OptiBond Universal 360

GUDID 00195062064524

OptiBond Universal 360 Unidose Kit

Kerr Corporation

Dentine bonding agent/set

• Primary Device ID: 00195062064524
• NIH Device Record Key: 30beefb2-397e-4e6a-8f57-af6a85c66081
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: OptiBond Universal 360
• Version Model Number: 36886
• 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: 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: true
• OTC Over-The-Counter: false

Operating and Storage Conditions

• Special Storage Condition, Specify: Between 0 and 0 *Storage Environment Temperature
• Special Storage Condition, Specify: Between 0 and 0 *Storage Environment Temperature
• Special Storage Condition, Specify: Between 0 and 0 *Storage Environment Temperature
• Special Storage Condition, Specify: Between 0 and 0 *Storage Environment Temperature
• Special Storage Condition, Specify: Between 0 and 0 *Storage Environment Temperature
• Special Storage Condition, Specify: Between 0 and 0 *Storage Environment Temperature
• Special Storage Condition, Specify: Between 0 and 0 *Storage Environment Temperature
• Special Storage Condition, Specify: Between 0 and 0 *Storage Environment Temperature
• Special Storage Condition, Specify: Between 0 and 0 *Storage Environment Temperature
• Special Storage Condition, Specify: Between 0 and 0 *Storage Environment Temperature
• Special Storage Condition, Specify: Between 0 and 0 *Storage Environment Temperature
• Special Storage Condition, Specify: Between 0 and 0 *Storage Environment Temperature
• Special Storage Condition, Specify: Between 0 and 0 *Storage Environment Temperature
• Special Storage Condition, Specify: Between 0 and 0 *Storage Environment Temperature
• Special Storage Condition, Specify: Between 0 and 0 *Storage Environment Temperature
• Special Storage Condition, Specify: Between 0 and 0 *Storage Environment Temperature
• Special Storage Condition, Specify: Between 0 and 0 *Storage Environment Temperature

Device Identifiers

Device Issuing Agency	Device ID
GS1	00195062064524 [Package]; Contains: 00195062068508; Package: Case [100 Units]; In Commercial Distribution
GS1	00195062068508 [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