Gingival Barrier 9101

GUDID 00883205042545

OEM Venus White Max In-Office Whitening Kit (40005211)

ULTRADENT PRODUCTS, INC.

Rubber dam, non-latex

• Primary Device ID: 00883205042545
• NIH Device Record Key: 10fb9062-1260-418b-9f73-e76e5df8f58b
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Gingival Barrier
• Version Model Number: 9101
• Catalog Number: 9101
• Company DUNS: 013369913
• Company Name: ULTRADENT PRODUCTS, INC.
• 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: true
• Device Combination Product: false
• Single Use: true
• 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: 801-619-0298
• Email: orders@oratech.com
• Phone: 801-619-0298
• Email: orders@oratech.com
• Phone: 801-619-0298
• Email: orders@oratech.com
• Phone: 801-619-0298
• Email: orders@oratech.com
• Phone: 801-619-0298
• Email: orders@oratech.com
• Phone: 801-619-0298
• Email: orders@oratech.com
• Phone: 801-619-0298
• Email: orders@oratech.com
• Phone: 801-619-0298
• Email: orders@oratech.com
• Phone: 801-619-0298
• Email: orders@oratech.com
• Phone: 801-619-0298
• Email: orders@oratech.com
• Phone: 801-619-0298
• Email: orders@oratech.com
• Phone: 801-619-0298
• Email: orders@oratech.com
• Phone: 801-619-0298
• Email: orders@oratech.com
• Phone: 801-619-0298
• Email: orders@oratech.com
• Phone: 801-619-0298
• Email: orders@oratech.com
• Phone: 801-619-0298
• Email: orders@oratech.com
• Phone: 801-619-0298
• Email: orders@oratech.com

Operating and Storage Conditions

• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
GS1	00883205042545 [Primary]

FDA Product Code

• EIG: Retractor, All Types

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: 2025-03-03
• Device Publish Date: 2025-02-22

On-Brand Devices [Gingival Barrier]

• 00883205042545: OEM Venus White Max In-Office Whitening Kit (40005211)
• 00883205042521: OEM Venus White Max Gingival Barrier Kit 1.2ml (40005202)