OPERATING ROOM INNOVATIONS, INC.

Address:5694 Mission Center Rd STE 602,San Diego,CA,92108,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

Gown, Surgical (FYA) (9) Drape, Surgical (KKX) (1)

Premarket Exempt

No Yes

Clear

ORI - 00850003355016 Catalog Number : SF-4XL-EL

Device Description : Solofit AAMI IV SMS Gown L4, XL, Extra Long

Device Class : 2

Duns Number: 080246656

Premarket Exempt : No

Product Code : FYA

Prescription Use : Yes

Device Count : 1

ORI - 00850003355030 Catalog Number : SF-4XXL-EL

Device Description : Solofit AAMI IV SMS Gown L4, XXL, Extra Long

Device Class : 2

Duns Number: 080246656

Premarket Exempt : No

Product Code : FYA

Prescription Use : Yes

Device Count : 1

SF-3PL Solofit AAMI III SMS Gown Poly Reinforced Large - 00854150007002 Catalog Number : SF-3PL

Device Class : 2

Duns Number: 080246656

Premarket Exempt : No

Product Code : FYA

Prescription Use : Yes

Device Count : 1

SF-3L Solofit AAMI III SMS Gown Large - 00854150007026 Catalog Number : SF-3L

Device Class : 2

Duns Number: 080246656

Premarket Exempt : No

Product Code : FYA

Prescription Use : Yes

Device Count : 1

SF-3XL Solofit AAMI III SMS Gown X-Large - 00854150007040 Catalog Number : SF-3XL

Device Class : 2

Duns Number: 080246656

Premarket Exempt : No

Product Code : FYA

Prescription Use : Yes

Device Count : 1

SF-3PXL Solofit AAMI III SMS Gown Poly Reinforced X-Large - 00854150007064 Catalog Number : SF-3PXL

Device Class : 2

Duns Number: 080246656

Premarket Exempt : No

Product Code : FYA

Prescription Use : Yes

Device Count : 1

SF-3XXL Solofit AAMI III SMS Gown XX-Large - 00854150007071 Catalog Number : SF-3XXL

Device Class : 2

Duns Number: 080246656

Premarket Exempt : No

Product Code : FYA

Prescription Use : No

Device Count : 1

SF-3PXXL Solofit AAMI III SMS Gown Poly Reinforced XX-Large - 00854150007095 Catalog Number : SF-3PXXL

Device Class : 2

Duns Number: 080246656

Premarket Exempt : No

Product Code : FYA

Prescription Use : Yes

Device Count : 1

DS-100 ORI Drop Stop Kit - 00854150007118 Catalog Number : DS-100

Device Class : 2

Duns Number: 080246656

Premarket Exempt : Yes

Product Code : KKX

Prescription Use : Yes

Device Count : 1

ORI Self Donning Tabs Kit - 00854150007132 Catalog Number : SF-SDT-1

Device Description : Surgical Gown ORI Self Donning Tabs Kit

Device Class : 2

Duns Number: 080246656

Premarket Exempt : No

Product Code : FYA

Prescription Use : Yes

Device Count : 1

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