Opal Seal 500034-

GUDID 00883205015266

Opal Seal Tips 100 Pack

ULTRADENT PRODUCTS, INC.

Syringe tip cap

• Primary Device ID: 00883205015266
• NIH Device Record Key: 7fb8eb1f-64c6-48b5-974f-4ccfdcdb078c
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Opal Seal
• Version Model Number: 500034-
• Catalog Number: 500034-
• Company DUNS: 013369913
• Company Name: ULTRADENT PRODUCTS, INC.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: true
• 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: false
• Expiration Date: false
• 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(801)572-4200
• Email: customerservice@ultradent.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	00883205015266 [Primary]

FDA Product Code

• KXR: APPLICATOR, 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: 2018-10-01
• Device Publish Date: 2018-08-31

On-Brand Devices [Opal Seal]

• 00883205103284: Opal Seal Trial Syringe
• 00883205103277: Opal Seal Refill
• 00883205103260: Opal Seal Kit
• 00883205103253: Opal Seal Intro Kit
• 00883205103239: Opal Seal Adhesives Trial Kit
• 00883205015709: Metal Opal Seal Tips 500pk
• 00883205015686: Metal Opal Seal Tips 100 Pack
• 00883205015679: Metal Opal Seal Tips 20 Pack
• 00883205015488: Opal Seal Tips 20 Pack
• 00883205015266: Opal Seal Tips 100 Pack