ZEOS

Basic Information

• Brand Name: ZEOS
• Primary DI: 00812231031094
• Version / Model: 84-24-2720
• Catalog Number: 84-24-2720
• 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: 2018-12-03
• Public Version: 2
• Public Version Date: 2019-01-23
• Public Version Status: Update
• Public Device Record Key: da861b56-ea03-4489-9e63-555f5b4bc8f6

Device Description

3.8MM SHEATH, DOUBLE STOPCOCK

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: Yes
• Has Serial Number: No
• Has Lot/Batch Number: Yes
• 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
NBH	Accessories, Arthroscopic	Orthopedic	888.1100	1

GMDN Terms

Code	Name	Definition	Implantable	Status
58752	Arthroscopic access cannula, single-use	A single-lumen surgical device intended to be percutaneously inserted into a joint to create an access port for an arthroscope/arthroscopic instrument during arthroscopy. The cannula is designed to facilitate the passage of surgical instruments while preventing the escape of irrigation fluid and typically includes an internal watertight seal, and a port for drainage of fluid. It is available in a variety of dimensions and/or designs and may include one or more obturator(s) to facilitate insertion. This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Package	00812231031803	GS1	LOANER	1	In Commercial Distribution
Primary	00812231031094	GS1

Customer Contacts

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