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) (9) Light, Surgical, Fiberoptic (FST) (1)

Premarket Exempt

No Yes

Clear

Pixa - 00853460007047 Catalog Number : 85-10-4010

Device Description : Camera Control Unit, Pixa Console 4K with Image Capture & Light Engine

Device Class :

Duns Number: 065016344

Premarket Exempt : No

Product Code : GCJ

Prescription Use : Yes

Device Count : 1

Trinity - 00853460007054 Catalog Number : 81-10-2010

Device Description : TRINITY HD Camera Control Unit

Device Class : 2

Duns Number: 065016344

Premarket Exempt : No

Product Code : GCJ

Prescription Use : Yes

Device Count : 1

Trinity - 00853460007061 Catalog Number : 81-10-2100

Device Description : TRINITY HD Camera Head 3 CMOS - Eyecup

Device Class : 2

Duns Number: 065016344

Premarket Exempt : No

Product Code : GCJ

Prescription Use : Yes

Device Count : 1

Trinity - 00853460007078 Catalog Number : 81-10-1000

Device Description : Tablet User Interface

Device Class : 2

Duns Number: 065016344

Premarket Exempt : No

Product Code : GCJ

Prescription Use : Yes

Device Count : 1

Imaging (ZEOS) - 00853460007085 Catalog Number : 84-10-2010

Device Description : CAMERA CONTROL UNIT HD 3-IN-1 PLUS

Device Class : 2

Duns Number: 065016344

Premarket Exempt : No

Product Code : GCJ

Prescription Use : Yes

Device Count : 1

Imaging (ZEOS) - 00853460007092 Catalog Number : 84-10-2100

Device Description : CAMERA HEAD HD 3CMOS

Device Class : 2

Duns Number: 065016344

Premarket Exempt : No

Product Code : GCJ

Prescription Use : Yes

Device Count : 1

Imaging (ZEOS) - 00853460007108 Catalog Number : 84-10-1000

Device Description : TABLET USER INTERFACE

Device Class : 2

Duns Number: 065016344

Premarket Exempt : No

Product Code : GCJ

Prescription Use : Yes

Device Count : 1

Trinity - 00853460007139 Catalog Number : 81-10-4010

Device Description : TRINITY 4K Camera Control Unit

Device Class : 2

Duns Number: 065016344

Premarket Exempt : No

Product Code : GCJ

Prescription Use : Yes

Device Count : 1

Trinity - 00853460007146 Catalog Number : 81-10-4100

Device Description : TRINITY 4K Camera Head 3 CMOS - Eyecup

Device Class : 2

Duns Number: 065016344

Premarket Exempt : No

Product Code : GCJ

Prescription Use : Yes

Device Count : 1

Imaging (ZEOS) - 00853460007153 Catalog Number : 84-20-5004

Device Description : LIGHTCABLE 3M GREY W/ STORZ ADAPTER

Device Class : 2

Duns Number: 065016344

Premarket Exempt : No

Product Code : FST

Prescription Use : Yes

Device Count : 1

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