Aquas Powerflow

GUDID 00877972007012

GENICON, INC.

Disposable surgical irrigation/aspiration system Disposable surgical irrigation/aspiration system Disposable surgical irrigation/aspiration system Disposable surgical irrigation/aspiration system Disposable surgical irrigation/aspiration system Disposable surgical irrigation/aspiration system Disposable surgical irrigation/aspiration system Disposable surgical irrigation/aspiration system Disposable surgical irrigation/aspiration system Disposable surgical irrigation/aspiration system

• Primary Device ID: 00877972007012
• NIH Device Record Key: 0e575255-93bd-480b-adeb-90193ec74a6d
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Aquas Powerflow
• Version Model Number: 720-005-003
• Company DUNS: 079805400
• Company Name: GENICON, 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: true
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: true
• RX Perscription: false
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	00877972007012 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K041967

FDA Product Code

• GCJ: Laparoscope, General & Plastic Surgery

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 4
• Public Version Date: 2019-02-21
• Device Publish Date: 2017-12-20

On-Brand Devices [Aquas Powerflow]

• 00877972007012: 720-005-003
• 00877972006992: 720-005-002
• 00877972006978: 720-005-000
• 00877972006152: 720-005-001