SANTA BARBARA IMAGING SYSTEMS, INC.

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, Arthroscopic (NBH) (1) Arthroscope (HRX) (1)

Premarket Exempt

No Yes

Clear

ZEOS - 00812231030004 Catalog Number : 84-10-1200

Device Description : ZEOS TABLET

Device Class :

Duns Number: 065016344

Premarket Exempt : No

Product Code : GCJ

Prescription Use : Yes

Device Count : 1

ZEOS - 00812231030011 Catalog Number : 84-10-2210

Device Description : ZEOS HD CAMERA CONTROL UNIT

Device Class :

Duns Number: 065016344

Premarket Exempt : No

Product Code : GCJ

Prescription Use : Yes

Device Count : 1

ZEOS - 00812231030028 Catalog Number : 84-10-2300

Device Description : ZEOS HD CAMERA HEAD, INTEGRATED

Device Class :

Duns Number: 065016344

Premarket Exempt : No

Product Code : GCJ

Prescription Use : Yes

Device Count : 1

ZEOS - 00812231030035 Catalog Number : 84-10-2330

Device Description : ZEOS HD CAMERA HEAD, C-MOUNT

Device Class :

Duns Number: 065016344

Premarket Exempt : No

Product Code : GCJ

Prescription Use : Yes

Device Count : 1

ZEOS - 00812231030042 Catalog Number : 84-10-4210

Device Description : ZEOS 4K UHD CAMERA CONTROL UNIT

Device Class :

Duns Number: 065016344

Premarket Exempt : No

Product Code : GCJ

Prescription Use : Yes

Device Count : 1

ZEOS - 00812231030059 Catalog Number : 84-10-4330

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

Device Class :

Duns Number: 065016344

Premarket Exempt : No

Product Code : GCJ

Prescription Use : Yes

Device Count : 1

ZEOS - 00812231030066 Catalog Number : 84-10-4300

Device Description : ZEOS 4K UHD CAMERA HEAD, INTEGRATED

Device Class :

Duns Number: 065016344

Premarket Exempt : No

Product Code : GCJ

Prescription Use : Yes

Device Count : 1

ZEOS - 00812231030103 Catalog Number : 84-14-5500

Device Description : 4K LAPAROSCOPE, 5.5MM 0DEG

Device Class :

Duns Number: 065016344

Premarket Exempt : No

Product Code : GCJ

Prescription Use : Yes

Device Count : 1

ZEOS - 00812231030110 Catalog Number : 84-24-4032

Device Description : 4.2MM BLUNT OBTURATOR

Device Class :

Duns Number: 065016344

Premarket Exempt : Yes

Product Code : NBH

Prescription Use : Yes

Device Count : 1

ZEOS - 00812231030134 Catalog Number : 84-14-4030

Device Description : 4K ARTHROSCOPE, 4MM 30DEG

Device Class :

Duns Number: 065016344

Premarket Exempt : No

Product Code : HRX

Prescription Use : Yes

Device Count : 1

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