ITOOL 209-01

GUDID 16957277200927

DISPOSABLE PULSE IRRIGATION KIT(APPLY TO EXTREMITY)

Apex (Guangzhou) Tools & Orthopedics Co.

Disposable surgical irrigation/aspiration system

• Primary Device ID: 16957277200927
• NIH Device Record Key: e9137717-b6a8-4f42-80a5-cef3985aa92f
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: ITOOL
• Version Model Number: 209-01
• Catalog Number: 209-01
• Company DUNS: 529936792
• Company Name: Apex (Guangzhou) Tools & Orthopedics Co.
• Device Count: 10
• DM Exempt: false
• Pre-market Exempt: true
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: true
• 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	06957277200944 [Primary]
GS1	16957277200927 [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: 2021-04-08
• Device Publish Date: 2021-03-31

On-Brand Devices [ITOOL]

• 16957277200958: DISPOSABLE PULSE IRRIGATION KIT(APPLY TO TRUNK-M)
• 06957277200968: DISPOSABLE PULSE IRRIGATION KIT(APPLY TO TRUNK-M)
• 16957277200927: DISPOSABLE PULSE IRRIGATION KIT(APPLY TO EXTREMITY)
• 06957277200937: DISPOSABLE PULSE IRRIGATION KIT(APPLY TO EXTREMITY)