i-Smile 01601

GUDID H668016011

i-Smile Tartar & Stain Remover Liquid

Keystone Industries

Medical device cleaning agent Medical device cleaning agent Medical device cleaning agent Medical device cleaning agent Medical device cleaning agent Medical device cleaning agent Medical device cleaning agent Medical device cleaning agent

• Primary Device ID: H668016011
• NIH Device Record Key: 76c98746-689d-4258-8d73-c52cc1269e74
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: i-Smile
• Version Model Number: 01601
• Catalog Number: 01601
• 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	H668016011 [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