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

Premarket Exempt

No Yes

Clear

ZEOS - 00812231031605 Catalog Number : 84-10-2220

Device Description : ZEOS ZOOM COUPLER, F=16-34MM

Device Class : 1

Duns Number: 065016344

Premarket Exempt : Yes

Product Code : FEM

Prescription Use : Yes

Device Count : 1

ZEOS - 00812231031865 Catalog Number : 84-10-4310

Device Description : ZEOS 4K UHD CAMERA HEAD, C-MOUNT, 1CMOS

Device Class :

Duns Number: 065016344

Premarket Exempt : No

Product Code : GCJ

Prescription Use : Yes

Device Count : 1

ZEOS - 00812231031872 Catalog Number : 84-10-4320

Device Description : ZEOS 4K UHD CAMERA HEAD, INTEGRATED, 1CMOS

Device Class :

Duns Number: 065016344

Premarket Exempt : No

Product Code : GCJ

Prescription Use : Yes

Device Count : 1

ZEOS - 00812231031889 Catalog Number : 84-10-1400

Device Description : ZEOS TABLET, JPN

Device Class : 2

Duns Number: 065016344

Premarket Exempt : No

Product Code : GCJ

Prescription Use : Yes

Device Count : 1

ZEOS - 00812231031896 Catalog Number : 84-10-2410

Device Description : ZEOS HD CAMERA CONTROL UNIT, JPN

Device Class : 2

Duns Number: 065016344

Premarket Exempt : No

Product Code : GCJ

Prescription Use : Yes

Device Count : 1

ZEOS - 00812231031902 Catalog Number : 84-10-4410

Device Description : ZEOS 4K UHD CAMERA CONTROL UNIT, JPN

Device Class : 2

Duns Number: 065016344

Premarket Exempt : No

Product Code : GCJ

Prescription Use : Yes

Device Count : 1

ZEOS - 00812231031957 Catalog Number : 84-10-2020

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

OMNI - 00812231032824 Catalog Number : 83-10-4010

Device Description : 4K UHD CAMERA CONTROL UNIT

Device Class : 2

Duns Number: 065016344

Premarket Exempt : No

Product Code : GCJ

Prescription Use : Yes

Device Count : 1

OMNI - 00812231032831 Catalog Number : 83-10-1000

Device Description : TABLET, HOLOGIC

Device Class :

Duns Number: 065016344

Premarket Exempt : No

Product Code : GCJ

Prescription Use : Yes

Device Count : 1

OMNI - 00812231032862 Catalog Number : 83-10-4120

Device Description : 4K UHD CAMERA HEAD, INTEGRATED, 1CMOS, HOLOGIC

Device Class : 2

Duns Number: 065016344

Premarket Exempt : No

Product Code : GCJ

Prescription Use : Yes

Device Count : 1

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