HurriSeal Dentin Desensitizer 12mL

GUDID 10723797697822

Dentin desensitizing liquid formula. 1 x 12mL bottle in a box.

BEUTLICH PHARMACEUTICALS, LLC

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• Primary Device ID: 10723797697822
• NIH Device Record Key: daecb5d6-3ece-4cba-8542-4dfd52888f6a
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: HurriSeal Dentin Desensitizer 12mL
• Version Model Number: 12mL bottle
• Company DUNS: 005209325
• Company Name: BEUTLICH PHARMACEUTICALS, LLC
• 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: false
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: false
• OTC Over-The-Counter: true

Customer Support Contacts

• Phone: 1-800-238-8542
• Email: regulatory@beutlich.com
• Phone: 1-800-238-8542
• Email: regulatory@beutlich.com
• Phone: 1-800-238-8542
• Email: regulatory@beutlich.com
• Phone: 1-800-238-8542
• Email: regulatory@beutlich.com
• Phone: 1-800-238-8542
• Email: regulatory@beutlich.com
• Phone: 1-800-238-8542
• Email: regulatory@beutlich.com
• Phone: 1-800-238-8542
• Email: regulatory@beutlich.com
• Phone: 1-800-238-8542
• Email: regulatory@beutlich.com
• Phone: 1-800-238-8542
• Email: regulatory@beutlich.com
• Phone: 1-800-238-8542
• Email: regulatory@beutlich.com
• Phone: 1-800-238-8542
• Email: regulatory@beutlich.com
• Phone: 1-800-238-8542
• Email: regulatory@beutlich.com
• Phone: 1-800-238-8542
• Email: regulatory@beutlich.com
• Phone: 1-800-238-8542
• Email: regulatory@beutlich.com
• Phone: 1-800-238-8542
• Email: regulatory@beutlich.com

Operating and Storage Conditions

• Storage Environment Temperature: Between 0 Degrees Celsius and 25 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Refrigerate if not used for long periods of time.
• Special Storage Condition, Specify: Between 0 and 0 *Do not freeze.
• Storage Environment Temperature: Between 0 Degrees Celsius and 25 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Refrigerate if not used for long periods of time.
• Special Storage Condition, Specify: Between 0 and 0 *Do not freeze.
• Storage Environment Temperature: Between 0 Degrees Celsius and 25 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Refrigerate if not used for long periods of time.
• Special Storage Condition, Specify: Between 0 and 0 *Do not freeze.
• Storage Environment Temperature: Between 0 Degrees Celsius and 25 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Refrigerate if not used for long periods of time.
• Special Storage Condition, Specify: Between 0 and 0 *Do not freeze.
• Storage Environment Temperature: Between 0 Degrees Celsius and 25 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Refrigerate if not used for long periods of time.
• Special Storage Condition, Specify: Between 0 and 0 *Do not freeze.
• Storage Environment Temperature: Between 0 Degrees Celsius and 25 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Refrigerate if not used for long periods of time.
• Special Storage Condition, Specify: Between 0 and 0 *Do not freeze.
• Storage Environment Temperature: Between 0 Degrees Celsius and 25 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Refrigerate if not used for long periods of time.
• Special Storage Condition, Specify: Between 0 and 0 *Do not freeze.
• Storage Environment Temperature: Between 0 Degrees Celsius and 25 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Refrigerate if not used for long periods of time.
• Special Storage Condition, Specify: Between 0 and 0 *Do not freeze.
• Storage Environment Temperature: Between 0 Degrees Celsius and 25 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Refrigerate if not used for long periods of time.
• Special Storage Condition, Specify: Between 0 and 0 *Do not freeze.
• Storage Environment Temperature: Between 0 Degrees Celsius and 25 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Refrigerate if not used for long periods of time.
• Special Storage Condition, Specify: Between 0 and 0 *Do not freeze.
• Storage Environment Temperature: Between 0 Degrees Celsius and 25 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Refrigerate if not used for long periods of time.
• Special Storage Condition, Specify: Between 0 and 0 *Do not freeze.
• Storage Environment Temperature: Between 0 Degrees Celsius and 25 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Refrigerate if not used for long periods of time.
• Special Storage Condition, Specify: Between 0 and 0 *Do not freeze.
• Storage Environment Temperature: Between 0 Degrees Celsius and 25 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Refrigerate if not used for long periods of time.
• Special Storage Condition, Specify: Between 0 and 0 *Do not freeze.
• Storage Environment Temperature: Between 0 Degrees Celsius and 25 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Refrigerate if not used for long periods of time.
• Special Storage Condition, Specify: Between 0 and 0 *Do not freeze.
• Storage Environment Temperature: Between 0 Degrees Celsius and 25 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Refrigerate if not used for long periods of time.
• Special Storage Condition, Specify: Between 0 and 0 *Do not freeze.

Device Identifiers

Device Issuing Agency	Device ID
GS1	01723797697824 [Previous]
GS1	10723797697822 [Primary]
GS1	20723797697829 [Package]; Package: 72 in a case [72 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K973002

FDA Product Code

• KLE: Agent, Tooth Bonding, Resin

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 2
• Public Version Date: 2020-11-05
• Device Publish Date: 2020-01-07

On-Brand Devices [HurriSeal Dentin Desensitizer 12mL]

• 01723797697824: 12mL bottle - dentin desensitizing liquid formula.
• 10723797697822: Dentin desensitizing liquid formula. 1 x 12mL bottle in a box.