DUPACO, INC.

Address:4144 AVENIDA DE LA PLATA,OCEANSIDE,CA,92056,US

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Filters

Device Class

Class-1 (A medical device with low to moderate risk that requires general controls) Class-2 (A medical device with a moderate to high risk that requires special controls) Class-3 (A medical device with high risk that requires premarket approval) Class-U (Unclassified)

Product Code

Shield, eye, ophthalmic (including sunlamp protective eyewear and post-mydriatic eyewear) (HOY) (7) Shield, eye, radiological (IWS) (7) SUPPORT, PATIENT POSITION (CCX) (3)

Premarket Exempt

Yes

Clear

ProneView - 00850017419346 Catalog Number : D28705CE

Device Description : PRONEVIEW TABLE PLATFORMWITH PROTECTIVE HELMET Kit

Device Class : 1

Duns Number: 093616555

Premarket Exempt : Yes

Product Code : CCX

Prescription Use : Yes

Device Count : 1

ProneView - 00850017419353 Catalog Number : D28510CE

Device Description : PRONEVIEW ADJUSTABLE PROTECTIVE HELMET AND MIRROR SYS Kit

Device Class : 1

Duns Number: 093616555

Premarket Exempt : Yes

Product Code : CCX

Prescription Use : Yes

Device Count : 1

Opti-Gard - 10850017419039 Catalog Number : D28200CE

Device Description : Opti-Gard SMALL CE NON-STERILE PACK

Device Class : 1

Duns Number: 093616555

Premarket Exempt : Yes

Product Code : HOY, IWS

Prescription Use : Yes

Device Count : 25

Opti-Gard - 10850017419046 Catalog Number : D28300CE

Device Description : Opti-Gard LARGE CE NON-STERILE PACK

Device Class : 1

Duns Number: 093616555

Premarket Exempt : Yes

Product Code : HOY, IWS

Prescription Use : Yes

Device Count : 25

Opti-Gard - 10850017419053 Catalog Number : D28300F

Device Description : Opti-Gard DOUBLE FOAM NON-STERILE PACK

Device Class : 1

Duns Number: 093616555

Premarket Exempt : Yes

Product Code : HOY, IWS

Prescription Use : Yes

Device Count : 25

Opti-Gard - 10850017419060 Catalog Number : D28310

Device Description : Opti-Gard LARGE STERILE PACK

Device Class : 1

Duns Number: 093616555

Premarket Exempt : Yes

Product Code : IWS, HOY

Prescription Use : Yes

Device Count : 25

Opti-Gard - 10850017419077 Catalog Number : D28400

Device Description : LASER OPTI-GARD LARGE NON-STERILE PACK

Device Class : 1

Duns Number: 093616555

Premarket Exempt : Yes

Product Code : HOY, IWS

Prescription Use : Yes

Device Count : 10

Opti-Gard - 10850017419084 Catalog Number : D29400

Device Description : CHIN UP FOAM END PACK

Device Class : 1

Duns Number: 093616555

Premarket Exempt : Yes

Product Code : HOY, IWS

Prescription Use : Yes

Device Count : 20

Opti-Gard - 10850017419091 Catalog Number : D29401

Device Description : CHIN UP FLEXIBLE ARM

Device Class : 1

Duns Number: 093616555

Premarket Exempt : Yes

Product Code : IWS, HOY

Prescription Use : Yes

Device Count : 1

ProneView - 10850017419107 Catalog Number : D28507CE

Device Description : SMALL CUSHION 10 PACK

Device Class : 1

Duns Number: 093616555

Premarket Exempt : Yes

Product Code : CCX

Prescription Use : Yes

Device Count : 10

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