Joinix Cannula System

GUDID 08800039100854

For introduction of instrumentation through a portal for surgical procedure.

AJU PHARM. CO., LTD.

Arthroscopic access cannula, single-use

• Primary Device ID: 08800039100854
• NIH Device Record Key: 3fcdab54-3d55-49bf-9bf7-a8e3bc303ace
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Joinix Cannula System
• Version Model Number: ACT82572b
• Company DUNS: 963422810
• Company Name: AJU PHARM. CO., LTD.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: true
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: false
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	08800039100854 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K162070

FDA Product Code

• HRX: Arthroscope

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: true

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2025-01-14
• Device Publish Date: 2025-01-06

On-Brand Devices [Joinix Cannula System]

• 08800039100854: For introduction of instrumentation through a portal for surgical procedure.
• 08800039100236: For introduction of instrumentation through a portal for surgical procedure.