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) (2) Accessories, Photographic, For Endoscope (Exclude Light Sources) (FEM) (1)

Premarket Exempt

No Yes

Clear

Trinty - 00853460007450 Catalog Number : 81-10-4210

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

Pixa - 00853460007504 Catalog Number : 85-10-4120

Device Description : Camera Head, Pixa, Integrated, 4K, 1CMOS

Device Class :

Duns Number: 065016344

Premarket Exempt : No

Product Code : GCJ

Prescription Use : Yes

Device Count : 1

Imaging - 00853460007559 Catalog Number : 87-10-2020

Device Description : ZOOM Coupler, F=16-34MM

Device Class : 1

Duns Number: 065016344

Premarket Exempt : Yes

Product Code : FEM

Prescription Use : Yes

Device Count : 1

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