COVERCLUDE OCCLUSION EYE PATCHES

GUDID 00850029104049

PACKET, REGULAR, COVERCLUDE

Fresnel Prism & Lens Company

Eye patch
Primary Device ID00850029104049
NIH Device Record Key8c12ce3f-06b9-4690-9df0-dffb370ac88f
Commercial Distribution StatusIn Commercial Distribution
Brand NameCOVERCLUDE OCCLUSION EYE PATCHES
Version Model Number011
Company DUNS789337987
Company NameFresnel Prism & Lens Company
Device Count10
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
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
GS100850029104049 [Primary]
GS100850029104483 [Unit of Use]
GS100850029104599 [Package]
Package: [5 Units]
In Commercial Distribution
GS110850029104596 [Package]
Package: [5 Units]
In Commercial Distribution

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 StatusUpdate
Device Record StatusPublished
Public Version Number4
Public Version Date2021-06-02
Device Publish Date2021-03-29

On-Brand Devices [COVERCLUDE OCCLUSION EYE PATCHES]

08500291040065PACKET, JUNIOR, COVERCLUDE
08500291040058PACKET, REGULAR, COVERCLUDE
00850029104056PACKET, JUNIOR, COVERCLUDE
00850029104049PACKET, REGULAR, COVERCLUDE

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