Sharn Inc S2020

GUDID 00811571030866

EyeGard

CLEAR IMAGE DEVICES LLC

Eye patch
Primary Device ID00811571030866
NIH Device Record Key2424ba98-74d6-4311-9823-a67b9f010100
Commercial Distribution StatusIn Commercial Distribution
Brand NameSharn Inc
Version Model NumberS2020
Catalog NumberS2020
Company DUNS115272845
Company NameCLEAR IMAGE DEVICES LLC
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 Datetrue
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latextrue
RX Perscriptionfalse
OTC Over-The-Counterfalse

Customer Support Contacts

Phone616-871-3247
Emailregulatoryaffairs@ascentbrandsinc.com
Phone616-871-3247
Emailregulatoryaffairs@ascentbrandsinc.com
Phone616-871-3247
Emailregulatoryaffairs@ascentbrandsinc.com
Phone616-871-3247
Emailregulatoryaffairs@ascentbrandsinc.com
Phone616-871-3247
Emailregulatoryaffairs@ascentbrandsinc.com
Phone616-871-3247
Emailregulatoryaffairs@ascentbrandsinc.com
Phone616-871-3247
Emailregulatoryaffairs@ascentbrandsinc.com
Phone616-871-3247
Emailregulatoryaffairs@ascentbrandsinc.com
Phone616-871-3247
Emailregulatoryaffairs@ascentbrandsinc.com

Device Identifiers

Device Issuing AgencyDevice ID
GS100811571030866 [Primary]
GS100817518022109 [Previous]

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 Date2021-08-30
Device Publish Date2021-08-20

On-Brand Devices [Sharn Inc]

00811571030880EyeGard Pediatric
00811571030873EyeGard Sensitive
00811571030866EyeGard
00811571030859EyeGuardian
00811571030842EyeGuardian Sensitive

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