Opti-Gard D28400

GUDID 00850017419070

LASER OPTI-GARD LARGE NON-STERILE PACK

DUPACO, INC.

Radiation shielding goggles/spectacles Radiation shielding goggles/spectacles Radiation shielding goggles/spectacles Radiation shielding goggles/spectacles Radiation shielding goggles/spectacles Radiation shielding goggles/spectacles Radiation shielding goggles/spectacles Radiation shielding goggles/spectacles
Primary Device ID00850017419070
NIH Device Record Keyd76be215-dc82-4427-ab11-a53567ecaf9e
Commercial Distribution StatusIn Commercial Distribution
Brand NameOpti-Gard
Version Model NumberD28400
Catalog NumberD28400
Company DUNS093616555
Company NameDUPACO, INC.
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-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
GS100850017419070 [Unit of Use]
GS100850017419070 [Unit of Use]
GS100850017419070 [Unit of Use]
GS100850017419070 [Unit of Use]
GS100850017419070 [Unit of Use]
GS100850017419070 [Unit of Use]
GS100850017419070 [Unit of Use]
GS100850017419070 [Unit of Use]
GS110850017419077 [Primary]
GS110850017419077 [Primary]
GS110850017419077 [Primary]
GS110850017419077 [Primary]
GS110850017419077 [Primary]
GS110850017419077 [Primary]
GS110850017419077 [Primary]
GS110850017419077 [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

© 2020 FDA.report
This site is not affiliated with or endorsed by the FDA.