SANTA BARBARA IMAGING SYSTEMS, INC.

Address:340 Storke Rd Ste 101,Goleta,CA,93117,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

Adaptor, Bulbs, Miscellaneous, For Endoscope (FFY) (3) Sterilization Wrap Containers, Trays, Cassettes & Other Accessories (KCT) (3) Arthroscope (HRX) (2) Light, Surgical, Fiberoptic (FST) (2)

Premarket Exempt

No Yes

Clear

ZEOS - 00812231030318 Catalog Number : 84-18-1002

Device Description : LAPAROSCOPE TRAY, LARGE

Device Class :

Duns Number: 065016344

Premarket Exempt : No

Product Code : KCT

Prescription Use : No

Device Count : 1

ZEOS - 00812231030325 Catalog Number : 84-18-1003

Device Description : LAPAROSCOPE TRAY, SMALL

Device Class :

Duns Number: 065016344

Premarket Exempt : No

Product Code : KCT

Prescription Use : No

Device Count : 1

ZEOS - 00812231030332 Catalog Number : 84-18-1004

Device Description : CAMERA HEAD TRAY

Device Class :

Duns Number: 065016344

Premarket Exempt : No

Product Code : KCT

Prescription Use : No

Device Count : 1

ZEOS - 00812231030349 Catalog Number : 84-20-5002

Device Description : 5MM LIGHT GUIDE, GREY

Device Class :

Duns Number: 065016344

Premarket Exempt : No

Product Code : FST

Prescription Use : Yes

Device Count : 1

ZEOS - 00812231030356 Catalog Number : 84-20-5003

Device Description : 5MM LIGHT GUIDE, BLUE

Device Class :

Duns Number: 065016344

Premarket Exempt : No

Product Code : FST

Prescription Use : Yes

Device Count : 1

ZEOS - 00812231030363 Catalog Number : 84-20-50032

Device Description : ACMI LIGHT GUIDE POST ADAPTER

Device Class : 1

Duns Number: 065016344

Premarket Exempt : Yes

Product Code : FFY

Prescription Use : Yes

Device Count : 1

ZEOS - 00812231030370 Catalog Number : 84-20-50031

Device Description : WOLF LIGHT GUIDE POST ADAPTER

Device Class : 1

Duns Number: 065016344

Premarket Exempt : Yes

Product Code : FFY

Prescription Use : Yes

Device Count : 1

ZEOS - 00812231030387 Catalog Number : 84-20-50033

Device Description : STORZ LIGHT GUIDE POST ADAPTER

Device Class : 1

Duns Number: 065016344

Premarket Exempt : Yes

Product Code : FFY

Prescription Use : Yes

Device Count : 1

ZEOS - 00812231030431 Catalog Number : 84-14-4130

Device Description : 4K C-MOUNT ARTHROSCOPE, 4MM 30DEG

Device Class :

Duns Number: 065016344

Premarket Exempt : No

Product Code : HRX

Prescription Use : Yes

Device Count : 1

ZEOS - 00812231030448 Catalog Number : 84-14-4100

Device Description : 4K C-MOUNT ARTHROSCOPE, 4MM 0DEG

Device Class :

Duns Number: 065016344

Premarket Exempt : No

Product Code : HRX

Prescription Use : Yes

Device Count : 1

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