ZenSeal

GUDID 00195062076329

Bio Ceramic Root Canal Sealer Syringe and (2x10Pk) Disposable Tips

Kerr Corporation

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• Primary Device ID: 00195062076329
• NIH Device Record Key: c0a37a93-7746-46c6-acfd-5d4940f990f5
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: ZenSeal
• Version Model Number: 825-9501
• Company DUNS: 199354556
• Company Name: Kerr Corporation
• Device Count: 3
• 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: 1-800-537-7123
• Email: KerrCustCare@kavokerr.com
• Phone: 1-800-537-7123
• Email: KerrCustCare@kavokerr.com
• Phone: 1-800-537-7123
• Email: KerrCustCare@kavokerr.com
• Phone: 1-800-537-7123
• Email: KerrCustCare@kavokerr.com
• Phone: 1-800-537-7123
• Email: KerrCustCare@kavokerr.com
• Phone: 1-800-537-7123
• Email: KerrCustCare@kavokerr.com
• Phone: 1-800-537-7123
• Email: KerrCustCare@kavokerr.com
• Phone: 1-800-537-7123
• Email: KerrCustCare@kavokerr.com
• Phone: 1-800-537-7123
• Email: KerrCustCare@kavokerr.com
• Phone: 1-800-537-7123
• Email: KerrCustCare@kavokerr.com
• Phone: 1-800-537-7123
• Email: KerrCustCare@kavokerr.com
• Phone: 1-800-537-7123
• Email: KerrCustCare@kavokerr.com
• Phone: 1-800-537-7123
• Email: KerrCustCare@kavokerr.com
• Phone: 1-800-537-7123
• Email: KerrCustCare@kavokerr.com
• Phone: 1-800-537-7123
• Email: KerrCustCare@kavokerr.com
• Phone: 1-800-537-7123
• Email: KerrCustCare@kavokerr.com
• Phone: 1-800-537-7123
• Email: KerrCustCare@kavokerr.com
• Phone: 1-800-537-7123
• Email: KerrCustCare@kavokerr.com

Device Dimensions

• Weight: 2 Gram
• Weight: 2 Gram
• Weight: 2 Gram
• Weight: 2 Gram
• Weight: 2 Gram
• Weight: 2 Gram
• Weight: 2 Gram
• Weight: 2 Gram
• Weight: 2 Gram
• Weight: 2 Gram
• Weight: 2 Gram
• Weight: 2 Gram
• Weight: 2 Gram
• Weight: 2 Gram
• Weight: 2 Gram
• Weight: 2 Gram
• Weight: 2 Gram
• Weight: 2 Gram

Operating and Storage Conditions

• Special Storage Condition, Specify: Between 0 and 0 *15°C (59°F) - 25°C (77°F)
• Special Storage Condition, Specify: Between 0 and 0 *15°C (59°F) - 25°C (77°F)
• Special Storage Condition, Specify: Between 0 and 0 *15°C (59°F) - 25°C (77°F)
• Special Storage Condition, Specify: Between 0 and 0 *15°C (59°F) - 25°C (77°F)
• Special Storage Condition, Specify: Between 0 and 0 *15°C (59°F) - 25°C (77°F)
• Special Storage Condition, Specify: Between 0 and 0 *15°C (59°F) - 25°C (77°F)
• Special Storage Condition, Specify: Between 0 and 0 *15°C (59°F) - 25°C (77°F)
• Special Storage Condition, Specify: Between 0 and 0 *15°C (59°F) - 25°C (77°F)
• Special Storage Condition, Specify: Between 0 and 0 *15°C (59°F) - 25°C (77°F)
• Special Storage Condition, Specify: Between 0 and 0 *15°C (59°F) - 25°C (77°F)
• Special Storage Condition, Specify: Between 0 and 0 *15°C (59°F) - 25°C (77°F)
• Special Storage Condition, Specify: Between 0 and 0 *15°C (59°F) - 25°C (77°F)
• Special Storage Condition, Specify: Between 0 and 0 *15°C (59°F) - 25°C (77°F)
• Special Storage Condition, Specify: Between 0 and 0 *15°C (59°F) - 25°C (77°F)
• Special Storage Condition, Specify: Between 0 and 0 *15°C (59°F) - 25°C (77°F)
• Special Storage Condition, Specify: Between 0 and 0 *15°C (59°F) - 25°C (77°F)
• Special Storage Condition, Specify: Between 0 and 0 *15°C (59°F) - 25°C (77°F)
• Special Storage Condition, Specify: Between 0 and 0 *15°C (59°F) - 25°C (77°F)

Device Identifiers

Device Issuing Agency	Device ID
GS1	00195062076329 [Unit of Use]
GS1	00195062076381 [Primary]

FDA Product Code

• KIF: Resin, Root Canal Filling

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: 2023-09-11
• Device Publish Date: 2023-09-01

On-Brand Devices [ZenSeal]

• 00195062076329: Bio Ceramic Root Canal Sealer Syringe and (2x10Pk) Disposable Tips
• 00195062076367: Disposable Tips 10 PK