OptiBond Universal 360

GUDID 00195062064500

OptiBond Universal 360 Bottle Kit

Kerr Corporation

Dentine bonding agent/set

• Primary Device ID: 00195062064500
• NIH Device Record Key: e7812e4b-33aa-419e-8b3f-0566c2bdfe23
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: OptiBond Universal 360
• Version Model Number: 36885
• Company DUNS: 199354556
• Company Name: Kerr Corporation
• 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: false
• 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: true
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: 800-537-7123
• Email: KerrCustCare@kerrDental.com
• Phone: 800-537-7123
• Email: KerrCustCare@kerrDental.com
• Phone: 800-537-7123
• Email: KerrCustCare@kerrDental.com
• Phone: 800-537-7123
• Email: KerrCustCare@kerrDental.com
• Phone: 800-537-7123
• Email: KerrCustCare@kerrDental.com
• Phone: 800-537-7123
• Email: KerrCustCare@kerrDental.com
• Phone: 800-537-7123
• Email: KerrCustCare@kerrDental.com
• Phone: 800-537-7123
• Email: KerrCustCare@kerrDental.com
• Phone: 800-537-7123
• Email: KerrCustCare@kerrDental.com
• Phone: 800-537-7123
• Email: KerrCustCare@kerrDental.com
• Phone: 800-537-7123
• Email: KerrCustCare@kerrDental.com
• Phone: 800-537-7123
• Email: KerrCustCare@kerrDental.com
• Phone: 800-537-7123
• Email: KerrCustCare@kerrDental.com
• Phone: 800-537-7123
• Email: KerrCustCare@kerrDental.com
• Phone: 800-537-7123
• Email: KerrCustCare@kerrDental.com
• Phone: 800-537-7123
• Email: KerrCustCare@kerrDental.com
• Phone: 800-537-7123
• Email: KerrCustCare@kerrDental.com

Operating and Storage Conditions

• Special Storage Condition, Specify: Between 0 and 0 *Labeling does not contain MRI Safety information
• Special Storage Condition, Specify: Between 0 and 0 *Labeling does not contain MRI Safety information
• Special Storage Condition, Specify: Between 0 and 0 *Labeling does not contain MRI Safety information
• Special Storage Condition, Specify: Between 0 and 0 *Labeling does not contain MRI Safety information
• Special Storage Condition, Specify: Between 0 and 0 *Labeling does not contain MRI Safety information
• Special Storage Condition, Specify: Between 0 and 0 *Labeling does not contain MRI Safety information
• Special Storage Condition, Specify: Between 0 and 0 *Labeling does not contain MRI Safety information
• Special Storage Condition, Specify: Between 0 and 0 *Labeling does not contain MRI Safety information
• Special Storage Condition, Specify: Between 0 and 0 *Labeling does not contain MRI Safety information
• Special Storage Condition, Specify: Between 0 and 0 *Labeling does not contain MRI Safety information
• Special Storage Condition, Specify: Between 0 and 0 *Labeling does not contain MRI Safety information
• Special Storage Condition, Specify: Between 0 and 0 *Labeling does not contain MRI Safety information
• Special Storage Condition, Specify: Between 0 and 0 *Labeling does not contain MRI Safety information
• Special Storage Condition, Specify: Between 0 and 0 *Labeling does not contain MRI Safety information
• Special Storage Condition, Specify: Between 0 and 0 *Labeling does not contain MRI Safety information
• Special Storage Condition, Specify: Between 0 and 0 *Labeling does not contain MRI Safety information
• Special Storage Condition, Specify: Between 0 and 0 *Labeling does not contain MRI Safety information

Device Identifiers

Device Issuing Agency	Device ID
GS1	00195062064500 [Primary]

FDA Product Code

• KLE: Agent, Tooth Bonding, Resin

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: 2024-07-03
• Device Publish Date: 2024-06-25

On-Brand Devices [OptiBond Universal 360]

• 00195062064524: OptiBond Universal 360 Unidose Kit
• 00195062064531: OptiBond Universal 360 Bottle Refill
• 00195062064500: OptiBond Universal 360 Bottle Kit