Opal Seal 500097

GUDID 00883205015709

Metal Opal Seal Tips 500pk

ULTRADENT PRODUCTS, INC.

Syringe tip cap

• Primary Device ID: 00883205015709
• NIH Device Record Key: aa6bfeb2-4309-4dac-b0cf-24beb529176e
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Opal Seal
• Version Model Number: 500097
• Catalog Number: 500097
• 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	00883205015709 [Primary]

FDA Product Code

• EID: SYRINGE, RESTORATIVE AND IMPRESSION MATERIAL

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: 2018-05-29
• Device Publish Date: 2018-04-28

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