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

Laparoscope, General & Plastic Surgery (GCJ) (4) Adaptor, Bulbs, Miscellaneous, For Endoscope (FFY) (3) Light, Surgical, Fiberoptic (FST) (2) Sterilization Wrap Containers, Trays, Cassettes & Other Accessories (KCT) (1)

Premarket Exempt

No Yes

Clear

OMNI - 00812231032886 Catalog Number : 83-20-5002

Device Description : 5MM LIGHT GUIDE, GREY

Device Class : 2

Duns Number: 065016344

Premarket Exempt : No

Product Code : FST

Prescription Use : Yes

Device Count : 1

OMNI - 00812231032893 Catalog Number : 83-20-5003

Device Description : 5MM LIGHT GUIDE, BLUE

Device Class : 2

Duns Number: 065016344

Premarket Exempt : No

Product Code : FST

Prescription Use : Yes

Device Count : 1

OMNI - 00812231032909 Catalog Number : 83-20-50031

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

OMNI - 00812231032916 Catalog Number : 83-20-50033

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

OMNI - 00812231032923 Catalog Number : 83-20-50032

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

OMNI - 00812231032947 Catalog Number : 83-18-1004

Device Description : CAMERA HEAD TRAY, HOLOGIC

Device Class : 2

Duns Number: 065016344

Premarket Exempt : No

Product Code : KCT

Prescription Use : No

Device Count : 1

Pixa - 00853460007009 Catalog Number : 85-10-2010

Device Description : Camera Control Unit, Pixa Console with Image Capture & Light Engine

Device Class : 2

Duns Number: 065016344

Premarket Exempt : No

Product Code : GCJ

Prescription Use : Yes

Device Count : 1

Pixa - 00853460007016 Catalog Number : 85-10-2100

Device Description : Camera Head, Pixa Integrated

Device Class : 2

Duns Number: 065016344

Premarket Exempt : No

Product Code : GCJ

Prescription Use : Yes

Device Count : 1

Pixa - 00853460007023 Catalog Number : 85-10-2130

Device Description : CAMERA HEAD HD C-MOUNT 3CMOS

Device Class : 2

Duns Number: 065016344

Premarket Exempt : No

Product Code : GCJ

Prescription Use : Yes

Device Count : 1

Pixa - 00853460007030 Catalog Number : 85-10-1000

Device Description : Tablet, Pixa

Device Class :

Duns Number: 065016344

Premarket Exempt : No

Product Code : GCJ

Prescription Use : Yes

Device Count : 1

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