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) (6) Adaptor, Bulbs, Miscellaneous, For Endoscope (FFY) (3) Light, Surgical, Fiberoptic (FST) (1)

Premarket Exempt

No Yes

Clear

Imaging (ZEOS) - 00853460007160 Catalog Number : 84-20-5005

Device Description : LIGHTCABLE 3M BLUE W/ STORZ ADAPTER

Device Class : 2

Duns Number: 065016344

Premarket Exempt : No

Product Code : FST

Prescription Use : Yes

Device Count : 1

Imaging (ZEOS) - 00853460007177 Catalog Number : 84-20-50035

Device Description : WOLF ADAPTER

Device Class : 1

Duns Number: 065016344

Premarket Exempt : Yes

Product Code : FFY

Prescription Use : Yes

Device Count : 1

Imaging (ZEOS) - 00853460007184 Catalog Number : 84-20-50036

Device Description : ACMI ADAPTER

Device Class : 1

Duns Number: 065016344

Premarket Exempt : Yes

Product Code : FFY

Prescription Use : Yes

Device Count : 1

Imaging (ZEOS) - 00853460007191 Catalog Number : 84-20-50037

Device Description : STORZ ADAPTER

Device Class : 1

Duns Number: 065016344

Premarket Exempt : Yes

Product Code : FFY

Prescription Use : Yes

Device Count : 1

Imaging (ZEOS) - 00853460007221 Catalog Number : 84-10-2120

Device Description : CAMERA HEAD HD 1CMOS

Device Class : 2

Duns Number: 065016344

Premarket Exempt : No

Product Code : GCJ

Prescription Use : Yes

Device Count : 1

Pixa - 00853460007245 Catalog Number : 85-10-4100

Device Description : Camera Head, Pixa Integrated 4K

Device Class :

Duns Number: 065016344

Premarket Exempt : No

Product Code : GCJ

Prescription Use : Yes

Device Count : 1

Pixa - 00853460007252 Catalog Number : 85-10-4110

Device Description : Camera Head, Pixa, C-Mount, 4K, 1CMOS

Device Class :

Duns Number: 065016344

Premarket Exempt : No

Product Code : GCJ

Prescription Use : Yes

Device Count : 1

Pixa - 00853460007269 Catalog Number :

Device Description : Camera Head, Pixa C-Mount, 4K, 3CMOS

Device Class :

Duns Number: 065016344

Premarket Exempt : No

Product Code : GCJ

Prescription Use : Yes

Device Count : 1

Pixa - 00853460007283 Catalog Number : 85-10-4000

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

Device Class : 2

Duns Number: 065016344

Premarket Exempt : No

Product Code : GCJ

Prescription Use : Yes

Device Count : 1

Imaging (ZEOS) - 00853460007290 Catalog Number : 84-10-4010

Device Description : ZEOS 4K UHD CAMERA CONTROL UNIT

Device Class : 2

Duns Number: 065016344

Premarket Exempt : No

Product Code : GCJ

Prescription Use : Yes

Device Count : 1

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