DermaDam 314-

GUDID 00883205015891

DermaDam Heavy 36pk

ULTRADENT PRODUCTS, INC.

Rubber dam, Hevea-latex

• Primary Device ID: 00883205015891
• NIH Device Record Key: a4c729b9-f7de-4247-8331-f52a42331af4
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: DermaDam
• Version Model Number: 314-
• Catalog Number: 314-
• 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: true
• 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	00883205015891 [Primary]

FDA Product Code

• EIE: DAM, RUBBER

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: 2018-10-02
• Device Publish Date: 2018-09-01

On-Brand Devices [DermaDam]

• 00883205015891: DermaDam Heavy 36pk
• 00883205015471: DermaDam Non Latex Med 20pk
• 00883205015457: DermaDam Medium 36pk