iTool® APEXPULSE™ 201-02-00

GUDID 06972130470012

Disposable Pulse Lavage Component Kit

Apex (Suzhou) Medical Products Company

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 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 Disposable surgical irrigation/aspiration system

• Primary Device ID: 06972130470012
• NIH Device Record Key: 29023e2c-7a47-4cce-a337-753c6a6945dd
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: iTool® APEXPULSE™
• Version Model Number: 201-02-00
• Catalog Number: 201-02-00
• Company DUNS: 554507451
• Company Name: Apex (Suzhou) Medical Products Company
• Device Count: 6
• DM Exempt: false
• Pre-market Exempt: true
• 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: false
• RX Perscription: false
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	06972130470012 [Primary]
GS1	16972130470019 [Unit of Use]

FDA Product Code

• FQH: Lavage, Jet

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: 2020-02-20
• Device Publish Date: 2020-02-12

On-Brand Devices [iTool® APEXPULSE™]

• 06972130470029: Disposable Pulse Lavage Knee Kit
• 06972130470012: Disposable Pulse Lavage Component Kit
• 16972130470026: Disposable Pulse Lavage Knee Kit