Joinix Cannula System

Basic Information

• Brand Name: Joinix Cannula System
• Primary DI: 08800039100854
• Version / Model: ACT82572b
• Company Name: AJU PHARM. CO., LTD.
• Labeler DUNS: 963422810
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2025-01-06
• Public Version: 1
• Public Version Date: 2025-01-14
• Public Version Status: New
• Public Device Record Key: 3fcdab54-3d55-49bf-9bf7-a8e3bc303ace

Device Description

For introduction of instrumentation through a portal for surgical procedure.

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): No
• 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: No
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: No
• Has Expiration Date: Yes
• Has Donation ID: No

Sterilization

• Is Sterile: Yes
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
HRX	Arthroscope	Orthopedic	888.1100	2

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
Primary	08800039100854	GS1

Premarket Submissions

Submission Number	Supplement Number
K162070	000