ZEOS

Basic Information

• Brand Name: ZEOS
• Primary DI: 00812231030042
• Version / Model: 84-10-4210
• Catalog Number: 84-10-4210
• Company Name: SANTA BARBARA IMAGING SYSTEMS, INC.
• Labeler DUNS: 065016344
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2018-06-29
• Public Version: 5
• Public Version Date: 2021-02-24
• Public Version Status: Update
• Public Device Record Key: 494a9767-42cf-43ef-a49c-d3f1413e8a5b

Device Description

ZEOS 4K UHD CAMERA CONTROL UNIT

Device Characteristics

• Single Use: No
• Prescription Use (Rx): Yes
• Over the Counter (OTC): No
• Kit: No
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: No
• MRI Safety: Labeling does not contain MRI Safety Information
• Direct Marking Exempt: Yes
• PM Exempt: No
• Has Serial Number: Yes
• Has Lot/Batch Number: No
• Has Manufacturing Date: Yes
• Has Expiration Date: No
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
GCJ	Laparoscope, General & Plastic Surgery	Gastroenterology, Urology	876.1500	2

GMDN Terms

Code	Name	Definition	Implantable	Status
18034	Endoscopic video image processing unit	An electrically-powered device designed to receive and process the electronic signals sent from a video endoscope or endoscopic video camera; it does not include the endoscope nor light source and is not designed to control the endoscope. It may have additional features which compensate for/enhance the colour and light qualities provided. The resulting picture images are sent to and shown on a visual display unit (VDU), typically to assist the endoscope operator with an ongoing intervention and often to allow the patient visualization of the process; the images can be recorded on a video recorder or stored on computerized media.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00812231030042	GS1
Package	00812231030479	GS1	Loaner	1	In Commercial Distribution
Package	00812231033104	GS1	Repair-Replace	1	In Commercial Distribution

Customer Contacts

• Phone: [phone]
• Email: [email protected]