Opti-Gard D28200CE

GUDID 00850017419032

Opti-Gard SMALL CE NON-STERILE PACK

DUPACO, INC.

Eye splash shield, single-use Eye splash shield, single-use Eye splash shield, single-use Eye splash shield, single-use Eye splash shield, single-use Eye splash shield, single-use Eye splash shield, single-use Eye splash shield, single-use
Primary Device ID00850017419032
NIH Device Record Keyde39d1a0-d1c9-475e-9f1c-d32915a7c66a
Commercial Distribution StatusIn Commercial Distribution
Brand NameOpti-Gard
Version Model NumberD28200CE
Catalog NumberD28200CE
Company DUNS093616555
Company NameDUPACO, INC.
Device Count25
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-Counterfalse

Customer Support Contacts

Phone+1(760)758-4550
Emaildly@dupacoinc.com
Phone+1(760)758-4550
Emaildly@dupacoinc.com
Phone+1(760)758-4550
Emaildly@dupacoinc.com
Phone+1(760)758-4550
Emaildly@dupacoinc.com
Phone+1(760)758-4550
Emaildly@dupacoinc.com
Phone+1(760)758-4550
Emaildly@dupacoinc.com
Phone+1(760)758-4550
Emaildly@dupacoinc.com
Phone+1(760)758-4550
Emaildly@dupacoinc.com

Operating and Storage Conditions

Storage Environment TemperatureBetween 40 Degrees Fahrenheit and 80 Degrees Fahrenheit
Storage Environment TemperatureBetween 40 Degrees Fahrenheit and 80 Degrees Fahrenheit
Storage Environment TemperatureBetween 40 Degrees Fahrenheit and 80 Degrees Fahrenheit
Storage Environment TemperatureBetween 40 Degrees Fahrenheit and 80 Degrees Fahrenheit
Storage Environment TemperatureBetween 40 Degrees Fahrenheit and 80 Degrees Fahrenheit
Storage Environment TemperatureBetween 40 Degrees Fahrenheit and 80 Degrees Fahrenheit
Storage Environment TemperatureBetween 40 Degrees Fahrenheit and 80 Degrees Fahrenheit
Storage Environment TemperatureBetween 40 Degrees Fahrenheit and 80 Degrees Fahrenheit

Device Identifiers

Device Issuing AgencyDevice ID
GS100850017419032 [Unit of Use]
GS100850017419032 [Unit of Use]
GS100850017419032 [Unit of Use]
GS100850017419032 [Unit of Use]
GS100850017419032 [Unit of Use]
GS100850017419032 [Unit of Use]
GS100850017419032 [Unit of Use]
GS100850017419032 [Unit of Use]
GS110850017419039 [Primary]
GS110850017419039 [Primary]
GS110850017419039 [Primary]
GS110850017419039 [Primary]
GS110850017419039 [Primary]
GS110850017419039 [Primary]
GS110850017419039 [Primary]
GS110850017419039 [Primary]

FDA Product Code

HOYShield, eye, ophthalmic (including sunlamp protective eyewear and post-mydriatic eyewear)
HOYShield, eye, ophthalmic (including sunlamp protective eyewear and post-mydriatic eyewear)
HOYShield, eye, ophthalmic (including sunlamp protective eyewear and post-mydriatic eyewear)
HOYShield, eye, ophthalmic (including sunlamp protective eyewear and post-mydriatic eyewear)
HOYShield, eye, ophthalmic (including sunlamp protective eyewear and post-mydriatic eyewear)
HOYShield, eye, ophthalmic (including sunlamp protective eyewear and post-mydriatic eyewear)
HOYShield, eye, ophthalmic (including sunlamp protective eyewear and post-mydriatic eyewear)
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 Date2020-11-09
Device Publish Date2020-10-30

On-Brand Devices [Opti-Gard]

00850017419339Opti-Gard LARGE CE NON-STERILE PACK, BRAZIL
00850017419322Opti-Gard SMALL CE NON-STERILE PACK, BRAZIL
10850017419091CHIN UP FLEXIBLE ARM
00850017419087CHIN UP FOAM END PACK
00850017419070LASER OPTI-GARD LARGE NON-STERILE PACK
00850017419063Opti-Gard LARGE STERILE PACK
00850017419056Opti-Gard DOUBLE FOAM NON-STERILE PACK
00850017419049Opti-Gard LARGE CE NON-STERILE PACK
00850017419032Opti-Gard SMALL CE NON-STERILE PACK

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