COVERCLUDE OCCLUSION EYE PATCHES

GUDID 08500291040065

PACKET, JUNIOR, COVERCLUDE

Fresnel Prism & Lens Company

Eye patch
Primary Device ID08500291040065
NIH Device Record Key5aa89223-0f06-49e9-ab9f-3ad24c856edb
Commercial Distribution StatusIn Commercial Distribution
Brand NameCOVERCLUDE OCCLUSION EYE PATCHES
Version Model Number012
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
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
GS100850029104056 [Primary]
GS100850029104490 [Unit of Use]
GS100850029104605 [Package]
Contains: 00850029104056
Package: PACKETS of 10 [5 Units]
In Commercial Distribution
GS108500291040065 [Package]
Contains: 08500291040126
Package: PACKETS of 10 [5 Units]
In Commercial Distribution
GS108500291040126 [Primary]
GS108500291040577 [Unit of Use]

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 [COVERCLUDE OCCLUSION EYE PATCHES]

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