VISION SCREENING PATCH

GUDID 08500291040195

PATCH, VISION SCREENING, INDIVIDUAL

Fresnel Prism & Lens Company

Eye patch
Primary Device ID08500291040195
NIH Device Record Key643215ee-3300-4d82-801f-2a302f106279
Commercial Distribution StatusIn Commercial Distribution
Brand NameVISION SCREENING PATCH
Version Model NumberIND5110B
Company DUNS789337987
Company NameFresnel Prism & Lens Company
Device Count1
DM Exemptfalse
Pre-market Exempttrue
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datefalse
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptionfalse
OTC Over-The-Countertrue

Customer Support Contacts

Phone952-496-0432
Emailinfo@fresnelprism.com
Phone952-496-0432
Emailinfo@fresnelprism.com
Phone952-496-0432
Emailinfo@fresnelprism.com
Phone952-496-0432
Emailinfo@fresnelprism.com
Phone952-496-0432
Emailinfo@fresnelprism.com
Phone952-496-0432
Emailinfo@fresnelprism.com
Phone952-496-0432
Emailinfo@fresnelprism.com
Phone952-496-0432
Emailinfo@fresnelprism.com
Phone952-496-0432
Emailinfo@fresnelprism.com
Phone952-496-0432
Emailinfo@fresnelprism.com
Phone952-496-0432
Emailinfo@fresnelprism.com
Phone952-496-0432
Emailinfo@fresnelprism.com
Phone952-496-0432
Emailinfo@fresnelprism.com
Phone952-496-0432
Emailinfo@fresnelprism.com
Phone952-496-0432
Emailinfo@fresnelprism.com
Phone952-496-0432
Emailinfo@fresnelprism.com

Device Identifiers

Device Issuing AgencyDevice ID
GS108500291040195 [Primary]

FDA Product Code

HOYShield, Eye, Ophthalmic (Including Sunlamp Protective Eyewear And Post-Mydriatic Eyewear)

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2021-04-06
Device Publish Date2021-03-29

On-Brand Devices [VISION SCREENING PATCH]

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

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