OraSeal 354

GUDID 00883205103031

OraSeal Caulking Econo Refill

ULTRADENT PRODUCTS, INC.

Rubber dam, non-latex

• Primary Device ID: 00883205103031
• NIH Device Record Key: 3116a60a-4102-4e7f-8f04-740d86fa7961
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: OraSeal
• Version Model Number: 354
• Catalog Number: 354
• 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: 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: true
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: +1(801)572-4200
• Email: customerservice@ultradent.com

Operating and Storage Conditions

• Storage Environment Temperature: Between 18 Degrees Celsius and 29 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
GS1	00883205103031 [Primary]

FDA Product Code

• EIE: DAM, RUBBER

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: 2018-03-29
• Device Publish Date: 2017-05-23

On-Brand Devices [OraSeal]

• 00883205103543: OraSeal Putty Econo Refill
• 00883205103499: OraSeal Caulking Refill
• 00883205103482: OraSeal Kit
• 00883205103475: OraSeal Putty Refill
• 00883205103031: OraSeal Caulking Econo Refill