IRRI-FLO I

GUDID 00821925009523

IRRI-FLO I Irrigation Delivery System

Gyrus Acmi, Inc.

Surgical irrigation tubing set, single-use

• Primary Device ID: 00821925009523
• NIH Device Record Key: cc765549-e14b-4f16-b841-652c8fdd6f8b
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: IRRI-FLO I
• Version Model Number: 5920000
• Company DUNS: 007198742
• Company Name: Gyrus Acmi, Inc.
• 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: true
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	00821925009523 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K891339

FDA Product Code

• OCX: Endoscopic Irrigation/Suction System

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: 2024-08-02
• Device Publish Date: 2024-07-25

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