VISION SCREENING PATCH

GUDID 08500291040195

PATCH, VISION SCREENING, INDIVIDUAL

Fresnel Prism & Lens Company

Eye patch Eye patch Eye patch Eye patch Eye patch Eye patch Eye patch Eye patch Eye patch Eye patch Eye patch Eye patch Eye patch Eye patch Eye patch Eye patch

• Primary Device ID: 08500291040195
• NIH Device Record Key: 643215ee-3300-4d82-801f-2a302f106279
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: VISION SCREENING PATCH
• Version Model Number: IND5110B
• Company DUNS: 789337987
• Company Name: Fresnel Prism & Lens Company
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: true
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: true
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: false
• OTC Over-The-Counter: true

Customer Support Contacts

• Phone: 952-496-0432
• Email: info@fresnelprism.com
• Phone: 952-496-0432
• Email: info@fresnelprism.com
• Phone: 952-496-0432
• Email: info@fresnelprism.com
• Phone: 952-496-0432
• Email: info@fresnelprism.com
• Phone: 952-496-0432
• Email: info@fresnelprism.com
• Phone: 952-496-0432
• Email: info@fresnelprism.com
• Phone: 952-496-0432
• Email: info@fresnelprism.com
• Phone: 952-496-0432
• Email: info@fresnelprism.com
• Phone: 952-496-0432
• Email: info@fresnelprism.com
• Phone: 952-496-0432
• Email: info@fresnelprism.com
• Phone: 952-496-0432
• Email: info@fresnelprism.com
• Phone: 952-496-0432
• Email: info@fresnelprism.com
• Phone: 952-496-0432
• Email: info@fresnelprism.com
• Phone: 952-496-0432
• Email: info@fresnelprism.com
• Phone: 952-496-0432
• Email: info@fresnelprism.com
• Phone: 952-496-0432
• Email: info@fresnelprism.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	08500291040195 [Primary]

FDA Product Code

• HOY: Shield, Eye, Ophthalmic (Including Sunlamp Protective Eyewear And Post-Mydriatic Eyewear)

Sterilization

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

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2021-04-06
• Device Publish Date: 2021-03-29

On-Brand Devices [VISION SCREENING PATCH]

• 08500291040195: PATCH, VISION SCREENING, INDIVIDUAL
• 08500291040201: ROLL, PATCHES, VISION SCREENING
• 00850029104124: PATCH, VISION SCREENING, INDIVIDUAL
• 00850029104452: ROLL, PATCHES, VISION SCREENING