TriAway 1375-

GUDID 00883205019998

TriAway Adaptor

ULTRADENT PRODUCTS, INC.

Dental irrigation/aspiration syringe

• Primary Device ID: 00883205019998
• NIH Device Record Key: 01333b0f-0cb1-4f1d-a962-ca57706ff9d8
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: TriAway
• Version Model Number: 1375-
• Catalog Number: 1375-
• 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: true
• 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	00883205019998 [Primary]

FDA Product Code

• EIC: SYRINGE, PERIODONTIC, ENDODONTIC, IRRIGATING

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 [TriAway]

• 00883205019998: TriAway Adaptor
• 00883205031907: TriAway Adaptor