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

Arthroscope (HRX) (5) Laparoscope, General & Plastic Surgery (GCJ) (2) Accessories, Arthroscopic (NBH) (1) Accessory Equipment, Cardiopulmonary Bypass (KRI) (1) Sterilization Wrap Containers, Trays, Cassettes & Other Accessories (KCT) (1)

Premarket Exempt

No Yes

Clear

ZEOS - 00812231031117 Catalog Number : 84-24-2722

Device Description : 2.9MM BLUNT OBTURATOR

Device Class : 1

Duns Number: 065016344

Premarket Exempt : Yes

Product Code : NBH

Prescription Use : Yes

Device Count : 1

ZEOS - 00812231031223 Catalog Number : 84-14-1900

Device Description : ARTHROSCOPE, 1.9MM 0DEG

Device Class :

Duns Number: 065016344

Premarket Exempt : No

Product Code : HRX

Prescription Use : Yes

Device Count : 1

ZEOS - 00812231031230 Catalog Number : 84-14-1930

Device Description : ARTHROSCOPE, 1.9MM 30DEG

Device Class :

Duns Number: 065016344

Premarket Exempt : No

Product Code : HRX

Prescription Use : Yes

Device Count : 1

ZEOS - 00812231031247 Catalog Number : 84-14-2700

Device Description : ARTHROSCOPE, 2.7MM 0DEG

Device Class :

Duns Number: 065016344

Premarket Exempt : No

Product Code : HRX

Prescription Use : Yes

Device Count : 1

ZEOS - 00812231031254 Catalog Number : 84-14-2730

Device Description : ARTHROSCOPE, 2.7MM 30DEG

Device Class :

Duns Number: 065016344

Premarket Exempt : No

Product Code : HRX

Prescription Use : Yes

Device Count : 1

ZEOS - 00812231031261 Catalog Number : 84-14-2770

Device Description : ARTHROSCOPE, 2.7MM 70DEG

Device Class :

Duns Number: 065016344

Premarket Exempt : No

Product Code : HRX

Prescription Use : Yes

Device Count : 1

ZEOS - 00812231031384 Catalog Number : 84-14-1045

Device Description : 4K LAPAROSCOPE, 10MM 45DEG

Device Class :

Duns Number: 065016344

Premarket Exempt : No

Product Code : GCJ

Prescription Use : Yes

Device Count : 1

ZEOS - 00812231031421 Catalog Number : 84-14-5547

Device Description : 4K LAPAROSCOPE, 5.5MM 45DEG

Device Class :

Duns Number: 065016344

Premarket Exempt : No

Product Code : GCJ

Prescription Use : Yes

Device Count : 1

ZEOS - 00812231031582 Catalog Number : 84-28-0522

Device Description : ZEOS CART CO2 BOTTLE HOLDER

Device Class : 1

Duns Number: 065016344

Premarket Exempt : Yes

Product Code : KRI

Prescription Use : Yes

Device Count : 1

ZEOS - 00812231031599 Catalog Number : 84-18-1010

Device Description : MASTER TRAY

Device Class : 2

Duns Number: 065016344

Premarket Exempt : No

Product Code : KCT

Prescription Use : No

Device Count : 1

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