handling Environment Atmospheric Pressure: Between 80 KiloPascal and 106 KiloPascal
• Storage Environment Temperature: Between -40 Degrees Celsius and 55 Degrees Celsius
• Storage Environment Humidity: Between 0 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Storage Environment Atmospheric Pressure: Between 80 KiloPascal and 106 KiloPascal
• Handling Environment Temperature: Between -40 Degrees Celsius and 55 Degrees Celsius
• Handling Environment Humidity: Between 0 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Handling Environment Atmospheric Pressure: Between 80 KiloPascal and 106 KiloPascal
• Storage Environment Temperature: Between -40 Degrees Celsius and 55 Degrees Celsius
• Storage Environment Humidity: Between 0 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Storage Environment Atmospheric Pressure: Between 80 KiloPascal and 106 KiloPascal
• Handling Environment Temperature: Between -40 Degrees Celsius and 55 Degrees Celsius
• Handling Environment Humidity: Between 0 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Handling Environment Atmospheric Pressure: Between 80 KiloPascal and 106 KiloPascal
• Storage Environment Temperature: Between -40 Degrees Celsius and 55 Degrees Celsius
• Storage Environment Humidity: Between 0 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Storage Environment Atmospheric Pressure: Between 80 KiloPascal and 106 KiloPascal
• Handling Environment Temperature: Between -40 Degrees Celsius and 55 Degrees Celsius
• Handling Environment Humidity: Between 0 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Handling Environment Atmospheric Pressure: Between 80 KiloPascal and 106 KiloPascal
• Storage Environment Temperature: Between -40 Degrees Celsius and 55 Degrees Celsius
• Storage Environment Humidity: Between 0 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Storage Environment Atmospheric Pressure: Between 80 KiloPascal and 106 KiloPascal
• Handling Environment Temperature: Between -40 Degrees Celsius and 55 Degrees Celsius
• Handling Environment Humidity: Between 0 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Handling Environment Atmospheric Pressure: Between 80 KiloPascal and 106 KiloPascal
• Storage Environment Temperature: Between -40 Degrees Celsius and 55 Degrees Celsius
• Storage Environment Humidity: Between 0 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Storage Environment Atmospheric Pressure: Between 80 KiloPascal and 106 KiloPascal
• Handling Environment Temperature: Between -40 Degrees Celsius and 55 Degrees Celsius
• Handling Environment Humidity: Between 0 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Handling Environment Atmospheric Pressure: Between 80 KiloPascal and 106 KiloPascal
• Storage Environment Temperature: Between -40 Degrees Celsius and 55 Degrees Celsius
• Storage Environment Humidity: Between 0 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Storage Environment Atmospheric Pressure: Between 80 KiloPascal and 106 KiloPascal
• Handling Environment Temperature: Between -40 Degrees Celsius and 55 Degrees Celsius
• Handling Environment Humidity: Between 0 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Handling Environment Atmospheric Pressure: Between 80 KiloPascal and 106 KiloPascal

Device Identifiers

Device Issuing Agency	Device ID
GS1	03615020000335 [Primary]

FDA Product Code

• HJO: Biomicroscope, Slit-Lamp, Ac-Powered

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2022-04-08
• Device Publish Date: 2016-09-23

Devices Manufactured by ESSILOR INTERNATIONAL

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• 03615020000120 - ALM700: 2023-10-11 This device aims to take the measurements of SPH, CYL, AXIS, prism refractive power and optical axis coordinate of unprocessed l
• 03615020000236 - ALM800: 2023-10-11 This device aims to take the measurements of SPH, CYL, AXIS, prism refractive power and optical axis coordinate of unprocessed l
• 03615020000670 - Vision-C 600: 2023-10-06 Vision-C 600 (VRS001) is a visual chart system, stand-alone type, which displays broad range of charts, based on LCD panel.
• 03615020000427 - Vision-R 800: 2023-09-19 Vision-R 800 is intended to perform a subjective assessment of ametropia or visual function capability
• 03615020000663 - Vision-R 700: 2023-09-19 Vision-R 700 is intended to perform a subjective assessment of ametropia or visual function capability
• 03615020000687 - Vision-S 700: 2023-09-19 Vision-S 700 is a Compact Refraction System used to determine the refractive error and binocular
• 03615020000694 - Vision-R 800: 2023-09-19 Vision-R 800 is intended to perform a subjective assessment of ametropia or visual function capability