i-Smile 01600

GUDID H668016001

i-Smile General Purpose Ultrasonic Liquid

Keystone Industries

Medical device cleaning agent

• Primary Device ID: H668016001
• NIH Device Record Key: 641b8273-4a93-455f-ad34-6afb4dfe19c0
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: i-Smile
• Version Model Number: 01600
• Catalog Number: 01600
• Company DUNS: 073503117
• Company Name: Keystone Industries
• Device Count: 1
• 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: false
• 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

Customer Support Contacts

• Phone: +1(800)333-3131
• Email: tschwear@keystoneind.com
• Phone: +1(800)333-3131
• Email: tschwear@keystoneind.com
• Phone: +1(800)333-3131
• Email: tschwear@keystoneind.com
• Phone: +1(800)333-3131
• Email: tschwear@keystoneind.com
• Phone: +1(800)333-3131
• Email: tschwear@keystoneind.com
• Phone: +1(800)333-3131
• Email: tschwear@keystoneind.com
• Phone: +1(800)333-3131
• Email: tschwear@keystoneind.com
• Phone: +1(800)333-3131
• Email: tschwear@keystoneind.com

Device Dimensions

• Total Volume: 1 Gallon
• Total Volume: 1 Gallon
• Total Volume: 1 Gallon
• Total Volume: 1 Gallon
• Total Volume: 1 Gallon
• Total Volume: 1 Gallon
• Total Volume: 1 Gallon
• Total Volume: 1 Gallon

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	H668016001 [Primary]

FDA Product Code

• FLG: Cleaner, ultrasonic, medical instrument

Sterilization

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

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2022-12-08
• Device Publish Date: 2022-11-30

On-Brand Devices [i-Smile]

• H668016011: i-Smile Tartar & Stain Remover Liquid
• H668016001: i-Smile General Purpose Ultrasonic Liquid