ZEOS

Basic Information

• Brand Name: ZEOS
• Primary DI: 00812231030257
• Version / Model: 84-14-1000
• Catalog Number: 84-14-1000
• 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: 2018-08-24
• Public Version: 1
• Public Version Date: 2018-09-24
• Public Version Status: New
• Public Device Record Key: 65c026c4-46de-401e-9387-38f4d6d63a55

Device Description

4K LAPAROSCOPE, 10MM 0DEG

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: No
• 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: Yes
• Sterilization Methods: Moist Heat or Steam Sterilization

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
12291	Rigid optical laparoscope	An endoscope with a rigid inserted portionangulus iridocornealis for the visual examination and treatment of the abdominal/retroperitoneal cavity and its organs. It is inserted through an incision made in the abdominal wall (routinely just below the umbilicus) during laparoscopy. Anatomical images are transmitted to the user by the device through relayed lens optics or a fibreoptic bundle. The abdominal wall is distended, typically using a gas, providing the space to allow the surgeon to view and/or operate on the exposed organs. This reusable device is commonly used to evaluate/treat abdominal or pelvic pain, ectopic pregnancy, ovarian cysts, appendicitis, and perform female sterilization.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00812231030257	GS1
Package	00812231030721	GS1	Repair-Replace	1	In Commercial Distribution
Package	00812231030622	GS1	Loaner	1	In Commercial Distribution

Customer Contacts

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